Early Phase 1
N=28
RAS and Coagulopathy in COVID19
COVID
Bottom Line
View on ClinicalTrials.gov: NCT04419610 ↗Enrolled (actual)
28
Serious AEs
28.6%
Results posted
May 2024
Primary outcome: Primary: Coagulopathy Associated With COVID-19 — -313; -129.5 ng/mL FEU
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- TRV027 (Biological); sodium chloride 0.9% (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coagulopathy Associated With COVID-19 |
-313; -129.5 | — |
| SECONDARY Markers of Dysregulation of Coagulation System |
52.5; -14 | — |
| SECONDARY Markers of Dysregulation of Coagulation System Change From Baseline |
-1.3; -0.5 | — |
| SECONDARY Markers of Dysregulation of Coagulation System |
52.5; -14 | — |
| SECONDARY Markers of Dysregulation of Coagulation System |
52.5; -14 | — |
| SECONDARY Markers of Dysregulation of Coagulation System |
52.5; -14 | — |
| SECONDARY Markers of Dysregulation of RAS |
0; -0.9 | — |
| SECONDARY Markers of Haemolysis/Inflammation |
0; 0.13 | — |
| SECONDARY Markers of Haemolysis/Inflammation |
0; 0.13 | — |
| SECONDARY Markers of Haemolysis/Inflammation |
0; 0.13 | — |
| SECONDARY Markers of Inflammation (Bacterial Sepsis) |
0; 0 | — |
| SECONDARY Markers of Organ Dysregulation - Kidney |
-4; -5 | — |
| SECONDARY Markers of Dysregulation of Cardiovascular System |
-2.5; -2.5 | — |
| SECONDARY Markers of Dysregulation of Cardiovascular System |
-2.5; -2.5 | — |
| SECONDARY Marker of Dysregulation of Endocrine System |
-1.1; -0.00 | — |
Summary
To determine whether the coagulopathy associated with COVID-19 infection is driven by overactivation of the renin angiotensin system (RAS)
Eligibility Criteria
INCLUSION CRITERIA
A subject will be eligible for inclusion in this study only if all of the following criteria apply at the time of screening:
- Hospitalised with confirmed COVID-19 infection.
- Screened within 96hrs of SARS-COV-2 positive PCR.
- Age 18 or over
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Systolic blood pressure between 100 and 180
EXCLUSION CRITERIA
A subject will not be eligible for inclusion in this study if any of the following criteria apply at the time of screening:
- Any unrelated clinical condition, which, in the opinion of the investigator, may affect D-dimer during the course of the study, independent of COVID-19 infection, e.g. subsets of cancers and coagulopathies.
- Concomitant medication which inhibit the action of TRV027 (ARB's).
- Any clinically significant medical conditions that in the opinion of the investigator would compromise subjects' safety or compliance with study procedures.
- Any clinical condition which in the opinion of the principal investigator would compromise the scientific integrity of the study
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT04419610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.