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RAS Inhibitor

Blood Pressure Medications for COVID-19

Phase 3

Waitlist Available

Led By Peter Liu, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 40 years old or greater if outpatient

Be older than 18 years old

Must not have

Known bilateral renal artery stenosis

Patients who are currently on active treatment with ARB/ACEi

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test whether drugs that treat high blood pressure can also help treat Covid-19 in high-risk patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include dizziness or lightheadedness due to low blood pressure, elevated potassium levels which can affect heart rhythm, and potential kidney function changes. These medications may not suit those with a history of swelling caused by drug reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have narrowing in the arteries of both my kidneys.

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I am currently taking medication for blood pressure.

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Death

Hospitalizations

ICU admission

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angiotensin II

FDA approved

0 / 6Eligibility criteria met