Status:
COMPLETED
RAS and Coagulopathy in COVID19
Lead Sponsor:
Imperial College London
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
To determine whether the coagulopathy associated with COVID-19 infection is driven by overactivation of the renin angiotensin system (RAS)
Detailed Description
The proposed study will be run as a double-blind, randomized controlled experimental medicine study in male and female hospitalised (n=60) aged 18 or over, with confirmed COVID-19 infection. Patients ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04419610
Start Date
October 9 2020
End Date
May 12 2021
Last Update
May 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Imperial College NHS Trust
London, United Kingdom, W12 0HS