Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease

• Status: Active, not recruiting
• Trial end date: 2022-01-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute
• Treatments: Angiotensin Receptor Antagonists; Candesartan; Eprosartan; Irbesartan; Losartan; Olmesartan; Telmisartan; Valsartan

Criteria

Inclusion Criteria:

Potential participants must satisfy all of the following:

1. Laboratory-confirmed* diagnosis of SARS-CoV-2 infection within 10 days prior to randomisation

2. Age ≥ 18 years

3. a) Systolic Blood Pressure (SBP) ≥ 120 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 clinician are willing and able to perform trial procedures.

5. Either Intended for hospital admission for management of COVID-19, or (In Australia Only) Intended for management at home with one or more of the following criteria:

1. Age≥60 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 defined as HbA1c ≥7% and/or the consumption of glucose lowering medication

4. History of cardiovascular disease

5. History of chronic respiratory illness

6. Currently treated with immunosuppression

Exclusion Criteria:

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. For those intended for hospital admission, an estimated Glomerular Filtration Rate (eGFR) <30ml/min/1.73m2 or no eGFR testing within the last 3 months, or For those intended for management at home (Australia only), an eGFR <45ml/min/1.73m2 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. Pregnancy or risk of pregnancy, defined as;

1. (In Australia only) Women younger than 51 years who have not had a negative pregnancy test during the past 3 days and/or who do not agree to use adequate contraception

2. (In India Only) Women who are pregnant

8. Women who are currently breastfeeding

9. 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