The Covid-19 Outpatient Symptom Montelukast Oximetry Trial
COSMO
Repurposing Montelukast for the Attenuation and Prophylaxis of Severe COVID-19 Symptoms: The COvid-19 Symptom MOntelukast (COSMO) Trial
1 other identifier
interventional
250
0 countries
N/A
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 currently approved for use in the outpatient setting by Health Canada have excluded pregnant women and older adults from their clinical trials, are contraindicated for many patients, and most are prohibited for use by pregnant women. Identification of a safe, COVID-19 outpatient therapeutic with 20-year safety record remains urgently needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Nov 2022
Longer than P75 for phase_2 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedJuly 25, 2022
July 1, 2022
2 months
May 13, 2020
July 19, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Symptom Severity
Symptom severity during the first 14 days of follow-up as measured by differences in mean FluPro PLUS scores
14 days
C-Reactive Protein
C-Reactive Protein a biomarker of inflammation associated with severe COVID, obtained on days 3, 6, 9, and 14 of follow-up
14 days
Secondary Outcomes (10)
Duration of symptoms
90 days
Interleukin IL-6
14 days
Hypoxemia incidence
30 days
Hypoxemia
30 days
Functional Status
30 days
- +5 more secondary outcomes
Study Arms (2)
Montelukast
EXPERIMENTAL10mg Oral Montelukast once daily for 60 days
Placebo
PLACEBO COMPARATORPlacebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill Universitylead
- Segal Cancer Centrecollaborator
- The McGill Practice Based Research Networkcollaborator
- Lady Davis Institutecollaborator
Related Publications (1)
Sanghai N, Tranmer GK. Taming the cytokine storm: repurposing montelukast for the attenuation and prophylaxis of severe COVID-19 symptoms. Drug Discov Today. 2020 Dec;25(12):2076-2079. doi: 10.1016/j.drudis.2020.09.013. Epub 2020 Sep 16.
PMID: 32949526BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Machelle Wilchesky, PhD
Lady Davis Institute and McGill University
- PRINCIPAL INVESTIGATOR
Geoffrey Tranmer, PhD
University of Manitoba
- PRINCIPAL INVESTIGATOR
Roland Grad, MDCM MSc FCFP
Herzl Family Practice Centre and McGill University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Montelukast and placebo tablets will be over encapsulated before distribution to trial participants.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 15, 2020
Study Start
November 1, 2022
Primary Completion
January 1, 2023
Study Completion
February 1, 2025
Last Updated
July 25, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- We will make this data available within 12 months of completion of data collection.
- Access Criteria
- Undetermined.
COSMO Trial Data Governance Plan: We have designed the COSMO Trial to uphold the FAIR principles such that the research data derived will be Findable, Accessible, Interoperable, and Reusable. The raw data from this study, once removed of identifiers, will be posted to a public data sharing resource to allow the data to be used and understood by the wider scientific community. The precise platforms and open access data repositories will be determined once the data is ready, but candidate platforms include github and the Google COVID-19 data sharing platform.