The COvid-19 Symptom MOntelukast Trial

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Due to the rapidly developing nature and severity of the COVID-19 pandemic, clinical trials involving a repurposed drug approach are the best option for rapidly identifying an effective COVID-19 therapeutic. The investigators propose to evaluate the efficacy of Montelukast in attenuating cytokine storm syndrome and ARDS via a randomized, blinded, placebo-controlled clinical trial. Specifically, our primary objective is comparing the efficacy of low-dose Montelukast versus placebo in reducing the risk of acute care visits and hospital admissions among COVID-19 positive patients in the general population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University
• Collaborator: Lady Davis Institute
• Treatments: Montelukast

Criteria

Inclusion Criteria:

1. Confirmed SARS-CoV-2 infection, defined as RT-PCR provincial laboratory confirmation;

2. Time from a positive test result to date of enrollment <1 week;

3. Time from patient reported first symptoms date of enrollment <14 days;

4. Able to complete weekly follow-up assessments and agrees to provide them on a weekly basis;

5. Agrees to use assigned medication for the 60 days prescribed; and

6. Informed consent is obtained.

Exclusion Criteria:

1. Any hospitalization for COVID-19 symptoms or complications prior to randomization;

2. Use of montelukast ≤ 30 days to screening;

3. Any contraindication to montelukast; and

4. Any condition (including the inability to swallow pills) which, in the opinion of the Principal Investigator, would prevent full participation in and compliance with the trial protocol, or would interfere with the evaluation of trial endpoints.