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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

Tracking Information
First Submitted Date  ICMJE October 6, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date June 14, 2021
Actual Study Start Date  ICMJE January 27, 2021
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • Death [ Time Frame: 28 days ]
    Within first 28 days post randomization
  • Mechanical ventilation [ Time Frame: 28 days ]
    Within first 28 days post randomization
  • ICU admission [ Time Frame: 28 days ]
    Within first 28 days post randomization
  • Major Adverse Cardiac Events (MACE) [ Time Frame: 28 days ]
    Within first 28 days post randomization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • Days alive and out of hospital [ Time Frame: 30 days ]
  • Days alive and out of hospital [ Time Frame: 180 days ]
  • Cardiovascular mortality [ Time Frame: 1 year ]
  • All cause hospitalization [ Time Frame: 1 year ]
  • Percent of patients require intensive care [ Time Frame: 1 year ]
  • Percent of patients requiring ventilation [ Time Frame: 1 year ]
  • Percent of patients requiring dialysis [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The COVID-RASi Trial (COVID-19)
Official Title  ICMJE Evaluation of the Potential Benefit of Renin-angiotensin System Inhibitors (RASi, ACEi/ARB) in High-risk Patients With COVID-19. The COVID-RASi Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Cardiovascular Diseases
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Angiotensin converting enzyme inhibitor
  • Experimental: ARB treatment
    The physician will initiate any ARB and dose at their discretion.
    Intervention: Drug: Angiotensin II Receptor Blockers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2020)
1155
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ermina Moga 613-696-7000 ext 10945 EMoga@ottawaheart.ca
Listed Location Countries  ICMJE Brazil,   Canada,   Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04591210
Other Study ID Numbers  ICMJE CTO-3212
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Liu, MD Ottawa Heart Institute Research Corporation
PRS Account Ottawa Heart Institute Research Corporation
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP