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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19
Placebo along with Standard of care (SOC) treatment for COVID-19
All India Institute of Medical Science, Raipur
Raipur, Chhattisgarh, India
RECRUITINGAll India Institute of Medical Sciences, Bhopal
Bhopal, India
RECRUITINGPost Graduate Institute of Medical Education and Research
Chandigarh, India
RECRUITINGNumber of patients with increased disease severity
To compare the difference in proportion of patients with increased disease severity
Time frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
Incidence of adverse events and serious adverse events (Safety)
To evaluate safety of Mw in COVID-19 patients admitted to hospital
Time frame: Till day 28
Number of COVID-19 patients discharged from hospital
To compare the proportion of patients discharged from hospital
Time frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
Number of COVID-19 patients transfer to ICU
To compare the proportion of patients transfer to ICU
Time frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale
To compare the proportion of patients with reduction in disease severity by 1 ordinal scale
Time frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
Number of of symptom free patients
To compare the proportion of symptom free patients
Time frame: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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All India Institute of Medical Sciences, Delhi
Delhi, India
RECRUITING