Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill

Phase 3

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/05/025271
• Lead Sponsor: Cadila Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-07-13
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 481

Inclusion Criteria

1. COVID-19 positive patients with ordinal scale score of 3 with comorbid illness including diabetes mellitus, hypertension, chronic lung disease, immunocompromised status, active malignancy, chronic kidney disease, chronic liver disease, obesity (BMI >25Kg/m2), or subjects who have doubling of CRP compared to baseline or have Neutrophil-to-Lymphocyte Ratio �3.5.

2. Patients of either gender, age � 18 years at the time of enrollment.

3. 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.

4. 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

1. Patient with ordinal scale of �4 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.

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 Mw or its component.

8. 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 patientââ?¬•s health or is likely to result in nonconformance to the protocol or a patientââ?¬•s ability to give written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients with increased disease severityTimepoint: From baseline to at any time during the study till 28 days post first dosing.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events and serious adverse events (Safety)Timepoint: Till day 28;Number of COVID-19 patients discharged from hospitalTimepoint: From baseline to at any time during the study till 28 days post first dosing.;Number of COVID-19 patients transfer to ICUTimepoint: From baseline to at any time during the study till 28 days post first dosing.;Number of COVID-19 patients with reduction in disease severity by 1 ordinal scaleTimepoint: From baseline to at any time during the study till 28 days post first dosing.;Number of of symptom free patientsTimepoint: From baseline to at any time during the study till 28 days post first dosing.