Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Suspension of heat killed (autoclaved)Mycobacterium w: 0.3 ml (0.1 ml x 3 Inj.) of Mw intra-dermal for 3 consecutive days with Standard therapy of COVID-19
Control Intervention1: Placeb
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Critically ill COVID-19 patients who have been tested positive by RT-PCR for SARS-CoV-2 on the nasopharyngeal or throat swabs. 2. Patient aged 18 years or more of either gender 3. Illness of any duration with respiratory rate �25 breaths/minute, and at least one of the following: - SpO2 �90% on room air, or - Requiring mechanical ventilation and/or supplemental oxygen 4. Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. 5. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing female. 2. Patients with history of allergy, hypersensitivity, or any serious reaction to study medication 3. Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk. 4. Patient previously enrolled into this study. 5. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukemia or HIV. 6. Patients with a life expectancy judged to be less than five days 7. ALT/AST > 5 times the upper limit of normal 8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR 9. Patients not likely to complete the trial as per judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of Mw by measuring the improvement in Ordinal scale. 2. To evaluate 28-day mortality.Timepoint: 1. From baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days. 2.Till day 28, post-randomization or death or discharge, whichever is earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Change in Sequential Organ Failure Assessment (SOFA) scoreTimepoint: Baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days post-randomization.;To evaluate the safety/tolerability by determining the incidence of adverse events in the MwTimepoint: Any AE / SAE or event of clinical significance observed during the study. | — |
Countries
India
Contacts
Public ContactDr Anil Avhad
Cadila Pharmaceuticals Limited
Outcome results
None listed