Controlled evaluation of Angiotensin Receptor Blockers for COVID-19Respiratory Disease

Phase 3

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/07/026831
• Lead Sponsor: George Institute for Global Health India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-14
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 778

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

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 <51 years who are pregnant, have a positive bHCG or are currently breastfeeding

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified