Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Standard Care plus Angiotensin Receptor Blockers (ARB): Dose: 20 mg to 80 mg. Frequency : Once daily Route of administration: Oral
Control Intervention1: Standard Care: Standard Care
Sponsors
George Institute for Global Health India
Eligibility
Inclusion criteria
Inclusion criteria: Potential participants must meet all of the following: 1. Laboratory-confirmed diagnosis of SARS-CoV-2 infection a. Confirmation through appropriate approved laboratory or Point of Care testing method, including Polymerase Chain Reaction or other public health assay. 2. Age greater than or equal to 18 years 3. Either a. Systolic BP (SBP) greater than or equal to 125mmHg OR b. SBP greater than or equal to 115mmHg and currently treated with a non-RAS inhibitor (RASi) BP-lowering agent that can be ceased 4. Participant and treating staff are willing and able to perform trial procedures. 5. Intended for admission to a participating hospital for management of COVID-19 6. Diagnosis (i.e. date of test result) for SARS-CoV-2 infection must be within 3 days prior to randomisation
Exclusion criteria
Exclusion criteria: Potential participants must not meet any of the following: 1. Currently treated with an ACEI, ARB or aldosterone antagonist, aliskiren, or angiotensin receptor neprilysin inhibitors (ARNi) 2.Serum potassium >5.2 mmol/L or no potassium testing within the last 3 months 3. Estimated Glomerular Filtration Rate (eGFR) less than 30ml/min/1.73m2 or no eGFR testing within the last 3 months, or 4. Known symptomatic postural hypotension 5. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15) 6. Intolerance of ARB 7. Women 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a 7-point NIH Coronavirus Disease 2019 (COVID-19) score, a modified version of the 9-point score developed by the WHO for COVID-19 trials. Timepoint: The ordinal scale is an assessment of the clinical status of the participant at the first assessment for the day, measured at Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| 7-point ordinal scale scoreTimepoint: At Day 15;Admission to ICUTimepoint: Between baseline and Day 28 Between baseline and Day 90 ;AKI, based on Kidney Disease Improving Global Outcomes definitionTimepoint: At Day 28;Dialysis requirementTimepoint: At Day 28;Hyperkalaemia, defined as more than 6.0mmoL/LTimepoint: At Day 28;Hypotension requiring vasopressorsTimepoint: Between baseline and Day 28;Length of stay in ICUTimepoint: To Day 90;MortalityTimepoint: At Day 28;Number of dialysis daysTimepoint: Between baseline and Day 28;Number of hospitalisation daysTimepoint: Between baseline and Day 28 Between baseline and Day 90;Number of ventilator-free daysTimepoint: Between baseline and Day 28;Oxygen (O2) saturation/Fractional inh-O2Timepoint: At Day 8 and Day 15;Respiratory failure Timepoint: At Day 28 | — |
Countries
India
Contacts
Public ContactProfessor Vivekanand Jha
George Institute for Global Health
Outcome results
None listed