Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19

NCT04353518 | Unknown Phase 3 DMC

• 1 other identifier: CRSC20005
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of subject acquiring COVID-19 infection

  To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose

  From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..

Secondary Outcomes (3)

• Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)

  Till 8 weeks

• Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms

  From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.

• Number of subject developing severe COVID-19 infection based on ordinal scale

  From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing

Study Arms (2)

Suspension of Mw

EXPERIMENTAL

Intradermal suspension of Mw will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal Mw in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal Mw administered.

Drug: Suspension of heat killed (autoclaved) Mycobacterium w

Placebo

PLACEBO COMPARATOR

Placebo will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal placebo in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal placebo.

Other: Placebo

Interventions

Suspension of heat killed (autoclaved) Mycobacterium w DRUG

Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.

Suspension of Mw

Placebo OTHER

Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
• Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
• Female subject 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 months post-dosing.
• The subject 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:

• Any febrile illness with oral temperature \> 100°F within 3 days prior to randomization.
• Subject with past history of COVID-19 infection.
• Pregnant and / or lactating female subjects.
• Presence of any illness requiring hospital referral.
• Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
• History of allergic reactions or anaphylaxis to Mw or its component.

Sponsors & Collaborators

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

Study Sites (3)

All India Institute of Medical Sciences, Bhopal

Bhopal, Madhya Pradesh, 462024, India

RECRUITING

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012., India

RECRUITING

All lndia Institute of Medical Science, 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

• Anil Avhad, MBBS

  Cadila Pharmaceuticals Limited

  STUDY CHAIR

Central Study Contacts

Sanjay Patel, MBBS

CONTACT

+912714221481; sanjay.p@cadilapharma.co.in

Ashish Amarsheda, M.Pharm

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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, two arms, placebo controlled, clinical trial

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: June 30, 2020
• Primary Completion: March 30, 2021
• Study Completion: May 30, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)