Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04353518
Recruitment Status : Not yet recruiting
First Posted : April 20, 2020
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
Council of Scientific and Industrial Research, India
Information provided by (Responsible Party):
Cadila Pharnmaceuticals

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Suspension of heat killed (autoclaved) Mycobacterium w Other: Placebo Phase 3

Detailed Description:

Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria.

Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered.

Study duration for each subject will be of 8 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, two arms, placebo controlled, clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Two Arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19.
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Suspension of Mw

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
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.

Placebo Comparator: Placebo

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
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.




Primary Outcome Measures :
  1. Number of subject acquiring COVID-19 infection [ Time Frame: 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.. ]
    To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose


Secondary Outcome Measures :
  1. Incidence of Adverse Event and Serious Adverse Event (safety and tolerability) [ Time Frame: Till 8 weeks ]
    Any AE / SAE observed during the study.

  2. Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms [ Time Frame: 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. ]
    Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.

  3. Number of subject developing severe COVID-19 infection based on ordinal scale [ Time Frame: 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 ]
    Whether administration of Mw prevents development of severe COVID-19 infection.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353518


Contacts
Layout table for location contacts
Contact: Anil Avhad, MBBS 919833454044 anil.avhad@cadilapharma.co.in
Contact: Sanjay Patel, MBBS +912714221481 ext 270 sanjay.p@cadilapharma.co.in

Sponsors and Collaborators
Cadila Pharnmaceuticals
Council of Scientific and Industrial Research, India
Layout table for additonal information
Responsible Party: Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier: NCT04353518    
Other Study ID Numbers: CRSC20005
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections