Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04508985
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2020-08-10
Brief Title:
The McGill RAAS-COVID-19 Trial
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAAS-COVID
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 11 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 teams 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None