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

NCT04358809 | Unknown Phase 3 DMC

• 1 other identifier: CRSC20006
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of patients with increased disease severity

  To compare the difference in proportion of patients with increased disease severity

  From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

Secondary Outcomes (5)

• Incidence of adverse events and serious adverse events (Safety)

  Till day 28

• Number of COVID-19 patients discharged from hospital

  From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

• Number of COVID-19 patients transfer to ICU

  From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or 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 scale

  From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

• Number of of symptom free patients

  From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

Study Arms (2)

Suspension of Mw + Standard therapy of COVID-19

EXPERIMENTAL

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

Drug: Suspension of heat killed (autoclaved) Mycobacterium w

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Suspension of heat killed (autoclaved) Mycobacterium w DRUG

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

Suspension of Mw + Standard therapy of COVID-19

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead
• Council of Scientific and Industrial Research, India: collaborator

Study Sites (4)

All India Institute of Medical Science, Raipur

Raipur, Chhattisgarh, 492099, India

RECRUITING

All India Institute of Medical Sciences, Bhopal

Bhopal, India

RECRUITING

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012., India

RECRUITING

All India Institute of Medical Sciences, Delhi

Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sanjay Patel, MBBS

  Cadila Pharmaceuticals Limited

  STUDY CHAIR

Central Study Contacts

Anil Avhad, MBBS

CONTACT

919833454044; anil.avhad@cadilapharma.co.in

Ashish Amarsheda

CONTACT

919898073861; ashish.a@cadilapharma.co.in

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blinded, two arms, placebo controlled, clinical trial

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: June 30, 2020
• Primary Completion: February 28, 2021
• Study Completion: April 30, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)