Overview

The Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY) study is a pragmatic prospective, open-label, randomised controlled trial. CLARITY aims to examine the effectiveness of angiotensin II receptor blockers (ARBs) on improving the outcomes of people who tested positive for COVID-19 disease.

Eligibility

Inclusion Criteria:

Potential participants must satisfy all of the following:

1. Laboratory-confirmed diagnosis of SARS-CoV-2 infection
2. Age 18 years
3. a) Systolic Blood Pressure (SBP) 125 mmHg OR b) SBP 115 mmHg and currently treated with a non-RAASi Blood Pressure (BP) lowering agent that can be ceased
4. Participant and treating staff are willing and able to perform trial procedures.
5. Either Intended for hospital admission for management of COVID-19, or

Intended for management at home with one or more of the following criteria:

1. Age60 years
2. BMI 30kg/m2 (derived from the patient's self report of their height and weight where these are not measured directly)
3. Diagnosis of diabetes with HbA1c 7% or on glucose lowering medication
4. History of cardiovascular disease
5. History of chronic respiratory illness
6. Currently treated with immunosuppression
7. a) For those intended for hospital admission, the diagnosis (i.e. date of test result) for SARS-CoV-2 infection must be within 3 days prior to randomisation, OR b) For those intended for management at home, the diagnosis (i.e. date of test result) for SARS-CoV-2 infection must be within 7 days prior to randomisation

Exclusion Criteria:

1. Currently treated with an ACEi, ARB or aldosterone antagonist, aliskeren, or angiotensin receptor-neprilysin inhibitors (ARNi)
2. Serum potassium > 5.2 mmol/L or no potassium testing within the last 3 months
3. a) For those intended for hospital admission, an estimated Glomerular Filtration Rate (eGFR) <30ml/min/1.732 or no eGFR testing within the last 3 months, OR b) For those intended for management at home, an eGFR <45ml/min/1.732 or no eGFR testing within the last 3 months
4. Known symptomatic postural hypotension
5. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15) - see Table below
6. Intolerance of ARB
7. Women younger than 51 years who have not had a negative pregnancy test during the past 3 days
8. Women younger than 51 years who do not agree to use adequate contraception
9. Women who are currently breastfeeding
10. 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