Trial Outcomes & Findings for RAS and Coagulopathy in COVID19 (NCT NCT04419610)
NCT ID: NCT04419610
Last Updated: 2024-05-03
Results Overview
Change from Day 1 (Baseline) in D-dimer Levels at Day 3
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Day 1 (baseline) and Day 3).
Results posted on
2024-05-03
Participant Flow
Participant milestones
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
13
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
discharged early
|
1
|
1
|
Baseline Characteristics
RAS and Coagulopathy in COVID19
Baseline characteristics by cohort
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=15 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=13 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=93 Participants
|
70 years
n=4 Participants
|
68.5 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
white
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1 (baseline) and Day 3).Population: Incomplete analysis set
Change from Day 1 (Baseline) in D-dimer Levels at Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Coagulopathy Associated With COVID-19
|
-313 ng/mL FEU
Interval -1253.0 to 822.0
|
-129.5 ng/mL FEU
Interval -365.0 to 710.0
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 3Change from Day 1 (Baseline) in platelet count Levels at Day 3 (10E9 platelets/L)
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Dysregulation of Coagulation System
|
25 10E9 platelets/L
Interval -12.0 to 129.0
|
28.5 10E9 platelets/L
Interval -113.0 to 107.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 3Activated Partial Thromboplastin Time (aPTT) - Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Dysregulation of Coagulation System Change From Baseline
|
-1.3 SECONDS
Interval -5.2 to 2.3
|
-0.5 SECONDS
Interval -4.8 to 2.7
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3INR - Change from Baseline (day 1) to Day 3: INR (International Normalised Ratio)
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Dysregulation of Coagulation System
|
1.25 Unitless RATIO
Interval -1.6 to 3.6
|
0 Unitless RATIO
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3fibrinogen (g/L) -Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Dysregulation of Coagulation System
|
-0.67 g/L
Interval -2.8 to 1.68
|
-0.94 g/L
Interval -1.81 to 2.11
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3Ferritin Ug/mL -Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Dysregulation of Coagulation System
|
52.5 ug/L
Interval -324.0 to 838.0
|
-14 ug/L
Interval -572.0 to 886.0
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3Plasma Renin activity (nmol/L/h) -Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Dysregulation of RAS
|
0 NMOL/L/h
Interval 0.0 to 0.0
|
-0.9 NMOL/L/h
Interval -3.3 to 0.1
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3Total bilirubin (umol/L) -Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Haemolysis/Inflammation
|
-0.5 UMOL/L
Interval -4.0 to 2.0
|
0 UMOL/L
Interval -4.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3LDH u/L -Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Haemolysis/Inflammation
|
-17 u/L
Interval -217.0 to 270.0
|
1 u/L
Interval -151.0 to 102.0
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3Haptoglobin g/L - Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Haemolysis/Inflammation
|
0 g/L
Interval -1.09 to 0.08
|
0.13 g/L
Interval 0.0 to 0.74
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3Pro-calcitonin ug/L - Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Inflammation (Bacterial Sepsis)
|
0 ug/L
Interval -0.03 to 0.16
|
0 ug/L
Interval -1.12 to 0.03
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3Creatinine (umol/L) - Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Organ Dysregulation - Kidney
|
-4 UMOL/L
Interval -16.0 to 11.0
|
-5 UMOL/L
Interval -14.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3BNP (B-type natriuetic Peptide) ng/L - Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Dysregulation of Cardiovascular System
|
60 ng/L
Interval -5.0 to 762.0
|
-19 ng/L
Interval -66.0 to 62.0
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3Troponin ng/L - Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Markers of Dysregulation of Cardiovascular System
|
-2.5 ng/L
Interval -50.0 to 0.0
|
-2.5 ng/L
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline (day 1) to Day 3glucose mmol/L - Change from Baseline (day 1) to Day 3
Outcome measures
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=11 Participants
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=10 Participants
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Marker of Dysregulation of Endocrine System
|
-1.1 mmol/L
Interval -2.0 to 0.1
|
-0.00 mmol/L
Interval -4.7 to 3.8
|
Adverse Events
Patients With Confirmed/Suspected C19 Given Intervention
Serious events: 5 serious events
Other events: 3 other events
Deaths: 2 deaths
Patients With Confirmed/Suspected C19 Given no Intervention
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=15 participants at risk
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=13 participants at risk
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
severe COVID 19 pneumonia
|
13.3%
2/15 • Number of events 2 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
7.7%
1/13 • Number of events 1 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
|
Nervous system disorders
confusion
|
6.7%
1/15 • Number of events 1 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
0.00%
0/13 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
6.7%
1/15 • Number of events 1 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
7.7%
1/13 • Number of events 1 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/15 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
7.7%
1/13 • Number of events 1 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
0.00%
0/13 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
Other adverse events
| Measure |
Patients With Confirmed/Suspected C19 Given Intervention
n=15 participants at risk
Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).
TRV027: peptide for infusion
|
Patients With Confirmed/Suspected C19 Given no Intervention
n=13 participants at risk
Saline infusion.
sodium chloride 0.9%: placebo comparator for infusion
|
|---|---|---|
|
Infections and infestations
Infection
|
13.3%
2/15 • Number of events 2 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
7.7%
1/13 • Number of events 1 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
|
Blood and lymphatic system disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
0.00%
0/13 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
|
Surgical and medical procedures
injection site reaction
|
0.00%
0/15 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
7.7%
1/13 • Number of events 1 • Day 1 to day 7 and day 30 - 7 days of infused drug and follow up call on day 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place