The COVID-RASi Trial (COVID-19)

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The COVID-RASi study is an international randomized clinical trial that will evaluate the potential benefit of angiotensin modulators on clinical outcomes, in COVID-19 patients who are at high-risk for cardiovascular disease. The purpose of this study is to determine if renin-angiotensin system inhibitors (RASi), with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), has a beneficial effect in high-risk older patients with COVID-19 infections, by reducing ICU admission, ventilator requirement or death. We would also like to determine if there are differences between ACEi and ARB therapeutic treatments.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Treatments: Angiotensin II; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Angiotensinogen; Enzyme Inhibitors; Giapreza

Criteria

Inclusion Criteria:

• Patient with COVID-19 diagnosis with laboratory confirmation within the last 30 days AND

• Age 65 years old or greater if outpatient OR age over 40 years old if inpatient (admitted to the hospital) at time of recruitment

Exclusion Criteria:

• Contraindication to ARB or ACEi, including severe aortic stenosis and angioedema

• Patients who are currently on active treatment with ARB/ACEi

• Known bilateral renal artery stenosis

• Systolic BP ≤90 mmHg

• eGFR<30 ml/min, if not receiving dialysis treatment

• K>5.5 mmol/L on screening laboratory testing

• Recent history of dizziness, vertigo, or orthostatic hypotension

• Acute respiratory distress syndrome requiring invasive ventilation