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

NCT ID: NCT04358809

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-04-30

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 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.

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 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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Suspension of Mw + Standard therapy of COVID-19

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

Group Type: EXPERIMENTAL

Suspension of heat killed (autoclaved) Mycobacterium w

Intervention Type: DRUG

Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo along with Standard of care (SOC) treatment for COVID-19

Interventions

Suspension of heat killed (autoclaved) Mycobacterium w

Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19

Intervention Type: DRUG

Placebo

Placebo along with Standard of care (SOC) treatment for COVID-19

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Council of Scientific and Industrial Research, India

OTHER_GOV

Sponsor Role: collaborator

Cadila Pharnmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay Patel, MBBS

Role: STUDY_CHAIR

Cadila Pharmaceuticals Limited

Locations

All India Institute of Medical Science, Raipur

Raipur, Chhattisgarh, India

Site Status: RECRUITING

All India Institute of Medical Sciences, Bhopal

Bhopal, , India

Site Status: RECRUITING

Post Graduate Institute of Medical Education and Research

Chandigarh, , India

Site Status: RECRUITING

All India Institute of Medical Sciences, Delhi

Delhi, , India

Site Status: RECRUITING

Countries

India

Central Contacts

Anil Avhad, MBBS

Role: CONTACT

Phone: 919833454044

Email: anil.avhad@cadilapharma.co.in

Ashish Amarsheda

Role: CONTACT

Phone: 919898073861

Email: ashish.a@cadilapharma.co.in

Facility Contacts

Sajal De, MD

Role: primary

Sarman Singh, MD

Role: primary

Inderpaul Singh Sehgal, DM(Pulmonary Medicine)

Role: primary

Anant Mohan, MD

Role: primary

Other Identifiers

CRSC20006

Identifier Type: -

Identifier Source: org_study_id