NCT04347174

A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients

A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cadila Pharnmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.

Detailed description

In this study, Eligible patients will be enrolled after due consent and will be randomized in balance to receive either test drug (along with the standard of care) or Placebo (along with the standard of care). The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite by the treating physician. In addition to the standard care for COVID-19, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw, intradermal, for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Placebo, intradermal, for 3 consecutive days. Study duration for each patient will be upto 28 days post-randomization.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Suspension of heat killed (autoclaved) Mycobacterium w	Patients will be randomized to receive either Mycobacterium w in combination with standard care as per hospital practice or standard care alone in COVID-19 as per hospital practice.
DRUG	Placebo	All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician

Timeline

• Start date: 2020-04-30
• Primary completion: 2020-08-10
• Completion: 2020-08-21
• First posted: 2020-04-15
• Last updated: 2021-01-27

Locations

4 sites across 1 country: India