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The COVID-RASi Trial (COVID-19)

Primary Purpose

COVID-19, Cardiovascular Diseases

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Angiotensin converting enzyme inhibitor
Angiotensin II Receptor Blockers
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring cardiovascular risk factors, corona virus, COVID-19, severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), Angiotensin-converting enzyme inhibitors, ACEi, Renin-angiotensin system inhibitors, RASi, Angiotensin receptor blockers, ARB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Pesquisa Clinicas Dr Marco Mota
  • Santa Casa de Itabuna
  • Centro de Pesquisas em Diabetes e Doencas Endocrino-Metabolicas
  • Hospital Felicio Rocho
  • Centro de Pesquisa Clinica da Unimed Campo Grande
  • Clinica de Campo Grande
  • Nucleo de Pesquisa Clinica SS
  • Hospital Agamenom Magalhaes
  • Pronto Socorro Cardiologico de Pernambuco Recife
  • Hospital Eduardo Campos da Pessoa Idosa
  • Instituto Atena de Pesquisa Clinica
  • Hospital Universitar Canoas
  • Hospital Sao Vicente de Paulo
  • Hospital Sao Lucas da PUCRS
  • Hospital Universitario Sao Francisco na Providencia de Deus
  • Instituto de Pesquisa Clinica de Campinas
  • Hospital Bela Vista
  • Instituto Prevent Senior
  • Hospital de Julho
  • Instituto de Coracao
  • Instituto Goiano de Oncologia e Hematologia
  • Alberta Health Services
  • University of Ottawa Heart Institute
  • Hospital de Infectologia Dr Daniel Mendez Fernandez
  • Unidad de Medicina Familiar No 77
  • Hospital General de Zona 20
  • Hospital General Regional No 2
  • Hospital General zona 11
  • Unidad de Medicina Familiar No 10
  • Hospital General 1, IMSS
  • Hospital General de zona 27- IMSS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No Treatment (Standard of Care)

ACEi treatment

ARB treatment

Arm Description

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.

The physician will initiate any ACE inhibitor and dose at their discretion.

The physician will initiate any ARB and dose at their discretion.

Outcomes

Primary Outcome Measures

Death
Within first 28 days post randomization
Mechanical ventilation
Within first 28 days post randomization
ICU admission
Within first 28 days post randomization
Major Adverse Cardiac Events (MACE)
Within first 28 days post randomization
Hospitalizations
Within first 28 days post randomization
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
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

Secondary Outcome Measures

Days alive and out of hospital
Days alive and out of hospital
Cardiovascular mortality
All cause hospitalization
Percent of patients require intensive care
Percent of patients requiring ventilation
Percent of patients requiring dialysis

Full Information

First Posted
October 6, 2020
Last Updated
May 26, 2023
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04591210
Brief Title
The COVID-RASi Trial (COVID-19)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Cardiovascular Diseases
Keywords
cardiovascular risk factors, corona virus, COVID-19, severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), Angiotensin-converting enzyme inhibitors, ACEi, Renin-angiotensin system inhibitors, RASi, Angiotensin receptor blockers, ARB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Treatment (Standard of Care)
Arm Type
No Intervention
Arm Description
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.
Arm Title
ACEi treatment
Arm Type
Experimental
Arm Description
The physician will initiate any ACE inhibitor and dose at their discretion.
Arm Title
ARB treatment
Arm Type
Experimental
Arm Description
The physician will initiate any ARB and dose at their discretion.
Intervention Type
Drug
Intervention Name(s)
Angiotensin converting enzyme inhibitor
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Angiotensin II Receptor Blockers
Intervention Description
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 Outcome Measure Information:
Title
Death
Description
Within first 28 days post randomization
Time Frame
28 days
Title
Mechanical ventilation
Description
Within first 28 days post randomization
Time Frame
28 days
Title
ICU admission
Description
Within first 28 days post randomization
Time Frame
28 days
Title
Major Adverse Cardiac Events (MACE)
Description
Within first 28 days post randomization
Time Frame
28 days
Title
Hospitalizations
Description
Within first 28 days post randomization
Time Frame
28 days
Title
Quality of life of study participants
Description
Assessed by ongoing symptoms and standardized questionnaires, scale to assess overall health 1-100, 100 is the best, higher score means better outcome
Time Frame
1 year
Title
Quality of life of study participants
Description
Assessed by ongoing symptoms and standardized questionnaires- scale to assess overall health 1-100, 100 is the best, higher score means better outcome
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Days alive and out of hospital
Time Frame
30 days
Title
Days alive and out of hospital
Time Frame
180 days
Title
Cardiovascular mortality
Time Frame
1 year
Title
All cause hospitalization
Time Frame
1 year
Title
Percent of patients require intensive care
Time Frame
1 year
Title
Percent of patients requiring ventilation
Time Frame
1 year
Title
Percent of patients requiring dialysis
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Liu, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisa Clinicas Dr Marco Mota
City
Maceio
State/Province
Alagoas
Country
Brazil
Facility Name
Santa Casa de Itabuna
City
Itabuna
State/Province
Bahia
Country
Brazil
Facility Name
Centro de Pesquisas em Diabetes e Doencas Endocrino-Metabolicas
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60-430-350
Country
Brazil
Facility Name
Hospital Felicio Rocho
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Centro de Pesquisa Clinica da Unimed Campo Grande
City
Campo Grande
State/Province
MG
Country
Brazil
Facility Name
Clinica de Campo Grande
City
Campo Grande
State/Province
MG
Country
Brazil
Facility Name
Nucleo de Pesquisa Clinica SS
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80730-150
Country
Brazil
Facility Name
Hospital Agamenom Magalhaes
City
Recife
State/Province
PE
Country
Brazil
Facility Name
Pronto Socorro Cardiologico de Pernambuco Recife
City
Recife
State/Province
PE
Country
Brazil
Facility Name
Hospital Eduardo Campos da Pessoa Idosa
City
Estancia
State/Province
Recife
ZIP/Postal Code
50870-901
Country
Brazil
Facility Name
Instituto Atena de Pesquisa Clinica
City
Natal
State/Province
RN
Country
Brazil
Facility Name
Hospital Universitar Canoas
City
Canoas
State/Province
RS
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
State/Province
RS
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Universitario Sao Francisco na Providencia de Deus
City
Bragança Paulista
State/Province
Sao Paulo
ZIP/Postal Code
12916-542
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica de Campinas
City
Campinas
State/Province
SP
Country
Brazil
Facility Name
Hospital Bela Vista
City
Consolacao
State/Province
SP
Country
Brazil
Facility Name
Instituto Prevent Senior
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Hospital de Julho
City
São Paulo
State/Province
SP
ZIP/Postal Code
01409-901
Country
Brazil
Facility Name
Instituto de Coracao
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Instituto Goiano de Oncologia e Hematologia
City
Goiânia
Country
Brazil
Facility Name
Alberta Health Services
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Hospital de Infectologia Dr Daniel Mendez Fernandez
City
Azcapotzalco
State/Province
Ciudad De Mexico
ZIP/Postal Code
06900
Country
Mexico
Facility Name
Unidad de Medicina Familiar No 77
City
Ecatepec de Morelos
State/Province
Estado De Mexico
Country
Mexico
Facility Name
Hospital General de Zona 20
City
La Margarita
State/Province
Puebla
ZIP/Postal Code
72560
Country
Mexico
Facility Name
Hospital General Regional No 2
City
El Marques
State/Province
Queretaro
ZIP/Postal Code
76269
Country
Mexico
Facility Name
Hospital General zona 11
City
Xalapa
State/Province
Veracruz
ZIP/Postal Code
91000
Country
Mexico
Facility Name
Unidad de Medicina Familiar No 10
City
Xalapa
State/Province
Veracruz
ZIP/Postal Code
91000
Country
Mexico
Facility Name
Hospital General 1, IMSS
City
Ciudad de Mexico
Country
Mexico
Facility Name
Hospital General de zona 27- IMSS
City
Ciudad de Mexico
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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The COVID-RASi Trial (COVID-19)

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