COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49293

DR VIJAY KUMAR

vijaykr@aiimspatna.org

2020-11-19

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

All patients above the age of 14 years both males and females, admitted with a <br/ >diagnosis of mild or moderate COVID -19 (on the basis of a positive RT-PCR report) at our facility <br/ >during the study period (01/09/2020-31/12/2020)

1. Patients with a known allergy to or adverse drug reaction with Montelukast. <br/ >2. Patients unable to provide consent or unwilling to participate in the study. <br/ >3. Patients included in any other ongoing trial will be excluded from the study. <br/ >4. Patients below the age of 14 years will be excluded from the study. <br/ >5. Pregnant and Lactating Females will be excluded from the study.

2

Not reported

14

75

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

90

1. Progression of the disease to severe grade. <br/ >2. Admission to ICU . <br/ > <br/ >3. Need for mechanical ventilation. <br/ >4. In-hospital mortalityTimepoint: At every week

| Declared number of arm (2.0) differs from found arms (3.0)

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"}]