Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1155 participants
INTERVENTIONAL
2021-01-27
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No Treatment (Standard of Care)
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.
No interventions assigned to this group
ACEi treatment
The physician will initiate any ACE inhibitor and dose at their discretion.
Angiotensin converting enzyme inhibitor
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.
ARB treatment
The physician will initiate any ARB and dose at their discretion.
Angiotensin II Receptor Blockers
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.
Interventions
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Angiotensin converting enzyme inhibitor
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
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
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Principal Investigators
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Peter Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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Centro de Pesquisa Clinicas Dr Marco Mota
Maceió, Alagoas, Brazil
Centro de Pesquisas em Diabetes e Doencas Endocrino-Metabolicas
Fortaleza, Ceará, 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, Brazil
Hospital Agamenom Magalhaes
Recife, Pernambuco, Brazil
Pronto Socorro Cardiologico de Pernambuco Recife
Recife, Pernambuco, Brazil
Hospital Eduardo Campos da Pessoa Idosa
Estância, Recife, 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, Brazil
Hospital Universitario Sao Francisco na Providencia de Deus
Bragança Paulista, São Paulo, 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, 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, Mexico
Hospital General de Zona 20
La Margarita, Puebla, Mexico
Hospital General Regional No 2
El Marqués, Querétaro, Mexico
Unidad de Medicina Familiar No 77
Ecatepec de Morelos, State of Mexico, Mexico
Hospital General zona 11
Xalapa, Veracruz, Mexico
Unidad de Medicina Familiar No 10
Xalapa, Veracruz, Mexico
Hospital General 1, IMSS
Mexico City, , Mexico
Hospital General de zona 27- IMSS
Mexico City, , Mexico
Countries
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Other Identifiers
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CTO-3212
Identifier Type: -
Identifier Source: org_study_id
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