Management of Renin-Angiotensin-Aldosterone System blockade in patients admitted to hospital with confirmed coronavirus disease (COVID-19) infection (The McGill RAAS-COVID- 19): A structured summary of a study protocol for a randomized controlled trial

• Type: Article in International Scientific Journal
• Date: 2021

Authors

Aflaki, M (Author) Other; Flannery, A (Author) Other; Ferreira, JP (Author) FMUP; Cheng, MP (Author) Other; Kronfli, N (Author) Other; Marelli, A (Author) Other; Zannad, F (Author) Other; Brophy, J (Author) Other; Afillalo, J (Author) Other; Huynh, T (Author) Other; Giannetti, N (Author) Other; Bessissow, A (Author) Other; Ezekowitz, JA (Author) Other; Lopes, RD (Author) Other; Ambrosy, AP (Author) Other; Craig, M (Author) Other; Sharma, A (Author) Other

Journal

Title: Trials

Vol. 26

ISSN: 1745-6215

Publisher: Springer Nature

Other information

Authenticus ID: P-00V-8R9

DOI: 10.1186/s13063-021-05080-4

Abstract (EN): <jats:title>Abstract</jats:title><jats:sec> <jats:title>Objectives</jats:title> <jats:p>The aim of the RAAS-COVID-19 randomized control trial is to evaluate whether an upfront strategy of temporary discontinuation of renin angiotensin aldosterone system (RAAS) inhibition versus continuation of RAAS inhibition among patients admitted with established COVID-19 infection has an impact on short term clinical and biomarker outcomes. We hypothesize that continuation of RAAS inhibition will be superior to temporary discontinuation with regards to the primary endpoint of a global rank sum score. The global rank sum score has been successfully used in previous cardiovascular clinical trials.</jats:p> </jats:sec><jats:sec> <jats:title>Trial design</jats:title> <jats:p>This is an open label parallel two arm (1,1 ratio) randomized control superiority trial of approximately 40 COVID-19 patients who are on chronic RAAS inhibitor therapy.</jats:p> </jats:sec><jats:sec> <jats:title>Participants</jats:title> <jats:p>Adults who are admitted to hospital within the McGill University Health Centre systems (MUHC) including Royal Victoria Hospital (RVH), Montreal General Hospital (MGH) and Jewish General Hospital (JGH) and who are within 96 hours of COVID-19 diagnosis (confirmed via PCR on any biological sample) will be considered for the trial. Of note, the initial protocol to screen and enrol within 48 hours of COVID-19 diagnosis was extended through an amendment, to 96 hours to increase feasibility. Participants have to be 18 years or older and would have to be on RAAS inhibitors for at least a month to be considered eligible for the study. Additionally, RAAS inhibitors should not have been held for more than 48 hours before randomization. A list of inclusion and exclusion criteria can be found in the full protocol document. In order to prevent heart failure exacerbation, patients with reduced ejection fraction were excluded from the trial.</jats:p> <jats:p>Once a patient is admitted on the ward with a diagnosis of COVID-19, we will confirm with the treating physician if the participant is suitable for the RAAS-COVID trial and meets all the inclusion and exclusion criteria. If the patient is eligible and informed consent has been obtained we will collect data on sex, age, ethnicity, past medical history and list of medications (e.g. other anti-hypertensives or anticoagulants), for further analysis.</jats:p> </jats:sec><jats:sec> <jats:title>Intervention and comparator</jats:title> <jats:p>All the study participants will be randomized to a strategy of temporarily holding the RAAS inhibitor [intervention] versus continuing the RAAS inhibitor [continued standard of care]. Among participants who are randomized to the intervention arm, alternative guide-line directed anti-hypertensive medication will be provided to the treating physician team (detail in study protocol). In the intervention arm RAAS inhibitor will be withheld for a total of 7 days with the possibility of the withdrawn medication being initiated at any point after day 7 or on the day of discharge. The recommendation for re-initiating the withdrawn medication will be made to the treating physician. The re-initiation of these therapies are according to standard convention and follow-up as per Canadian guidelines. Additionally, the date of restarting the withdrawn medication or whether the medication was re-prescri

Language: English

Type (Professor's evaluation): Dissemination