Blood Pressure Medications for COVID-19

Palo Alto (17 mi)

Overseen byPeter Liu, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Ottawa Heart Institute Research Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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. 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 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. With the increasing potential of long COVID symptoms, at the 1 year follow up, a primary endpoint will be the quality of life of study participants, as assessed by ongoing symptoms and/or the standardized questionnaires.

Eligibility Criteria

Adults diagnosed with COVID-19 can join this trial. Hospitalized patients must be 18 or older, while non-hospitalized ones need to be at least 40. They should have confirmed COVID-19 within the last month but not suffer from severe low blood pressure, high potassium levels, certain kidney issues, or conditions that make ACEi/ARB use unsafe.

Inclusion Criteria

I am 40 years old or older.

Exclusion Criteria

I have narrowing in the arteries of both my kidneys.

I am currently taking medication for blood pressure.

I cannot take certain blood pressure medicines due to severe heart valve issues or allergic reactions.

I am on a breathing machine due to severe lung problems.

My kidney function is low and I am not on dialysis.

Treatment Details

The study is testing if drugs called RAS inhibitors—specifically ACE inhibitors (ACEi) and Angiotensin II Receptor Blockers (ARB)—can improve outcomes for COVID-19 patients by reducing ICU stays, ventilator needs or death. It also compares the effectiveness of ACEi versus ARB on long-term quality of life.

3Treatment groups

Experimental Treatment

Active Control

Group I: ARB treatmentExperimental Treatment1 Intervention

The physician will initiate any ARB and dose at their discretion.

Group II: ACEi treatmentExperimental Treatment1 Intervention

The physician will initiate any ACE inhibitor and dose at their discretion.

Group III: No Treatment (Standard of Care)Active Control1 Intervention

Participants will be treated as per standardized care pathway according to province/state and institutional guidelines. Physicians will be reminded not to start ACEi or ARB throughout admission or to outpatients until active study participation is complete at 28 days post symptoms.

Angiotensin converting enzyme inhibitor is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as ACE inhibitors for: