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.
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.
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: RAAS inhibitor [continued standard of care]
No intervention, Continuation RAAS inhibitor [continued standard of care].
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.
Abhinav Sharma, MD
5149341934
abhinav.sharma@mcgill.ca
Julie Lebel, PM
5147912705
julie.lebel@muhc.mcgill.ca
Abhinav Sharma, MD, Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre