Trial Outcomes & Findings for Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE (NCT NCT04505774)
NCT ID: NCT04505774
Last Updated: 2024-12-30
Results Overview
which is defined as the number of days that a patient is alive and free of organ support through the first 21 days after trial entry. Organ Support is defined as receipt of non-invasive mechanical ventilation, high flow nasal canula oxygen, mechanical ventilation, or vasopressor therapy, with death at any time during the index hospitalization assigned -1 days. This outcome variable was designed to exceed day 21 on the IQR. It goes above 21 days because it include baseline day 0 in their design.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
3591 participants
Primary outcome timeframe
21 days from study enrollment
Results posted on
2024-12-30
Participant Flow
Participant milestones
| Measure |
Therapeutic Dose Anticoagulation
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
Standard of care control for the SLGT2 group
|
Standard of Care + Crizanlizumab
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
Standard of care control for the Criza group
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
569
|
514
|
772
|
739
|
287
|
288
|
211
|
211
|
|
Overall Study
COMPLETED
|
565
|
511
|
766
|
735
|
280
|
287
|
210
|
209
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
6
|
4
|
7
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE
Baseline characteristics by cohort
| Measure |
Therapeutic Dose Anticoagulation
n=569 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=514 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=772 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=739 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=287 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=288 Participants
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
|
Standard of Care + Crizanlizumab
n=211 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=211 Participants
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
|
Total
n=3591 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
336 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
575 Participants
n=5 Participants
|
559 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
61 Participants
n=24 Participants
|
2045 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
233 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
230 Participants
n=21 Participants
|
213 Participants
n=8 Participants
|
129 Participants
n=8 Participants
|
150 Participants
n=24 Participants
|
1544 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
232 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
283 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
123 Participants
n=8 Participants
|
80 Participants
n=8 Participants
|
90 Participants
n=24 Participants
|
1444 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
337 Participants
n=5 Participants
|
292 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
456 Participants
n=4 Participants
|
168 Participants
n=21 Participants
|
165 Participants
n=8 Participants
|
131 Participants
n=8 Participants
|
121 Participants
n=24 Participants
|
2147 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
54 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
144 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
136 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
48 Participants
n=24 Participants
|
720 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
292 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
455 Participants
n=5 Participants
|
425 Participants
n=4 Participants
|
210 Participants
n=21 Participants
|
201 Participants
n=8 Participants
|
111 Participants
n=8 Participants
|
120 Participants
n=24 Participants
|
2096 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
102 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
540 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
504 participants
n=5 Participants
|
450 participants
n=7 Participants
|
574 participants
n=5 Participants
|
541 participants
n=4 Participants
|
217 participants
n=21 Participants
|
219 participants
n=8 Participants
|
211 participants
n=8 Participants
|
211 participants
n=24 Participants
|
2927 participants
n=42 Participants
|
|
Region of Enrollment
Brazil
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
88 participants
n=5 Participants
|
90 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
183 participants
n=42 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
19 participants
n=5 Participants
|
18 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
41 participants
n=42 Participants
|
|
Region of Enrollment
Spain
|
65 participants
n=5 Participants
|
64 participants
n=7 Participants
|
89 participants
n=5 Participants
|
86 participants
n=4 Participants
|
63 participants
n=21 Participants
|
63 participants
n=8 Participants
|
00 participants
n=8 Participants
|
0 participants
n=24 Participants
|
430 participants
n=42 Participants
|
|
Region of Enrollment
Mexico
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
10 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 21 days from study enrollmentwhich is defined as the number of days that a patient is alive and free of organ support through the first 21 days after trial entry. Organ Support is defined as receipt of non-invasive mechanical ventilation, high flow nasal canula oxygen, mechanical ventilation, or vasopressor therapy, with death at any time during the index hospitalization assigned -1 days. This outcome variable was designed to exceed day 21 on the IQR. It goes above 21 days because it include baseline day 0 in their design.
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=447 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=462 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=768 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=737 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=285 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=288 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=211 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=210 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
21 Day Organ Support (Respiratory or Vasopressor) Free Days
|
22 days
Interval 18.0 to 22.0
|
22 days
Interval 17.0 to 22.0
|
17 days
Interval 1.0 to 21.0
|
17 days
Interval 0.0 to 21.0
|
22 days
Interval 22.0 to 22.0
|
22 days
Interval 22.0 to 22.0
|
22 days
Interval 22.0 to 22.0
|
22 days
Interval 22.0 to 22.0
|
SECONDARY outcome
Timeframe: 28 days from enrollmentPopulation: Numbers are different from participant flow due to missing data.
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=450 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=463 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=772 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=739 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=287 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=288 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=211 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=211 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Death Within 28 Days
|
39 Participants
|
52 Participants
|
120 Participants
|
114 Participants
|
37 Participants
|
42 Participants
|
23 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 90 days from enrollmentPopulation: Analysis was not completed on the Theraputic Dose Anticoagulation or the Prophylactic Dose Anticogulation arms due to not being collected in this protocol. Numbers are different from participant flow due to missing data.
Acute Kidney Injury Acute kidney injury after enrollment is defined by KDIGO criteria for Acute Kidney Injury in the setting of not meeting these criteria upon enrollment: Modified Stages: ∙ Stage 2: Serum Cr 2.0-2.9 times baseline ∙ Stage 3: Serum Cr ≥ 3.0 times baseline, OR Increase in serum creatinine to ≥ 4.0mg/dl, OR Initiation of renal replacement therapy
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=760 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=733 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=287 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=286 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=188 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=198 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Acute Kidney Injury
|
0 Participants
|
0 Participants
|
38 Participants
|
36 Participants
|
5 Participants
|
5 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Numbers are different from participant flow due to missing data.
A composite endpoint of death, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke during hospitalization or at 28 days after enrollment (whichever is earlier) - "major thrombotic events or death"
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=450 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=463 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=772 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=739 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=287 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=288 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=211 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=211 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Major Thrombotic Event or in Hospital Death
|
450 Participants
|
462 Participants
|
174 Participants
|
177 Participants
|
28 Participants
|
33 Participants
|
32 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Numbers are different from participant flow due to missing data.
A composite endpoint of death, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, DVT, or ischemic stroke during hospitalization or at 28 days after enrollment (whichever is earlier)
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=450 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=463 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=772 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=739 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=287 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=288 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=211 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=211 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Any Thrombotic Event or in Hospital Death
|
450 Participants
|
463 Participants
|
187 Participants
|
177 Participants
|
28 Participants
|
33 Participants
|
32 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Numbers are different from participant flow due to missing data.
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=450 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=463 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=760 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=733 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=287 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=286 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=188 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=198 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Any Renal Replacement Therapy
|
12 Participants
|
12 Participants
|
37 Participants
|
36 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Numbers are different from participant flow due to missing data.
This outcome variable was designed to exceed day 28 on the IQR. It goes above 28 days because it include baseline day 0 in their design.
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=447 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=462 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=768 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=737 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=285 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=288 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=211 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=210 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Days Free of Organ Support and Renal Replacement Therapy
|
29 days
Interval 25.0 to 29.0
|
29 days
Interval 24.0 to 29.0
|
24 days
Interval 8.0 to 29.0
|
24 days
Interval 2.0 to 29.0
|
29 days
Interval 29.0 to 29.0
|
29 days
Interval 29.0 to 29.0
|
29 days
Interval 29.0 to 29.0
|
29 days
Interval 29.0 to 29.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Numbers are different from participant flow due to missing data.
This outcome variable was designed to exceed day 28 on the IQR. It goes above 28 days because it include baseline day 0 in their design.
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=447 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=462 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=768 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=737 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=285 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=288 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=211 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=210 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Ventilator Free Days up to Day 28
|
24.89 days
Interval 29.0 to 29.0
|
24.63 days
Interval 29.0 to 29.0
|
21.09 days
Interval 14.0 to 29.0
|
20.83 days
Interval 10.0 to 29.0
|
26.22 days
Interval 29.0 to 29.0
|
26.42 days
Interval 29.0 to 29.0
|
25.32 days
Interval 29.0 to 29.0
|
26.69 days
Interval 29.0 to 29.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Numbers are different from participant flow due to missing data.
This outcome variable was designed to exceed day 28 on the IQR. It goes above 28 days because it include baseline day 0 in their design.
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=447 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=462 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=768 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=737 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=285 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=288 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=211 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=210 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Days Free of Vasopressors
|
29 days
Interval 29.0 to 29.0
|
29 days
Interval 29.0 to 29.0
|
29 days
Interval 26.0 to 29.0
|
29 days
Interval 25.0 to 29.0
|
29 days
Interval 29.0 to 29.0
|
29 days
Interval 29.0 to 29.0
|
29 days
Interval 29.0 to 29.0
|
29 days
Interval 29.0 to 29.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Numbers are different from participant flow due to missing data.
analysis completed on the Heparin protocol
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=450 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=463 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=770 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=737 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=280 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=283 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=210 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=205 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Progression to Intubation or Death
|
450 Participants
|
463 Participants
|
768 Participants
|
735 Participants
|
273 Participants
|
278 Participants
|
209 Participants
|
199 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Numbers are different from participant flow due to missing data.
Outcome measures
| Measure |
Therapeutic Dose Anticoagulation
n=450 Participants
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=463 Participants
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=772 Participants
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=739 Participants
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=287 Participants
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (SGLT2)
n=288 Participants
Standard of care for the SGLT2 randomizations
|
Standard of Care + Crizanlizumab
n=211 Participants
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=211 Participants
Standard of care for the criza randomizations
|
|---|---|---|---|---|---|---|---|---|
|
Survival Until Discharge
|
406 Participants
|
409 Participants
|
633 Participants
|
598 Participants
|
264 Participants
|
266 Participants
|
186 Participants
|
197 Participants
|
Adverse Events
Therapeutic Dose Anticoagulation
Serious events: 46 serious events
Other events: 0 other events
Deaths: 69 deaths
Prophylactic Dose Anticoagulation
Serious events: 57 serious events
Other events: 0 other events
Deaths: 65 deaths
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
Serious events: 151 serious events
Other events: 0 other events
Deaths: 147 deaths
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
Serious events: 133 serious events
Other events: 0 other events
Deaths: 149 deaths
Standard of Care + SGLT2 Inhibitor
Serious events: 20 serious events
Other events: 0 other events
Deaths: 37 deaths
Standard of Care (sglt2)
Serious events: 33 serious events
Other events: 0 other events
Deaths: 42 deaths
Standard of Care + Crizanlizumab
Serious events: 24 serious events
Other events: 0 other events
Deaths: 37 deaths
Standard of Care (Criza)
Serious events: 28 serious events
Other events: 0 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Therapeutic Dose Anticoagulation
n=569 participants at risk
increased dose of heparin above standard of care.
1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
theraputic heparin: increased dose of heparin above standard of care.
|
Prophylactic Dose Anticoagulation
n=514 participants at risk
Heparin standard of care
1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
prophylactic heparin: standard of care dose of heparin
|
Therapeutic Dose Anticoagulation + P2Y12 Inhibitor
n=772 participants at risk
increased dose of heparin above standard of care with an added P2Y12 inhibitor
This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
theraputic heparin: increased dose of heparin above standard of care.
P2Y12: added P2Y12 inhibitor
|
Prophylactic Dose Anticoagulation + P2Y12 Inhibitor
n=739 participants at risk
Heparin standard of care with an added P2Y12 inhibitor
This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
prophylactic heparin: standard of care dose of heparin
P2Y12: added P2Y12 inhibitor
|
Standard of Care + SGLT2 Inhibitor
n=287 participants at risk
Standard of care plus SGLT2 inhibitor
This arm will enroll moderate and severe illness patients
This arm was ended in March 2023
SGLT2 inhibitor: sglt2 inhibitor
|
Standard of Care (sglt2)
n=288 participants at risk
Standard of care for sglt2 randomzations
This arm will enroll moderate and severe illness patients
|
Standard of Care + Crizanlizumab
n=211 participants at risk
Standard of care plus crizanlizumab infusion
This arm will enroll moderate and severe illness patients
This arm was ended for all patients per the DSMB in September 2022.
Crizanlizumab Injection: crizanlizumab injection
|
Standard of Care (Criza)
n=211 participants at risk
Standard of care for criza randomizations
This arm will enroll moderate and severe illness patients
|
|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Deep Vein Thrombosis
|
0.18%
1/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.39%
2/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.13%
1/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.0%
3/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.47%
1/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.47%
1/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.8%
10/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
3.5%
18/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
5.3%
41/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
3.5%
26/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.70%
2/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.0%
3/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.9%
4/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Cardiac disorders
myocardial infarction
|
0.35%
2/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.39%
2/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.91%
7/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.54%
4/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.35%
1/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.95%
2/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.47%
1/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Vascular disorders
ischemmic stroke
|
0.53%
3/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.58%
3/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.4%
11/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.41%
3/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.35%
1/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Vascular disorders
Other arterial or venous thromboembolism event
|
0.18%
1/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.35%
1/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Vascular disorders
disseminated intravascular coagulation
|
0.00%
0/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.58%
3/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Vascular disorders
symptomatic intracranial or intracerebral hemorrhage
|
0.00%
0/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.14%
1/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Vascular disorders
major bleeding
|
2.3%
13/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.6%
8/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
2.7%
21/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
2.3%
17/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.4%
4/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.0%
3/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
2.8%
6/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.9%
4/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Injury, poisoning and procedural complications
heparin induced thrombocytopenia
|
0.35%
2/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.58%
3/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.39%
3/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.41%
3/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Renal and urinary disorders
diabetic ketoacidosis
|
0.00%
0/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.39%
3/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.4%
4/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
2.4%
7/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
4.3%
9/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
4.7%
10/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
anaphylaxis
|
0.00%
0/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
0.00%
0/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Injury, poisoning and procedural complications
other
|
0.35%
2/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.58%
3/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
3.1%
24/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
4.6%
34/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
3.1%
9/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
2.8%
8/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.9%
4/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.47%
1/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Vascular disorders
arterial thromboembolic event
|
0.35%
2/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.39%
2/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.27%
2/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.35%
1/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.00%
0/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.95%
2/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
|
Vascular disorders
Venus thrombosis
|
1.8%
10/569 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
2.7%
14/514 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
6.1%
47/772 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
6.4%
47/739 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
0.35%
1/287 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.7%
5/288 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
1.9%
4/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
2.8%
6/211 • Discharge, Death or Day 28
Non Serious adverse events were not collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place