Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Heat- killed Mycobacterium w:
Group 1-Heat killed Mycobacterium w suspension group:
0.3 ml of Mw daily (0.1 ml x3injections) intradermally at 3 different sites for 3 consecutive days
Sponsors
Cadila Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To compare the symptoms relief over the time among the three treatment group. 2.To compare the difference in proportion of patients with improved clinical outcome defined by ordinal scale over the time between the treatment groups. 3.To compare the duration for conversion of Covid-19 positive status to negative between the treatment groups. Timepoint: 1. Daily assessment of the patient. 2. At the end of 28 days or discharge of the patient- whichever is earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the incidence of adverse events and serious adverse events between the three arms till the end of study. 2.To compare the proportion of patients discharged from hospital or transfer to HDU/ICU over the time between the three arms. 3.To compare the proportion of patients with improvement in oxygenation. 4.To compare the proportion of symptom free patients over the time between the three arms. Timepoint: 1.Daily assessment of the patient. 2. At the end of 28 days or discharge of the patient - whichever is earlier. | — |
Countries
India
Contacts
Public ContactDr Dharampal Singh Sudan
SGT Hospital Medical College & Research Institute
Outcome results
None listed