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

Cadila Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: COVID-19

Treatments: Other: Placebo; Drug: Suspension of heat killed (autoclaved) Mycobacterium w

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04358809

CRSC20006

Details and patient eligibility

About

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 with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.

Full 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 be performed till discharge from hospital or till ICU admission.

Study duration for each patient will be approximately up to 28 days, or discharge from hospital or transfer to ICU, whichever is earlier.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 2 patient groups, including a placebo group

Suspension of Mw + Standard therapy of COVID-19

Experimental group

Description:

0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19

Treatment:

Drug: Suspension of heat killed (autoclaved) Mycobacterium w

Placebo

Placebo Comparator group

Description:

0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19

Treatment:

Other: Placebo