NCT04353518

Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19

A Randomized, Double-blind, Two Arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: Cadila Pharnmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.

Detailed description

Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria. Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered. Study duration for each subject will be of 8 weeks.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Suspension of heat killed (autoclaved) Mycobacterium w	Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.
OTHER	Placebo	Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.

Timeline

• Start date: 2020-06-30
• Primary completion: 2021-03-30
• Completion: 2021-05-30
• First posted: 2020-04-20
• Last updated: 2020-12-22

Locations

3 sites across 1 country: India