The McGill RAAS-COVID-19 Trial (RAAS-COVID)

August 3, 2023 updated by: Abhinav Sharma, McGill University Health Centre/Research Institute of the McGill University Health Centre

Management of Renin-Angiotensin-Aldosterone System Blockade in Patients Admitted in Hospital With Confirmed Coronavirus Disease (COVID-19) Infection: The McGill RAAS-COVID-19 Randomized Controlled Trial

Coronavirus disease (COVID-19) related pneumonia significantly impact patients with underlying cardiovascular (CV) conditions. Animal studies suggest that drugs commonly used to treated CV diseases may increase the ability of COVID-19 to infect cells. The RAAS-COVID-19 trial aims to assess whether temporarily holding these CV drugs in patients who are admitted with COVID-19, versus continuing them, in patients admitted with COVID-19 can impact short term outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open-label, pragmatic, randomized, study of approximately 40 adults. The following groups of participants will be considered: i) within 48 hours of diagnosis of COVID-19; ii) who have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site (Royal Victoria Hospital, Montreal General Hospital, and Jewish General Hospital [all in Montreal, Quebec, Canada]). Participants will be randomized 1:1 to an upfront temporary discontinuation) of RAAS inhibition for the duration of the hospitalization (and to consider re-initiate after day 7 of admission or on discharge) versus a strategy continuation of RAAS inhibition. Re-initiation of held RAAS inhibition will be based on treating team's clinical judgement. The RAAS-COVID-19 RCT will evaluate whether an upfront strategy of temporary discontinuation of RAAS inhibition compared to the continuation of RAAS inhibition among patients admitted with established COVID-19 infection and on chronic RAAS inhibition therapy impacts short term clinical outcomes and biomarkers.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Muhc-Rimuhc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Hospitalization with a Covid-19 infection
  • Chronically treated with RAAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month
  • Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample
  • Participants are within 48 hours of diagnosis of COVID-19 or have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site

Exclusion Criteria:

  • Shock requiring vasoactive agents.
  • Requiring invasive mechanical ventilation.
  • History of malignant hypertension
  • Use of five or more antihypertensive drugs.
  • History of heart failure with reduced ejection fraction
  • History of hospitalization for acute heart failure in past 3 months
  • History of hospitalization for hemorrhagic stroke in the past 3 months.
  • History of CKD with an eGFR <45 ml/min/1.73m2
  • History of COPD GOLD III/IV
  • History of end-stage dementia
  • History of active liver cirrhosis
  • RAAS blockers therapy previously stopped > 48h.
  • Anticipated discharge in less than 24 hours.
  • History of current active cancer receiving chemotherapy
  • Inability to obtain informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Temporarily holding the RAAS inhibitor. Among participants who will be randomized to the intervention arm, a possible guideline-directed alternative to anti-hypertensive medication alternatives will be provided to the treating physician team.
Other: Temporarily holding the RAAS inhibitor [intervention]
Temporarily holding the RAAS inhibitor. Among participants who will be randomized to the intervention arm, a possible guideline-directed alternative to anti-hypertensive medication alternatives will be provided to the treating physician team.
Other: Continuation of standard of care
No intervention, Continuation RAAS inhibitor [continued standard of care].
Other: RAAS inhibitor [continued standard of care]
No intervention, Continuation RAAS inhibitor [continued standard of care].

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global rank score
Time Frame: Baseline - day 7

The primary end point is a global rank score which is applied to all participants. The global rank sum is based on the following endpoints (and corresponding score): Death (7); Transfer to ICU for Invasive ventilation (6); Transfer to ICU for other indication (5); Non-fatal MACE (Any of the following - MI, Stroke, Acute HF, new onset Afib) (4); Length of stay > 4 days (3); Development of acute kidney injury (>40% decline in eGFR or doubling of serum Cr) (2); Urgent intravenous treatment for high blood pressure/hypertensive crisis (2); >30% Increase in baseline high sensitivity troponin (1); >30% increase in baseline BNP (1); Increase in baseline CRP to 48 hours >30%(1); Lymphocyte count drop >30% (1).

The primary endpoint will be assessed from baseline to day 7 (or day of discharge if occurs before day 7). Participants will receive a weighted score depending on the events experienced. The global rank sum score will then be averaged and compared between treatment arms.
Baseline - day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Jewish General Hospital (Montreal, Quebec, Canada)
Montreal General Hospital (Montreal, Quebec, Canada)
Université de Lorraine, Centre d'Investigation Clinique- Plurithématique Inserm

Investigators

  • Principal Investigator: Abhinav Sharma, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 17, 2021

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-37-2021-6614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be de-identified and shared among all collaborators.

IPD Sharing Time Frame

Immediate access to the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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