The study is a three arm, double blind, placebo controlled, clinical trial to assess the dose related effect of heat killed Mycobacterium w versus Placebo administered along with Standard care in Patients of COVID-19.

Time bound study for one year  of duration.

Written and informed consent shall be taken from the patient prior to study. This is a randomized, double blind, three arm, time bound study for 1 year wherein laboratory confirmed symptomatic COVID-19 patients admitted in COVID-19 isolation ward at SGT Hospital shall be included after the inclusion and exclusion criteria have been applied. The patients will be randomly divided into 3 groups. Selection of patients in either group will be random as per randomization list and accordingly patient will be enrolled in either of the study group to receive study medication (either Mw or placebo) as per randomization list. Patients in control group would be administered placebo in a dose of 0.3 ml intradermally daily for 3 consecutive days at 3 different sites. The test group would be further divided into 2 groups. Patients in Group A shall be administered 0.3ml daily of Sepsivac intradermally in divided doses of 0.1 ml each for 3 consecutive days at 3 different sites. Patients in Group B would be administered 0.3 ml of Sepsivac intradermally in divided doses of 0.1 ml at three different sites for 1 day and placebo 0.3 ml intra dermally daily for next two consecutive days. A smaller gauge needle (26 G) would be used.

Study duration for each patient would be till the time of discharge from hospital or till day 28 from the first dose administration. Study medication will be administered for three consecutive days along with standard of care. The standard of care therapy for COVID-19 would be given to every patient as per hospital practice. 

During hospitalization, daily clinical evaluation and assessment of patient will be done as per study calendar and recorded in the proforma till the time of discharge from hospital. 

Study Group	Treatment Allocation
Treatment Group 1	Heat killed Mycobacterium w suspension group: 0.3 ml of Mw daily (0.1 ml x3injections) intradermally at 3 different sites for 3 consecutive days along with standard therapy of COVID-19.
Treatment Group 2	Heat killed Mycobacterium w suspension + placebo group: 0.3 ml of Mw (0.1 ml x 3 injections) intradermally at 3 different sites for 1 day followed by 0.3 ml (0.1 ml x 3 injections) of placebointradermally at 3 different sites for next 2 consecutive days along with standard therapy of COVID-19.
Treatment Group 3	Placebo group: 0.3 ml daily (0.1 ml x 3 injections) of placebo intradermally at 3 different sites for 3 consecutive days along with standard therapy of COVID-19.

STUDY CALENDER

^$Screening activities can be conducted either at baseline or during day 1 visit prior to dosing (same day screening).

#Activities to be performed daily during hospitalization till recovery.

@End of study (Upto Day 28 or till recovery [discharge from hospital]

*Will be performed during base line / screening and on Day 4, subsequently it will be performed as per hospital’s standard procedure.

If any other investigation performed, will be documented.

If patient is discharged from hospital earlier than 28 days, the activities of End of Study will be performed as per calendar on the day of discharge and in case patient is transfer to HDU/ICU during the course of study earlier than 28 days, the efficacy analysis and activities of End of study  and safety follow up will continue till day 28 post-1st dose.