Table 1 Eligibility criteria, according to hospital admission status at time of enrolment
Criteria | Inpatients (India and Australia) | Virtual care patients (Australia only) |
|---|---|---|
Inclusion | ||
Laboratory-confirmed active SARS-CoV-2 infection within 10 days prior to randomisation, using any locally approved testing method | ✓ | ✓ |
Aged ≥ 18 years | ✓ | ✓ |
Be at high risk of severe disease, defined as: | ||
• Requiring hospital admission for the management of COVID-19 or, | ✓ | ❌ |
• Having at least one of the following risk factors for severe disease: - Aged ≥ 60 years - BMI ≥ 30 kg/m2 - Diagnosis of diabetes defined as HbA1c ≥7% and/or use of glucose-lowering medication - History of cardiovascular diseasea - History of chronic respiratory diseasea - Current treatment with immunosuppression | ± | ✓ |
SBP ≥ 120 mmHg, or SBP ≥ 115 mmHg and receiving treatment with a non-RAAS-inhibitor blood pressure-lowering agent that can be ceased | ✓ | ✓ |
Willing and able to perform trial procedures | ✓ | ✓ |
Exclusion | ||
Reduced eGFR in preceding 3 months, defined as < 30 mL/min/1.73m2 or the absence of an eGFR test | ✓ | ❌ |
Reduced eGFR in preceding three months, defined as < 45 mL/min/1.73m2 or the absence of an eGFR test | ❌ | ✓ |
Elevated serum potassium, defined as > 5.2 mmol/L, within the preceding 3 months or the absence of a serum potassium test | ✓ | ✓ |
Receiving treatment with an ACE inhibitor, ARB, aldosterone antagonist, aliskiren or angiotensin receptor neprilysin inhibitor | ✓ | ✓ |
Known intolerance to ARBs | ✓ | ✓ |
Known symptomatic postural hypotension | ✓ | ✓ |
Known biliary obstruction or severe hepatic impairment | ✓ | ✓ |
Inability to take medications by mouth during the first 48 h after randomisation | ✓ | ✓ |
Women who are currently pregnant or breast feeding (India) Or Women < 51 years without a negative pregnancy test during the previous 3 days and/or who do not agree to use adequate contraception during the 28-day treatment period (Australia) | ✓ | ✓ |