COVID Clinical Trial
Official title:
Investigating the Relationship Between the Renin Angiotensin System and the Coagulopathy Associated With COVID-19
Verified date | May 2024 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine whether the coagulopathy associated with COVID-19 infection is driven by overactivation of the renin angiotensin system (RAS)
Status | Completed |
Enrollment | 28 |
Est. completion date | May 12, 2021 |
Est. primary completion date | May 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: 1. Hospitalised with confirmed COVID-19 infection. 2. Screened within 96hrs of SARS-COV-2 positive PCR. 3. Age 18 or over 4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 5. 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: 1. 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. 2. Concomitant medication which inhibit the action of TRV027 (ARB's). 3. Any clinically significant medical conditions that in the opinion of the investigator would compromise subjects' safety or compliance with study procedures. 4. Any clinical condition which in the opinion of the principal investigator would compromise the scientific integrity of the study 5. Unwillingness or inability to follow the procedures outlined in the protocol. 6. Subject is pregnant or breastfeeding |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Robbins AJ, Che Bakri NA, Toke-Bjolgerud E, Edwards A, Vikraman A, Michalsky C, Fossler M, Lemm NM, Medhipour S, Budd W, Gravani A, Hurley L, Kapil V, Jackson A, Lonsdale D, Latham V, Laffan M, Chapman N, Cooper N, Szydlo R, Boyle J, Pollock KM, Owen D. T — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coagulopathy Associated With COVID-19 | Change from Day 1 (Baseline) in D-dimer Levels at Day 3 | Day 1 (baseline) and Day 3). | |
Secondary | Markers of Dysregulation of Coagulation System | Change from Day 1 (Baseline) in platelet count Levels at Day 3 (10E9 platelets/L) | Day 1 (baseline) and Day 3 | |
Secondary | Markers of Dysregulation of Coagulation System Change From Baseline | Activated Partial Thromboplastin Time (aPTT) - Change from Baseline (day 1) to Day 3 | Baseline (Day 1) to Day 3 | |
Secondary | Markers of Dysregulation of Coagulation System | INR - Change from Baseline (day 1) to Day 3:
INR (International Normalised Ratio) |
Baseline (day 1) to Day 3 | |
Secondary | Markers of Dysregulation of Coagulation System | fibrinogen (g/L) -Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Markers of Dysregulation of Coagulation System | Ferritin Ug/mL -Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Markers of Dysregulation of RAS | Plasma Renin activity (nmol/L/h) -Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Markers of Haemolysis/Inflammation | Total bilirubin (umol/L) -Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Markers of Haemolysis/Inflammation | LDH u/L -Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Markers of Haemolysis/Inflammation | Haptoglobin g/L - Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Markers of Inflammation (Bacterial Sepsis) | Pro-calcitonin ug/L - Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Markers of Organ Dysregulation - Kidney | Creatinine (umol/L) - Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Markers of Dysregulation of Cardiovascular System | BNP (B-type natriuetic Peptide) ng/L - Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Markers of Dysregulation of Cardiovascular System | Troponin ng/L - Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 | |
Secondary | Marker of Dysregulation of Endocrine System | glucose mmol/L - Change from Baseline (day 1) to Day 3 | Baseline (day 1) to Day 3 |
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