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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04591210
Other study ID # CTO-3212
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 27, 2021
Est. completion date December 2025

Study information

Verified date February 2024
Source Ottawa Heart Institute Research Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1155
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Brazil Hospital Felicio Rocho Belo Horizonte MG
Brazil Hospital Universitario Sao Francisco na Providencia de Deus Bragança Paulista Sao Paulo
Brazil Instituto de Pesquisa Clinica de Campinas Campinas SP
Brazil Centro de Pesquisa Clinica da Unimed Campo Grande Campo Grande MG
Brazil Clinica de Campo Grande Campo Grande MG
Brazil Hospital Universitar Canoas Canoas RS
Brazil Hospital Bela Vista Consolacao SP
Brazil Nucleo de Pesquisa Clinica SS Curitiba Parana
Brazil Hospital Eduardo Campos da Pessoa Idosa Estancia Recife
Brazil Centro de Pesquisas em Diabetes e Doencas Endocrino-Metabolicas Fortaleza CE
Brazil Instituto Goiano de Oncologia e Hematologia Goiânia
Brazil Santa Casa de Itabuna Itabuna Bahia
Brazil Centro de Pesquisa Clinicas Dr Marco Mota Maceio Alagoas
Brazil Instituto Atena de Pesquisa Clinica Natal RN
Brazil Hospital Sao Vicente de Paulo Passo Fundo RS
Brazil Hospital Sao Lucas da PUCRS Porto Alegre RS
Brazil Hospital Agamenom Magalhaes Recife PE
Brazil Pronto Socorro Cardiologico de Pernambuco Recife Recife PE
Brazil Instituto Prevent Senior Sao Paulo SP
Brazil Hospital de Julho São Paulo SP
Brazil Instituto de Coracao São Paulo SP
Canada Alberta Health Services Edmonton Alberta
Canada University of Ottawa Heart Institute Ottawa Ontario
Mexico Hospital de Infectologia Dr Daniel Mendez Fernandez Azcapotzalco Ciudad De Mexico
Mexico Hospital General 1, IMSS Ciudad de Mexico
Mexico Hospital General de zona 27- IMSS Ciudad de Mexico
Mexico Unidad de Medicina Familiar No 77 Ecatepec de Morelos Estado De Mexico
Mexico Hospital General Regional No 2 El Marques Queretaro
Mexico Hospital General de Zona 20 La Margarita Puebla
Mexico Hospital General zona 11 Xalapa Veracruz
Mexico Unidad de Medicina Familiar No 10 Xalapa Veracruz

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Heart Institute Research Corporation

Countries where clinical trial is conducted

Brazil,  Canada,  Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death Within first 28 days post randomization 28 days
Primary Mechanical ventilation Within first 28 days post randomization 28 days
Primary ICU admission Within first 28 days post randomization 28 days
Primary Major Adverse Cardiac Events (MACE) Within first 28 days post randomization 28 days
Primary Hospitalizations Within first 28 days post randomization 28 days
Primary 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
Primary 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 Days alive and out of hospital 30 days
Secondary Days alive and out of hospital 180 days
Secondary Cardiovascular mortality 1 year
Secondary All cause hospitalization 1 year
Secondary Percent of patients require intensive care 1 year
Secondary Percent of patients requiring ventilation 1 year
Secondary Percent of patients requiring dialysis 1 year
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