NCT04394117

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 787 (actual)
• Sponsor: The George Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronavirus Disease 2019
• COVID-19

Interventions

Type	Name	Description
DRUG	Angiotensin Receptor Blockers	Angiotensin Receptor Blockers (ARBs) have been in clinical use for more than 30 years for their cardiac and renal protective effects. ARBs mechanism of action is through selective inhibition of angiotensin-II (Ang-II) by competitive antagonism of the angiotensin receptor. ARBs displace ang-II from the angiotensin I receptor and produce their protective effects by reducing the downstream effects of ang-II induced vasoconstriction, aldosterone release, catecholamine release, arginine vasopressin release, water intake, and hypertrophic response The virus causing COVID-19, SARS-CoV-2, binds to the extracellular portion of Angiotensin-Converting-Enzyme-2 (ACE2) expressed on type II alveolar cells in the lungs which is followed by internalization of ACE2 before downregulating membrane ACE2 expression. Both these components appear to require angiotensin receptor Type 1 (AT1R), and ARBs, which block the actions of AT1R, would reduce the severity of COVID-19 and reduce the duration of symptoms
OTHER	Placebo	Placebo

Timeline

• Start date: 2020-06-19
• Primary completion: 2021-11-14
• Completion: 2022-01-17
• First posted: 2020-05-19
• Last updated: 2022-03-17

Locations

22 sites across 2 countries: Australia, India