The COVID-RASi Trial (COVID-19)
Evaluation of the Potential Benefit of Renin-angiotensin System Inhibitors (RASi, ACEi/ARB) in High-risk Patients With COVID-19. The COVID-RASi Trial
1 other identifier
interventional
372
3 countries
31
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Jan 2021
Longer than P75 for phase_3 covid19
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
January 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJanuary 28, 2026
January 1, 2026
3.9 years
October 6, 2020
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Death
Within first 28 days post randomization
28 days
Mechanical ventilation
Within first 28 days post randomization
28 days
ICU admission
Within first 28 days post randomization
28 days
Major Adverse Cardiac Events (MACE)
Within first 28 days post randomization
28 days
Hospitalizations
Within first 28 days post randomization
28 days
Quality of life of study participants
Assessed by ongoing symptoms and standardized questionnaires, scale to assess overall health 1-100, 100 is the best, higher score means better outcome
1 year
Quality of life of study participants
Assessed by ongoing symptoms and standardized questionnaires- scale to assess overall health 1-100, 100 is the best, higher score means better outcome
1 year
Secondary Outcomes (7)
Days alive and out of hospital
30 days
Days alive and out of hospital
180 days
Cardiovascular mortality
1 year
All cause hospitalization
1 year
Percent of patients require intensive care
1 year
- +2 more secondary outcomes
Study Arms (3)
No Treatment (Standard of Care)
NO INTERVENTIONParticipants 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.
ACEi treatment
EXPERIMENTALThe physician will initiate any ACE inhibitor and dose at their discretion.
ARB treatment
EXPERIMENTALThe physician will initiate any ARB and dose at their discretion.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Centro de Pesquisa Clinicas Dr Marco Mota
Maceió, Alagoas, Brazil
Centro de Pesquisas em Diabetes e Doencas Endocrino-Metabolicas
Fortaleza, Ceará, 60-430-350, Brazil
Santa Casa de Itabuna
Itabuna, Estado de Bahia, Brazil
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
Centro de Pesquisa Clinica da Unimed Campo Grande
Campo Grande, Minas Gerais, Brazil
Clinica de Campo Grande
Campo Grande, Minas Gerais, Brazil
Nucleo de Pesquisa Clinica SS
Curitiba, Paraná, 80730-150, Brazil
Hospital Agamenom Magalhaes
Recife, Pernambuco, Brazil
Pronto Socorro Cardiologico de Pernambuco Recife
Recife, Pernambuco, Brazil
Hospital Eduardo Campos da Pessoa Idosa
Estância, Recife, 50870-901, Brazil
Instituto Atena de Pesquisa Clinica
Natal, Rio Grande do Norte, Brazil
Hospital Universitar Canoas
Canoas, Rio Grande do Sul, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital Universitario Sao Francisco na Providencia de Deus
Bragança Paulista, São Paulo, 12916-542, Brazil
Instituto de Pesquisa Clinica de Campinas
Campinas, São Paulo, Brazil
Hospital Bela Vista
Consolação, São Paulo, Brazil
Hospital de Julho
São Paulo, São Paulo, 01409-901, Brazil
Instituto de Coracao
São Paulo, São Paulo, Brazil
Instituto Prevent Senior
São Paulo, São Paulo, Brazil
Instituto Goiano de Oncologia e Hematologia
Goiânia, Brazil
Alberta Health Services
Edmonton, Alberta, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Hospital de Infectologia Dr Daniel Mendez Fernandez
Azcapotzalco, Mexico City, 06900, Mexico
Hospital General de Zona 20
La Margarita, Puebla, 72560, Mexico
Hospital General Regional No 2
El Marqués, Querétaro, 76269, Mexico
Unidad de Medicina Familiar No 77
Ecatepec de Morelos, State of Mexico, Mexico
Hospital General zona 11
Xalapa, Veracruz, 91000, Mexico
Unidad de Medicina Familiar No 10
Xalapa, Veracruz, 91000, Mexico
Hospital General 1, IMSS
Mexico City, Mexico
Hospital General de zona 27- IMSS
Mexico City, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Liu, MD
Ottawa Heart Institute Research Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 19, 2020
Study Start
January 27, 2021
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share