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

Primary Purpose

COVID-19, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Temporarily holding the RAAS inhibitor [intervention]
RAAS inhibitor [continued standard of care]
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Renin, Angiotensin, Aldosterone, coronavirus, Cardiovascular Diseases, COVID-19

Eligibility Criteria

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

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.

Sites / Locations

  • Muhc-Rimuhc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Continuation of standard of care

Arm Description

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.

No intervention, Continuation RAAS inhibitor [continued standard of care].

Outcomes

Primary Outcome Measures

Global rank score
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.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2020
Last Updated
August 3, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT04508985
Brief Title
The McGill RAAS-COVID-19 Trial
Acronym
RAAS-COVID
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Cardiovascular Diseases
Keywords
Renin, Angiotensin, Aldosterone, coronavirus, Cardiovascular Diseases, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Open-label, 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 on discharge) versus a strategy continuation of RAAS inhibition.
Masking
None (Open Label)
Masking Description
The patient and the treating doctor will be informed of the assigned treatment.
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuation of standard of care
Arm Type
Other
Arm Description
No intervention, Continuation RAAS inhibitor [continued standard of care].
Intervention Type
Other
Intervention Name(s)
Temporarily holding the RAAS inhibitor [intervention]
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
RAAS inhibitor [continued standard of care]
Intervention Description
No intervention, Continuation RAAS inhibitor [continued standard of care].
Primary Outcome Measure Information:
Title
Global rank score
Description
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.
Time Frame
Baseline - day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhinav Sharma, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhc-Rimuhc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be de-identified and shared among all collaborators.
IPD Sharing Time Frame
Immediate access to the data
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Links:
URL
https://www.biorxiv.org/content/10.1101/2020.01.31.929042v1
Description
The novel coronavirus 2019 (2019-nCoV) uses the SARS-coronavirus receptor ACE2 and the cellular protease TMPRSS2 for entry into target cells
URL
https://digitalcommons.wayne.edu/cgi/viewcontent.cgi?article=2451&context=jmasm
Description
Power and sample size estimation for nonparametric composite endpoints: Practical implementation using data simulations.

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The McGill RAAS-COVID-19 Trial

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