The COVID-RASi Trial (COVID-19)
- Conditions
- COVID-19Cardiovascular Diseases
- Interventions
- Registration Number
- NCT04591210
- Lead Sponsor
- Ottawa Heart Institute Research Corporation
- 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.
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1155
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACEi treatment Angiotensin converting enzyme inhibitor The physician will initiate any ACE inhibitor and dose at their discretion. ARB treatment Angiotensin II Receptor Blockers The physician will initiate any ARB and dose at their discretion.
- Primary Outcome Measures
Name Time Method Hospitalizations 28 days Within first 28 days post randomization
Death 28 days Within first 28 days post randomization
ICU admission 28 days Within first 28 days post randomization
Quality of life of study participants 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
Mechanical ventilation 28 days Within first 28 days post randomization
Major Adverse Cardiac Events (MACE) 28 days Within first 28 days post randomization
- Secondary Outcome Measures
Name Time Method Cardiovascular mortality 1 year Days alive and out of hospital 180 days All cause hospitalization 1 year Percent of patients require intensive care 1 year Percent of patients requiring ventilation 1 year Percent of patients requiring dialysis 1 year
Trial Locations
- Locations (31)
Centro de Pesquisa Clinicas Dr Marco Mota
🇧🇷Maceio, Alagoas, Brazil
Santa Casa de Itabuna
🇧🇷Itabuna, Bahia, Brazil
Centro de Pesquisas em Diabetes e Doencas Endocrino-Metabolicas
🇧🇷Fortaleza, CE, Brazil
Hospital Felicio Rocho
🇧🇷Belo Horizonte, MG, Brazil
Centro de Pesquisa Clinica da Unimed Campo Grande
🇧🇷Campo Grande, MG, Brazil
Clinica de Campo Grande
🇧🇷Campo Grande, MG, Brazil
Nucleo de Pesquisa Clinica SS
🇧🇷Curitiba, Parana, Brazil
Hospital Agamenom Magalhaes
🇧🇷Recife, PE, Brazil
Pronto Socorro Cardiologico de Pernambuco Recife
🇧🇷Recife, PE, Brazil
Hospital Eduardo Campos da Pessoa Idosa
🇧🇷Estancia, Recife, Brazil
Scroll for more (21 remaining)Centro de Pesquisa Clinicas Dr Marco Mota🇧🇷Maceio, Alagoas, Brazil