Status:
UNKNOWN
Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill
Lead Sponsor:
Cadila Pharnmaceuticals
Collaborating Sponsors:
Council of Scientific and Industrial Research, India
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo...
Detailed Description
Total 480 hospitalized adult eligible patients will be randomized in 1:1 ratio to receive either Mw+SOC or placebo+SOC for first 3 days post-randomization. Daily clinical evaluation of patient will b...
Eligibility Criteria
Inclusion
- COVID-19 positive patients with ordinal scale score of 3.
- Patients of either gender, age ≥ 18 years at the time of enrollment.
- Female patients who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing.
- The patients must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.
Exclusion
- Patient with ordinal scale of ≥4 at the time of hospital admission and randomization.
- Pregnant and / or lactating female patients.
- A family history of congenital or hereditary immunodeficiency.
- Any disease condition requiring ICU admission.
- History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator.
- History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period.
- History of allergic reactions or anaphylaxis to Mw or its component.
- Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patient's health or is likely to result nonconformance to the protocol or a patient's ability to give written informed consent.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04358809
Start Date
June 30 2020
End Date
April 30 2021
Last Update
December 22 2020
Active Locations (4)
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1
All India Institute of Medical Science, Raipur
Raipur, Chhattisgarh, India, 492099
2
All India Institute of Medical Sciences, Bhopal
Bhopal, India
3
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012.
4
All India Institute of Medical Sciences, Delhi
Delhi, India, 110029