Trial Outcomes & Findings for Novel Experimental COVID-19 Therapies Affecting Host Response (NCT NCT04924660)
NCT ID: NCT04924660
Last Updated: 2025-01-22
Results Overview
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1060 participants
Primary outcome timeframe
Day 1 to Day 28
Results posted on
2025-01-22
Participant Flow
This adaptive platform study consisted of 3 trials, each designed to assess a candidate agent as treatment for coronavirus disease 2019 (COVID-19) in hospitalized adult patients who had severe infection with acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The control group for each trial includes all participants that were eligible for that trial and received a placebo mimic for any of the three study agents (shared placebo).
Adults hospitalized with COVID-19 were enrolled with no exclusions based on age, sex, race, ethnicity, severity of disease or preferred language. If a patient appeared to meet eligibility criteria, the site investigator approached the treating clinician to ask permission to approach the patient to confirm eligibility, discuss potential study recruitment, and proceed with informed consent. The eligibility criteria were verified and informed consent was obtained just prior to randomization.
Participant milestones
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
United States
STARTED
|
176
|
175
|
149
|
147
|
193
|
192
|
|
United States
COMPLETED
|
124
|
130
|
99
|
114
|
140
|
145
|
|
United States
NOT COMPLETED
|
52
|
45
|
50
|
33
|
53
|
47
|
|
Spain
STARTED
|
0
|
0
|
0
|
0
|
10
|
9
|
|
Spain
COMPLETED
|
0
|
0
|
0
|
0
|
9
|
7
|
|
Spain
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Brazil
STARTED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Brazil
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Brazil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Germany
STARTED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Germany
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Germany
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Italy
STARTED
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Italy
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Italy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
South Africa
STARTED
|
0
|
0
|
0
|
0
|
2
|
3
|
|
South Africa
COMPLETED
|
0
|
0
|
0
|
0
|
2
|
1
|
|
South Africa
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Shared Placebo
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Shared Placebo
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Shared Placebo
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
United States
Death
|
29
|
32
|
34
|
25
|
26
|
23
|
|
United States
Lost to Follow-up
|
15
|
10
|
13
|
5
|
19
|
20
|
|
United States
Withdrawal by Subject
|
8
|
3
|
3
|
3
|
8
|
4
|
|
Spain
Death
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Spain
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Brazil
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Italy
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
South Africa
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
|
South Africa
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
Baseline characteristics by cohort
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=176 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Shared Placebo
n=175 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=149 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Shared Placebo
n=147 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=207 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Shared Placebo
n=206 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Total
n=1060 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
All Countries · <=18 years
|
0 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
All Countries · Between 18 and 65 years
|
121 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
128 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
109 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
107 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
88 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
81 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
634 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
All Countries · >=65 years
|
55 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
47 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
40 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
40 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
119 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
125 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
426 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
United States · <=18 years
|
0 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
United States · Between 18 and 65 years
|
121 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
128 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
109 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
107 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
84 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
78 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
627 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
United States · >=65 years
|
55 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
47 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
40 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
40 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
109 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
114 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
405 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Spain · <=18 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Spain · Between 18 and 65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Spain · >=65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
8 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
7 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
15 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Brazil · <=18 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Brazil · Between 18 and 65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Brazil · >=65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Germany · <=18 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Germany · Between 18 and 65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Germany · >=65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Italy · <=18 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Italy · Between 18 and 65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
Italy · >=65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
South Africa · <=18 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
South Africa · Between 18 and 65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Age, Categorical
South Africa · >=65 years
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
3 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
All Countries · Female
|
70 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
76 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
54 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
69 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
103 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
95 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
467 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
All Countries · Male
|
106 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
99 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
95 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
78 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
104 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
111 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
593 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
United States · Female
|
70 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
76 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
54 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
69 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
97 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
89 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
455 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
United States · Male
|
106 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
99 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
95 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
78 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
96 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
103 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
577 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
Spain · Female
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
3 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
7 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
Spain · Male
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
7 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
5 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
12 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
Brazil · Female
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
Brazil · Male
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
Germany · Female
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
Germany · Male
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
Italy · Female
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
—
|
—
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
Italy · Male
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
—
|
—
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
South Africa · Female
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Sex: Female, Male
South Africa · Male
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
3 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
All Countries · Hispanic or Latino
|
28 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
26 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
25 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
23 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
27 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
30 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
159 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
All Countries · Not Hispanic or Latino
|
140 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
140 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
113 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
116 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
174 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
165 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
848 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
All Countries · Unknown or Not Reported
|
8 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
9 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
11 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
8 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
6 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
11 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
53 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
United States · Hispanic or Latino
|
28 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
26 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
25 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
23 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
21 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
25 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
148 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
United States · Not Hispanic or Latino
|
140 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
140 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
113 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
116 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
170 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
161 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
840 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
United States · Unknown or Not Reported
|
8 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
9 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
11 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
8 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
6 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
44 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Spain · Hispanic or Latino
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
5 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
5 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
10 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Spain · Not Hispanic or Latino
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Spain · Unknown or Not Reported
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
8 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Brazil · Hispanic or Latino
|
—
|
—
|
—
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Brazil · Not Hispanic or Latino
|
—
|
—
|
—
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Brazil · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Germany · Hispanic or Latino
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Germany · Not Hispanic or Latino
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Germany · Unknown or Not Reported
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Italy · Hispanic or Latino
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Italy · Not Hispanic or Latino
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
Italy · Unknown or Not Reported
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
South Africa · Hispanic or Latino
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
South Africa · Not Hispanic or Latino
|
00 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
3 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
5 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Ethnicity (NIH/OMB)
South Africa · Unknown or Not Reported
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
All Countries · American Indian or Alaska Native
|
5 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
15 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
All Countries · Asian
|
4 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
3 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
6 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
6 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
25 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
All Countries · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
3 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
All Countries · Black or African American
|
29 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
30 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
25 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
22 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
24 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
23 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
153 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
All Countries · White
|
115 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
114 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
101 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
97 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
149 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
160 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
736 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
All Countries · More than one race
|
1 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
All Countries · Unknown or Not Reported
|
22 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
25 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
19 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
24 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
22 Participants
n=207 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
13 Participants
n=206 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
125 Participants
n=1060 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
United States · American Indian or Alaska Native
|
5 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
15 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
United States · Asian
|
4 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
3 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
6 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
6 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
25 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
United States · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
3 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
United States · Black or African American
|
29 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
30 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
25 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
22 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
22 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
21 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
149 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
United States · White
|
115 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
114 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
101 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
97 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
139 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
148 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
714 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
United States · More than one race
|
1 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
United States · Unknown or Not Reported
|
22 Participants
n=176 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
25 Participants
n=175 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
19 Participants
n=149 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
24 Participants
n=147 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
20 Participants
n=193 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
13 Participants
n=192 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
123 Participants
n=1032 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Spain · American Indian or Alaska Native
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Spain · Asian
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Spain · Native Hawaiian or Other Pacific Islander
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Spain · Black or African American
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Spain · White
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
9 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
9 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
18 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Spain · More than one race
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Spain · Unknown or Not Reported
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=10 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=9 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=19 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Brazil · American Indian or Alaska Native
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Brazil · Asian
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Brazil · Native Hawaiian or Other Pacific Islander
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Brazil · Black or African American
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Brazil · White
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Brazil · More than one race
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Brazil · Unknown or Not Reported
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Germany · American Indian or Alaska Native
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Germany · Asian
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Germany · Native Hawaiian or Other Pacific Islander
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Germany · Black or African American
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Germany · White
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Germany · More than one race
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Germany · Unknown or Not Reported
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Italy · American Indian or Alaska Native
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Italy · Asian
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Italy · Native Hawaiian or Other Pacific Islander
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Italy · Black or African American
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Italy · White
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Italy · More than one race
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
Italy · Unknown or Not Reported
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=1 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
South Africa · American Indian or Alaska Native
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
South Africa · Asian
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
South Africa · Native Hawaiian or Other Pacific Islander
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
South Africa · Black or African American
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
2 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
4 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
South Africa · White
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
1 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
South Africa · More than one race
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Race (NIH/OMB)
South Africa · Unknown or Not Reported
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=2 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=3 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
0 Participants
n=5 Participants • Results data includes data from NCT05593770. All Countries = all participant data The remaining rows are data by country.
|
|
Region of Enrollment
United States
|
176 participants
n=176 Participants
|
175 participants
n=175 Participants
|
149 participants
n=149 Participants
|
147 participants
n=147 Participants
|
193 participants
n=207 Participants
|
192 participants
n=206 Participants
|
871 participants
n=1060 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=176 Participants
|
0 participants
n=175 Participants
|
0 participants
n=149 Participants
|
0 participants
n=147 Participants
|
10 participants
n=207 Participants
|
9 participants
n=206 Participants
|
19 participants
n=1060 Participants
|
|
Region of Enrollment
Brazil
|
0 participants
n=176 Participants
|
0 participants
n=175 Participants
|
0 participants
n=149 Participants
|
0 participants
n=147 Participants
|
1 participants
n=207 Participants
|
0 participants
n=206 Participants
|
1 participants
n=1060 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=176 Participants
|
0 participants
n=175 Participants
|
0 participants
n=149 Participants
|
0 participants
n=147 Participants
|
0 participants
n=207 Participants
|
1 participants
n=206 Participants
|
1 participants
n=1060 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=176 Participants
|
0 participants
n=175 Participants
|
0 participants
n=149 Participants
|
0 participants
n=147 Participants
|
1 participants
n=207 Participants
|
1 participants
n=206 Participants
|
2 participants
n=1060 Participants
|
|
Region of Enrollment
South Africa
|
0 participants
n=176 Participants
|
0 participants
n=175 Participants
|
0 participants
n=149 Participants
|
0 participants
n=147 Participants
|
2 participants
n=207 Participants
|
3 participants
n=206 Participants
|
5 participants
n=1060 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=153 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=155 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=135 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=131 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=177 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=181 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Oxygen Free Days Through Day 28.
All Countries
|
9.0 Days
Standard Deviation 10.9
|
11.3 Days
Standard Deviation 11.5
|
8.1 Days
Standard Deviation 10.8
|
10.5 Days
Standard Deviation 11.5
|
13.4 Days
Standard Deviation 12.4
|
14.2 Days
Standard Deviation 12.1
|
|
Oxygen Free Days Through Day 28.
United States
|
9.0 Days
Standard Deviation 10.9
|
11.3 Days
Standard Deviation 11.5
|
8.1 Days
Standard Deviation 10.8
|
10.5 Days
Standard Deviation 11.5
|
12.9 Days
Standard Deviation 12.5
|
13.9 Days
Standard Deviation 12
|
|
Oxygen Free Days Through Day 28.
Spain
|
—
|
—
|
—
|
—
|
21.3 Days
Standard Deviation 8.2
|
19.5 Days
Standard Deviation 12.5
|
|
Oxygen Free Days Through Day 28.
Brazil
|
—
|
—
|
—
|
—
|
-1 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
—
|
|
Oxygen Free Days Through Day 28.
Germany
|
—
|
—
|
—
|
—
|
—
|
0 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
|
Oxygen Free Days Through Day 28.
Italy
|
—
|
—
|
—
|
—
|
14 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
—
|
|
Oxygen Free Days Through Day 28.
South Africa
|
—
|
—
|
—
|
—
|
25.5 Days
Standard Deviation 3.5
|
26.5 Days
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Day 1 to hospital discharge or Day 90 whichever comes firstPopulation: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of patients who die during hospitalization
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=167 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=172 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=145 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=144 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=197 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=197 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
In-hospital Mortality
All Countries
|
23 Participants
|
24 Participants
|
31 Participants
|
20 Participants
|
23 Participants
|
16 Participants
|
|
In-hospital Mortality
United States
|
23 Participants
|
24 Participants
|
31 Participants
|
20 Participants
|
22 Participants
|
15 Participants
|
|
In-hospital Mortality
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
In-hospital Mortality
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
In-hospital Mortality
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
In-hospital Mortality
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
In-hospital Mortality
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 14Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=158 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=164 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=138 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=137 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=189 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=191 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Alive and Oxygen Free at Day 14
All Countries
|
60 Participants
|
86 Participants
|
48 Participants
|
66 Participants
|
113 Participants
|
113 Participants
|
|
Alive and Oxygen Free at Day 14
United States
|
60 Participants
|
86 Participants
|
48 Participants
|
66 Participants
|
103 Participants
|
105 Participants
|
|
Alive and Oxygen Free at Day 14
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
6 Participants
|
|
Alive and Oxygen Free at Day 14
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Alive and Oxygen Free at Day 14
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Alive and Oxygen Free at Day 14
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Alive and Oxygen Free at Day 14
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of patients oxygen-free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=155 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=158 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=135 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=134 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=187 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=189 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Alive and Oxygen Free at Day 28
All Countries
|
78 Participants
|
87 Participants
|
60 Participants
|
69 Participants
|
106 Participants
|
123 Participants
|
|
Alive and Oxygen Free at Day 28
United States
|
78 Participants
|
87 Participants
|
60 Participants
|
69 Participants
|
95 Participants
|
114 Participants
|
|
Alive and Oxygen Free at Day 28
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
7 Participants
|
|
Alive and Oxygen Free at Day 28
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Alive and Oxygen Free at Day 28
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Alive and Oxygen Free at Day 28
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Alive and Oxygen Free at Day 28
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of patients alive free of new invasive mechanical ventilation at day 28
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=155 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=160 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=136 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=136 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=186 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=190 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Alive and Free of New Invasive Mechanical Ventilation at Day 28
All Countries
|
124 Participants
|
128 Participants
|
99 Participants
|
109 Participants
|
160 Participants
|
171 Participants
|
|
Alive and Free of New Invasive Mechanical Ventilation at Day 28
United States
|
124 Participants
|
128 Participants
|
99 Participants
|
109 Participants
|
148 Participants
|
160 Participants
|
|
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
8 Participants
|
|
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Alive and Free of New Invasive Mechanical Ventilation at Day 28
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of patients who have died at Day 28
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=163 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=166 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=141 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=140 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=195 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=197 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
28-day Mortality
All Countries
|
22 Participants
|
22 Participants
|
29 Participants
|
18 Participants
|
22 Participants
|
16 Participants
|
|
28-day Mortality
United States
|
22 Participants
|
22 Participants
|
29 Participants
|
18 Participants
|
21 Participants
|
15 Participants
|
|
28-day Mortality
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
28-day Mortality
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
28-day Mortality
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
28-day Mortality
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
28-day Mortality
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 60Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of patients who have died at Day 60
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=161 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=166 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=139 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=140 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=195 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=195 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
60-day Mortality
All Countries
|
26 Participants
|
29 Participants
|
33 Participants
|
23 Participants
|
25 Participants
|
22 Participants
|
|
60-day Mortality
United States
|
26 Participants
|
29 Participants
|
33 Participants
|
23 Participants
|
24 Participants
|
20 Participants
|
|
60-day Mortality
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
60-day Mortality
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
60-day Mortality
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
60-day Mortality
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
60-day Mortality
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 90Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of patients who have died at Day 90
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=158 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=161 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=135 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=138 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=186 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=186 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
90-day Mortality
All Countries
|
28 Participants
|
31 Participants
|
34 Participants
|
25 Participants
|
27 Participants
|
26 Participants
|
|
90-day Mortality
United States
|
28 Participants
|
31 Participants
|
34 Participants
|
25 Participants
|
26 Participants
|
23 Participants
|
|
90-day Mortality
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
90-day Mortality
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
90-day Mortality
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
90-day Mortality
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
90-day Mortality
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=158 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=164 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=138 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=137 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=188 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=191 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Germany Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Germany Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Germany Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Germany Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Germany Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Italy=Score1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Italy Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Italy Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Italy Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Italy Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Italy Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Italy Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Italy Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
South Africa Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
South Africa Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
South Africa Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
South Africa Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
South Africa Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
South Africa Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Alll Countries Score=1
|
37 Participants
|
57 Participants
|
31 Participants
|
45 Participants
|
53 Participants
|
75 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Alll Countries Score=2
|
61 Participants
|
53 Participants
|
50 Participants
|
48 Participants
|
79 Participants
|
77 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Alll Countries Score=3
|
5 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
4 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Alll Countries Score=4
|
19 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
20 Participants
|
14 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Alll Countries Score=5
|
6 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Alll Countries Score=6
|
6 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Alll Countries Score =7
|
12 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
3 Participants
|
7 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Alll Countries Score=8
|
12 Participants
|
13 Participants
|
21 Participants
|
11 Participants
|
11 Participants
|
10 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
United States Score=1
|
37 Participants
|
57 Participants
|
31 Participants
|
45 Participants
|
45 Participants
|
68 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
United States Score=2
|
61 Participants
|
55 Participants
|
50 Participants
|
48 Participants
|
76 Participants
|
59 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
United States Score=3
|
5 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
3 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
United States Score=4
|
19 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
19 Participants
|
11 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
United States Score=5
|
6 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
United States Score=6
|
6 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
United States Score=7
|
12 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
1 Participants
|
7 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
United States Score=8
|
12 Participants
|
13 Participants
|
21 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Spain Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
5 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Spain Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Spain Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Spain Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Spain Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Spain Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Spain Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Spain Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Brazil Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Brazil Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Brazil Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Brazil Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Brazil Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Brazil Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Brazil Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Brazil Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Germany Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Germany Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Germany Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
South Africa Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
South Africa Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=154 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=158 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=135 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=134 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=182 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=189 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Brazil Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
United States Score=8
|
22 Participants
|
22 Participants
|
29 Participants
|
18 Participants
|
21 Participants
|
15 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Spain Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Spain Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Spain Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Spain Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Spain Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Spain Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Spain Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Spain Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Brazil Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Brazil Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Brazil Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Brazil Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Brazil Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Brazil Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Brazil Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
All Countries Score=1
|
58 Participants
|
62 Participants
|
48 Participants
|
47 Participants
|
63 Participants
|
74 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Germany Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Germany Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
All Countries Score=2
|
53 Participants
|
58 Participants
|
44 Participants
|
53 Participants
|
76 Participants
|
88 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
All Countries Score=3
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Germany Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
All Countries Score=5
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
All Countries Score=6
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
All Countries Score=7
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
All Countries Score=8
|
22 Participants
|
22 Participants
|
29 Participants
|
18 Participants
|
22 Participants
|
16 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
United States Score=1
|
58 Participants
|
62 Participants
|
48 Participants
|
47 Participants
|
56 Participants
|
67 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Germany Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
United States Score=2
|
53 Participants
|
58 Participants
|
44 Participants
|
53 Participants
|
75 Participants
|
85 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
United States Score=3
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
United States Score=4
|
7 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
United States Score=5
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
United States Score=6
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Germany Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
United States Score=7
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Italy Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Italy Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Germany Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Italy Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Italy Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Italy Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Germany Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Italy Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Italy Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
South Africa Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
South Africa Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Germany Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
South Africa Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
South Africa Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
South Africa Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
South Africa Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
South Africa Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Italy Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
South Africa Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
All Countries Score=4
|
7 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 60Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=128 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=140 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=108 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=115 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=161 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=167 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
United States Score=2
|
61 Participants
|
55 Participants
|
50 Participants
|
48 Participants
|
76 Participants
|
76 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
All Countries Score=1
|
37 Participants
|
57 Participants
|
31 Participants
|
45 Participants
|
53 Participants
|
75 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
All Countries Score=2
|
61 Participants
|
55 Participants
|
50 Participants
|
48 Participants
|
79 Participants
|
77 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
All Countries Score=3
|
5 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
4 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
All Countries Score=4
|
19 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
20 Participants
|
14 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
All Countries Score=5
|
6 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
All Countries Score=6
|
6 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
All Countries Score=7
|
12 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
3 Participants
|
7 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
All Countries Score=8
|
12 Participants
|
13 Participants
|
21 Participants
|
21 Participants
|
11 Participants
|
10 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
United States Score=1
|
37 Participants
|
57 Participants
|
31 Participants
|
45 Participants
|
45 Participants
|
69 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
United States Score=3
|
5 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
3 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
United States Score=4
|
19 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
19 Participants
|
11 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
United States Score=5
|
6 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
United States Score=6
|
6 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
United States Score=7
|
12 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
3 Participants
|
7 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
United States Score=8
|
12 Participants
|
13 Participants
|
21 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Spain Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Spain Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Spain Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Spain Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Spain Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Spain Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Spain Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Spain Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Brazil Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Brazil Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Brazil Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Brazil Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Brazil Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Brazil Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Brazil Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Brazil Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Germany Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Germany Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Germany Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Germany Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Germany Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Germany Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Germany Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Germany Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
South Africa Score=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
South Africa Score=2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
South Africa Score=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
South Africa Score=4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
South Africa Score=5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
South Africa Score=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
South Africa Score=7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
South Africa Score=8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Days alive and not hospitalized during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=154 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=160 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=136 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=136 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=184 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=190 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Hospital-free Days Through Day 28
All Countries
|
9.0 Days
Standard Deviation 10.9
|
11.3 Days
Standard Deviation 11.5
|
8.1 Days
Standard Deviation 10.8
|
10.5 Days
Standard Deviation 11.5
|
13.4 Days
Standard Deviation 12.4
|
14.2 Days
Standard Deviation 12.1
|
|
Hospital-free Days Through Day 28
United States
|
9.0 Days
Standard Deviation 10.9
|
11.3 Days
Standard Deviation 11.5
|
8.1 Days
Standard Deviation 10.8
|
10.5 Days
Standard Deviation 11.5
|
12.9 Days
Standard Deviation 12.5
|
13.9 Days
Standard Deviation 12
|
|
Hospital-free Days Through Day 28
Spain
|
—
|
—
|
—
|
—
|
21.3 Days
Standard Deviation 8.2
|
19.5 Days
Standard Deviation 12.5
|
|
Hospital-free Days Through Day 28
Brazil
|
—
|
—
|
—
|
—
|
-1 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
—
|
|
Hospital-free Days Through Day 28
Germany
|
—
|
—
|
—
|
—
|
—
|
0 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
|
Hospital-free Days Through Day 28
Italy
|
—
|
—
|
—
|
—
|
14 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
—
|
|
Hospital-free Days Through Day 28
South Africa
|
—
|
—
|
—
|
—
|
25.5 Days
Standard Deviation 3.5
|
26.5 Days
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Days alive and not receiving mechanical ventilation during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=150 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=159 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=135 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=135 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=177 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=186 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Ventilator-free Days Through Day 28
All Countries
|
9.0 Days
Standard Deviation 10.9
|
11.3 Days
Standard Deviation 11.5
|
8.1 Days
Standard Deviation 10.8
|
10.5 Days
Standard Deviation 11.5
|
12.9 Days
Standard Deviation 12.5
|
13.9 Days
Standard Deviation 12
|
|
Ventilator-free Days Through Day 28
United States
|
9.0 Days
Standard Deviation 10.9
|
11.3 Days
Standard Deviation 11.5
|
8.1 Days
Standard Deviation 10.8
|
10.5 Days
Standard Deviation 11.5
|
12.9 Days
Standard Deviation 12.5
|
13.9 Days
Standard Deviation 12
|
|
Ventilator-free Days Through Day 28
Spain
|
—
|
—
|
—
|
—
|
21.3 Days
Standard Deviation 8.2
|
19.5 Days
Standard Deviation 12.5
|
|
Ventilator-free Days Through Day 28
Brazil
|
—
|
—
|
—
|
—
|
-1 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
—
|
|
Ventilator-free Days Through Day 28
Germany
|
—
|
—
|
—
|
—
|
—
|
0 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
|
Ventilator-free Days Through Day 28
Italy
|
—
|
—
|
—
|
—
|
14 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
—
|
|
Ventilator-free Days Through Day 28
South Africa
|
—
|
—
|
—
|
—
|
25.5 Days
Standard Deviation 3.5
|
26.5 Days
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Days alive and not in respiratory failure during the first 28 days following randomization. A respiratory failure-free day is defined as a day alive without the use of HFNC, NIV, IMV, or (ECMO). Patients who die on or before day 28 are assigned a value -1.
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=150 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=160 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=135 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=136 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=177 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=186 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Respiratory Failure-free Days Through Day 28
All Countries
|
9.0 Days
Standard Deviation 10.9
|
11.3 Days
Standard Deviation 11.5
|
8.1 Days
Standard Deviation 10.8
|
10.5 Days
Standard Deviation 11.5
|
13.4 Days
Standard Deviation 12.4
|
14.2 Days
Standard Deviation 12.1
|
|
Respiratory Failure-free Days Through Day 28
United States
|
9.0 Days
Standard Deviation 10.9
|
11.3 Days
Standard Deviation 11.5
|
8.1 Days
Standard Deviation 10.8
|
10.5 Days
Standard Deviation 11.5
|
12.9 Days
Standard Deviation 12.5
|
13.9 Days
Standard Deviation 12
|
|
Respiratory Failure-free Days Through Day 28
Spain
|
—
|
—
|
—
|
—
|
21.3 Days
Standard Deviation 8.2
|
19.5 Days
Standard Deviation 12.5
|
|
Respiratory Failure-free Days Through Day 28
Brazil
|
—
|
—
|
—
|
—
|
-1 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
—
|
|
Respiratory Failure-free Days Through Day 28
Germany
|
—
|
—
|
—
|
—
|
—
|
0 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
|
Respiratory Failure-free Days Through Day 28
Italy
|
—
|
—
|
—
|
—
|
14 Days
Standard Deviation NA
Unable to provide standard deviation only 1 participant affected
|
—
|
|
Respiratory Failure-free Days Through Day 28
South Africa
|
—
|
—
|
—
|
—
|
25.3 Days
Standard Deviation 3.5
|
26.5 Days
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to Day 5 or hospital discharge whichever comes firstPopulation: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of participants with hypotension defined by low arterial blood pressure leading to either \[1\] initiation or increase in vasopressor therapy, \[2\] administration of a fluid bolus of 500 ml or more, or \[3\] modification of the dose or discontinuation of the study drug.
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=170 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=173 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=145 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=145 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=199 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=201 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Hypotension
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hypotension
All Countries
|
31 Participants
|
31 Participants
|
32 Participants
|
25 Participants
|
24 Participants
|
18 Participants
|
|
Hypotension
United States
|
31 Participants
|
31 Participants
|
32 Participants
|
25 Participants
|
23 Participants
|
17 Participants
|
|
Hypotension
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Hypotension
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Hypotension
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Hypotension
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to Day 5 or hospital discharge whichever comes firstPopulation: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of participants with allergic reaction, including rash and angioedema
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=170 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=173 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=145 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=145 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=199 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=201 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Allergic Reaction
All Countries
|
3 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Allergic Reaction
United States
|
3 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Allergic Reaction
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Allergic Reaction
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Allergic Reaction
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Allergic Reaction
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Allergic Reaction
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to Day 5 or hospital discharge whichever comes firstPopulation: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
Number of participants requiring renal replacement therapy during hospitalization (when possible, at participating sites)
Outcome measures
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=170 Participants
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=173 Participants
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=145 Participants
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=145 Participants
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=199 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=201 Participants
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Incident Renal Replacement Therapy During Hospitalization
All Countries
|
11 Participants
|
12 Participants
|
9 Participants
|
11 Participants
|
5 Participants
|
9 Participants
|
|
Incident Renal Replacement Therapy During Hospitalization
United States
|
11 Participants
|
12 Participants
|
9 Participants
|
11 Participants
|
15 Participants
|
9 Participants
|
|
Incident Renal Replacement Therapy During Hospitalization
Spain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incident Renal Replacement Therapy During Hospitalization
Brazil
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incident Renal Replacement Therapy During Hospitalization
Germany
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incident Renal Replacement Therapy During Hospitalization
Italy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incident Renal Replacement Therapy During Hospitalization
South Africa
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
TXA127 (4/20/2022 Arm Closed to Accrual)
Serious events: 8 serious events
Other events: 29 other events
Deaths: 29 deaths
TXA127 Placebo
Serious events: 4 serious events
Other events: 5 other events
Deaths: 32 deaths
TRV027 (4/20/2022 Arm Closed to Accrual)
Serious events: 6 serious events
Other events: 3 other events
Deaths: 34 deaths
TRV027 Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 25 deaths
Fostamatinib
Serious events: 16 serious events
Other events: 18 other events
Deaths: 27 deaths
Fostamatinib Placebo
Serious events: 44 serious events
Other events: 25 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=176 participants at risk
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=175 participants at risk
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=149 participants at risk
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=147 participants at risk
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=193 participants at risk
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=192 participants at risk
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
2.1%
4/193 • Number of events 4 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.67%
1/149 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/193 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
General disorders
Asthenia
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/193 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
2.6%
5/192 • Number of events 5 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Infection
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Lower respiratory tract infection bacteria
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.57%
1/175 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.68%
1/147 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
2.1%
4/192 • Number of events 5 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.57%
1/175 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Pneumonia bacterial
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.57%
1/175 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.68%
1/147 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Urinary tract infection
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.57%
1/175 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Vulval cellulitis
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Nervous system disorders
Syncope
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.67%
1/149 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/193 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.6%
3/192 • Number of events 3 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.67%
1/149 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/192 • Number of events 3 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Surgical and medical procedures
Tricuspid valve replacement
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Vascular disorders
Arterial thrombosis
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Vascular disorders
Hypotension
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.3%
2/149 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Vascular disorders
Shock
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.67%
1/149 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
Other adverse events
| Measure |
TXA127 (4/20/2022 Arm Closed to Accrual)
n=176 participants at risk
An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
|
TXA127 Placebo
n=175 participants at risk
NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
TRV027 (4/20/2022 Arm Closed to Accrual)
n=149 participants at risk
An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
|
TRV027 Placebo
n=147 participants at risk
NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
Fostamatinib
n=193 participants at risk
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Fostamatinib Placebo
n=192 participants at risk
Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Cardiac disorders
Bradycardia
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Eye disorders
Vision blurred
|
1.1%
2/176 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/193 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/176 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.3%
2/149 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Oral Disorder
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.68%
1/147 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
General disorders
Discomfort
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
General disorders
Extravasation
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
General disorders
Infusion site erythema
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
General disorders
Mass
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
General disorders
Oedema peripheral
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
3.1%
6/193 • Number of events 6 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Pneumonia
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.57%
1/175 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.68%
1/147 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Infections and infestations
Tracheitis
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Investigations
Troponin I increased
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
2/176 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.1%
2/175 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.4%
2/147 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 4 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Nervous system disorders
Cerebral haematoma
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Nervous system disorders
Dizziness
|
0.57%
1/176 • Number of events 5 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Nervous system disorders
Headache
|
1.1%
2/176 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.57%
1/175 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.68%
1/147 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/193 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Psychiatric disorders
Delirium
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/193 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.57%
1/175 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.68%
1/147 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.67%
1/149 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/176 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/192 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Vascular disorders
Deep vein thrombosis
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/175 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/193 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/192 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
|
Vascular disorders
Hypertension
|
0.57%
1/176 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.57%
1/175 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/149 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.00%
0/147 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
0.52%
1/193 • Number of events 1 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
1.0%
2/192 • Number of events 2 • 90 Days
Serious and Non-Serious AEs include data for all countries. Results data includes data from NCT05593770.
|
Additional Information
Sean P. Collins, MD
Vanderbilt University Medical Center
Phone: 615-343-8010
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place