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

COVID-19 Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19
• Critical Illness
• Mycobacterium Infections

• NCT number: NCT04347174
• Study type: Interventional
• Source: Cadila Pharnmaceuticals
• Status: Completed
• Phase: N/A
• Start date: April 30, 2020
• Completion date: August 21, 2020