A clinical trial to evaluate the safety and efficacy of Mycobacterium W in critically ill patients suffering from COVID 19 infection

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J00-J99- Diseases of the respiratory system
Sponsor: Cadila Pharmaceuticals Limited
Enrollment: 16
Status: Completed
Last Updated: 3 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 3, 2020

Last Updated

3 years ago

Study Type

Interventional

Sponsor

•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 Ã¢â?°Â¥25 breaths/minute, and at least one of the following:
•\- SpO2 Ã¢â?°Â¤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.

•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 \< 30\)
•9\. Patients not likely to complete the trial as per judgment of the investigator.