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NCT Number: NCT04591210

The COVID-RASi Trial (COVID-19)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Pesquisa Clinicas Dr Marco Mota, Maceió, Alagoas, Brazil

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About this study

The goal is to determine if RASi with ACEi or ARB, has a beneficial effect in patients with COVID-19 infections, by reducing hospitalizations, ICU admission, ventilator requirement or death.

This is a multi-centre study, conducted in major centres treating COVID-19 patients in-hospital and in various outpatient settings.

Patients admitted to hospital or outpatients that test positive for COVID-19 and meet the inclusion/exclusion criteria will be eligible to participate in this study. All study participants will not be on RASi (ACEi/ARB) treatment at the time of consent. Participants will be randomized to initiation of ACEi vs ARB treatment vs no RASi treatment as part of care for COVID-19 in a 1:1:1 ratio.

The patient will be followed by their physician according to usual clinical care. Sites will complete research-related follow-ups at 24 hours, 7 and 28 days to asssess patient's clinical status, side effects and the achievement of clinical endpoints by telephone interviews. Phone call follow ups will also be conducted at 6 months and 12 months after enrollment in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with COVID-19 diagnosis with laboratory confirmation within the last 30 days AND
  • Age 40 years old or greater if outpatient OR age 18 years old or greater 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, related to hypotension or orthostatic hypotension, that can lead to contraindication to ACEI/ARBs
  • Acute respiratory distress syndrome requiring invasive ventilation

Treatment and study plan

Angiotensin Converting Enzyme Inhibitor

Drug

The study recommends physicians to select an ACEi with proven benefit in cardiovascular diseases such as perindopril, ramipril or enalapril. Lab values will be obtained during baseline. The patient will be followed by the physician clinically, with recommended laboratory testing in one week, including renal function, potassium assessment, and dose adjustments as appropriate.

Angiotensin II Receptor Blockers

Drug

The study recommends physicians to select evidence-based ARBs such as candesartan or valsartan or losartan. Lab values will be obtained during baseline. The patient will be followed by the physician clinically, with recommended laboratory testing in one week, and dose adjustments as appropriate.

Primary outcomes

  1. Death

    Time frame: 28 days

    Within first 28 days post randomization

  2. Mechanical ventilation

    Time frame: 28 days

    Within first 28 days post randomization

  3. ICU admission

    Time frame: 28 days

    Within first 28 days post randomization

  4. Major Adverse Cardiac Events (MACE)

    Time frame: 28 days

    Within first 28 days post randomization

  5. Hospitalizations

    Time frame: 28 days

    Within first 28 days post randomization

  6. Quality of life of study participants

    Time frame: 1 year

    Assessed by ongoing symptoms and standardized questionnaires, scale to assess overall health 1-100, 100 is the best, higher score means better outcome

  7. Quality of life of study participants

    Time frame: 1 year

    Assessed by ongoing symptoms and standardized questionnaires- scale to assess overall health 1-100, 100 is the best, higher score means better outcome

Secondary outcomes

  1. Days alive and out of hospital

    Time frame: 30 days

  2. Days alive and out of hospital

    Time frame: 180 days

  3. Cardiovascular mortality

    Time frame: 1 year

  4. All cause hospitalization

    Time frame: 1 year

  5. Percent of patients require intensive care

    Time frame: 1 year

  6. Percent of patients requiring ventilation

    Time frame: 1 year

  7. Percent of patients requiring dialysis

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

Evaluation of the Potential Benefit of Renin-angiotensin System Inhibitors (RASi, ACEi/ARB) in High-risk Patients With COVID-19. The COVID-RASi Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2020
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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