NCT04358809

Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill

A Randomized, Double-blind, Two Arm, Controlled Clinical Trial to Compare the Efficacy and Safety of Mycobacterium w (Mw) Administered Along With Standard of Care Versus Placebo Administered Along With Standard of Care, in Adult, COVID 19 Positive Patients Hospitalized But Not Critically Ill.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Cadila Pharnmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.

Detailed description

Total 480 hospitalized adult eligible patients will be randomized in 1:1 ratio to receive either Mw+SOC or placebo+SOC for first 3 days post-randomization. Daily clinical evaluation of patient will be performed till discharge from hospital or till ICU admission. Study duration for each patient will be approximately up to 28 days, or discharge from hospital or transfer to ICU, whichever is earlier.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Suspension of heat killed (autoclaved) Mycobacterium w	Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19
OTHER	Placebo	Placebo along with Standard of care (SOC) treatment for COVID-19

Timeline

• Start date: 2020-06-30
• Primary completion: 2021-02-28
• Completion: 2021-04-30
• First posted: 2020-04-24
• Last updated: 2020-12-22

Locations

4 sites across 1 country: India