COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43004

Dr Anil Avhad

anil.avhad@cadilapharma.co.in

2020-04-24

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Critically ill COVID-19 patients who have been tested positive by RT-PCR for SARS-CoV-2 on the nasopharyngeal or throat swabs. <br/ >2. Patient aged 18 years or more of either gender <br/ >3. Illness of any duration with respiratory rate â?¥25 breaths/minute, and at least one of the following: <br/ >- SpO2 â?¤90% on room air, or <br/ >- Requiring mechanical ventilation and/or supplemental oxygen <br/ >4. Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. <br/ >5. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.

1. Pregnant or nursing female. <br/ >2. Patients with history of allergy, hypersensitivity, or any serious reaction to study medication <br/ >3. Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk. <br/ >4. Patient previously enrolled into this study. <br/ >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. <br/ >6. Patients with a life expectancy judged to be less than five days <br/ >7. ALT/AST > 5 times the upper limit of normal <br/ >8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) <br/ >9. Patients not likely to complete the trial as per judgment of the investigator.

2

Cadila Pharmaceuticals Limited

18

99

India

Critical disease at enrollment

8: Critical disease at enrollment

300

1. To evaluate the efficacy of Mw by measuring the improvement in Ordinal scale. <br/ > <br/ >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. <br/ > <br/ >2.Till day 28; post-randomization or death or discharge; whichever is earlier.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "Not reported", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Not reported", "treatment_id": 143, "treatment_name": "Autoclaved mycobacterium", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]