COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44605

Professor Vivekanand Jha

vjha@georgeinstitute.org.in

2020-07-27

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Potential participants must meet all of the following: <br/ >1. Laboratory-confirmed diagnosis of SARS-CoV-2 infection <br/ >a. Confirmation through appropriate approved laboratory or Point of Care testing method, <br/ >including Polymerase Chain Reaction or other public health assay. <br/ >2. Age greater than or equal to 18 years <br/ >3. Either <br/ >a. Systolic BP (SBP) greater than or equal to 125mmHg <br/ >OR <br/ >b. SBP greater than or equal to 115mmHg and currently treated with a non-RAS inhibitor (RASi) BP-lowering agent <br/ >that can be ceased <br/ >4. Participant and treating staff are willing and able to perform trial procedures. <br/ >5. Intended for admission to a participating hospital for management of COVID-19 <br/ >6. Diagnosis (i.e. date of test result) for SARS-CoV-2 infection must be within 3 days prior to <br/ >randomisation <br/ >

Potential participants must not meet any of the following: <br/ >1. Currently treated with an ACEI, ARB or aldosterone antagonist, aliskiren, or angiotensin receptor neprilysin inhibitors (ARNi) <br/ >2.Serum potassium >5.2 mmol/L or no potassium testing within the last 3 months <br/ >3. Estimated Glomerular Filtration Rate (eGFR) less than 30ml/min/1.73m2 or no eGFR testing within the last 3 months, or <br/ >4. Known symptomatic postural hypotension <br/ >5. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15) <br/ >6. Intolerance of ARB <br/ >7. Women <51 years who are pregnant, have a positive bHCG or are currently breastfeeding <br/ >8. Individuals who are not able to take medications by mouth at enrolment, or who are not expected to be able to take medications by mouth during the first 48 hours after randomisation <br/ >

2

George Institute for Global Health India

18

99

India

No restriction on type of patients

0: No restriction on type of patients

605

The primary endpoint is a 7-point NIH Coronavirus Disease 2019 (COVID-19) score; a <br/ >modified version of the 9-point score developed by the WHO for COVID-19 trials. <br/ >Timepoint: The <br/ >ordinal scale is an assessment of the clinical status of the participant at the first <br/ >assessment for the day; measured at Day 28. <br/ >

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 86, "treatment_name": "Angiotensin receptor blocker (arb)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]