COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04389411

Machelle Wilchesky, PhD

machelle.wilchesky@mcgill.ca

2020-05-15

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: 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.

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.

2

McGill University

18

None

None

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

250

C-Reactive Protein;Symptom Severity

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 816, "treatment_name": "Montelukast", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]