Status:
UNKNOWN
The Covid-19 Outpatient Symptom Montelukast Oximetry Trial
Lead Sponsor:
McGill University
Collaborating Sponsors:
Segal Cancer Centre
The McGill Practice Based Research Network
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Primary care physicians face limited availability of therapeutic options for the treatment of COVID-19 in the outpatient setting. Furthermore, monoclonal antibodies and antiviral therapies that are cu...
Detailed Description
Objectives: Our overarching objective is to determine the efficacy of oral montelukast versus placebo in reducing the duration and severity of COVID-19 symptoms among newly infected at-risk adults in ...
Eligibility Criteria
Inclusion
- Confirmed SARS-CoV-2 infection, defined as RT-PCR provincial laboratory confirmation;
- Time from patient reported first symptoms date of enrollment \<7 days;
- Must be experiencing at least 1 COVID-19 symptom that is either continuing or increasing in severity
- Severe disease risk factor requirements: i) Age 18-49: ≥3 risk factors ; ii) Age 50-59: ≥2 risk factors; iii) Age 60-69: ≥1 risk factor; iv) Pregnant or Age 70+: No requirements
- Participants must agree to: i) Use assigned medication for a maximum of 60 days or until relief of symptoms; and ii) Complete the FLU-PRO PLUS and SpO2 daily diary and other study assessments during the course of follow-up.
Exclusion
- Any hospitalization for COVID-19 symptoms or complications prior to randomization;
- Use of montelukast ≤ 30 days to screening;
- Any contraindication to montelukast; and
- 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.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04389411
Start Date
November 1 2022
End Date
February 1 2025
Last Update
July 25 2022
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