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The COVID-RASi Trial (COVID-19)

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ClinicalTrials.gov Identifier: NCT04591210
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
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 who are at high-risk for cardiovascular disease. 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 high-risk older 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.

Condition or disease Intervention/treatment Phase
COVID-19 Cardiovascular Diseases Drug: Angiotensin converting enzyme inhibitor Drug: Angiotensin II Receptor Blockers Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Experimental: ACEi treatment
The physician will initiate any ACE inhibitor and dose at their discretion.
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.

Experimental: ARB treatment
The physician will initiate any ARB and dose at their discretion.
Drug: 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.




Primary Outcome Measures :
  1. Death [ Time Frame: 28 days ]
    Within first 28 days post randomization

  2. Mechanical ventilation [ Time Frame: 28 days ]
    Within first 28 days post randomization

  3. ICU admission [ Time Frame: 28 days ]
    Within first 28 days post randomization

  4. Major Adverse Cardiac Events (MACE) [ Time Frame: 28 days ]
    Within first 28 days post randomization


Secondary Outcome Measures :
  1. Days alive and out of hospital [ Time Frame: 30 days ]
  2. Days alive and out of hospital [ Time Frame: 180 days ]
  3. Cardiovascular mortality [ Time Frame: 1 year ]
  4. All cause hospitalization [ Time Frame: 1 year ]
  5. Percent of patients require intensive care [ Time Frame: 1 year ]
  6. Percent of patients requiring ventilation [ Time Frame: 1 year ]
  7. Percent of patients requiring dialysis [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with COVID-19 diagnosis with laboratory confirmation within the last 30 days AND
  • Age 65 years old or greater if outpatient OR age over 40 years old 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, or orthostatic hypotension
  • Acute respiratory distress syndrome requiring invasive ventilation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591210


Contacts
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Contact: Ermina Moga 613-696-7000 ext 10945 EMoga@ottawaheart.ca

Locations
Show Show 19 study locations
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Peter Liu, MD Ottawa Heart Institute Research Corporation
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT04591210    
Other Study ID Numbers: CTO-3212
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Heart Institute Research Corporation:
cardiovascular risk factors
corona virus
COVID-19
severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
elderly
senior
Angiotensin-converting enzyme inhibitors
ACEi
Renin-angiotensin system inhibitors
RASi
Angiotensin receptor blockers
ARB
Additional relevant MeSH terms:
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COVID-19
Cardiovascular Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Angiotensin II
Giapreza
Enzyme Inhibitors
Angiotensinogen
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors