An interventional study of Suspension of heat killed (autoclaved) Mycobacterium w and Placebo in COVID-19, sponsored by Cadila Pharnmaceuticals. Completed at 4 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Cadila Pharnmaceuticals · Not applicable, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Cadila Pharnmaceuticals is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of the following:
Exclusion Criteria:
0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19
Drug: Suspension of heat killed (autoclaved) Mycobacterium w
0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days
Drug: Placebo
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.
Also known as: Standard care of treatment for COVID-19 as per hospital practice
All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician
Also known as: Standard care of treatment for COVID-19 as per hospital practice
7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)
To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Time frame: Change in Ordinal scale from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.
Sequential Organ Failure Assessment (SOFA) scores
To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Time frame: Change in SOFA score from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.
Incidence of AE / SAE or event of clinical significance
Any AE / SAE or event of clinical significance observed during the study.
Time frame: Till day 28
SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample
Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
Time frame: At days 3, 7, 14, 21, and 28
ICU length of stay
ICU length of stay
Time frame: Till day 28
Duration of mechanical ventilation
Duration of mechanical ventilation
Time frame: Till day 28
Duration of hospitalization
Duration of hospitalization
Time frame: Till day 28
Clinical improvement
Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.
Time frame: From baseline to day 14 & Day 28
Time (in days) from treatment initiation to death
Time (in days) from treatment initiation to death.
Time frame: Till day 28
All-cause mortality
All-cause mortality
Time frame: Till day 28
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Cadila Pharnmaceuticals