The McGill RAAS-COVID-19 Trial

McGill University

Status: Completed

Conditions: COVID-19; Cardiovascular Diseases

Treatments: Other: RAAS inhibitor [continued standard of care]; Other: Temporarily holding the RAAS inhibitor [intervention]

Study type: Interventional

Funder types: Other

Identifiers

NCT04508985

MP-37-2021-6614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

Other: Temporarily holding the RAAS inhibitor [intervention]

Continuation of standard of care

Other group

Description:

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

Treatment:

Other: RAAS inhibitor [continued standard of care]