Role of heat killed Mycobacterium w (Sepsivac) in Corona virus disease 2019 (COVID-19)
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/09/027741
- Lead Sponsor
- Cadila Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Laboratory confirmed symptomatic COVID-19 patients with ordinal scale of 3& 4.
2.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.
3.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.
1.Patient with ordinal scale of >=5 at the time of hospital admission and randomization.
2.Pregnant and / or lactating female patients.
3.A family history of congenital or hereditary immunodeficiency.
4.Any disease condition requiring ICU admission or which in the judgment of the Investigator would compromise the patientâ??s health.
5.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.
6.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.
7.History of allergic reactions or anaphylaxis to Mycobacterium w or its component.
8.Patients with generalized septic skin conditions.
9.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 patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method