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

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04353518
• Other study ID #: CRSC20005
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: April 2020
• Source: Cadila Pharnmaceuticals
• Contact: Sanjay Patel, MBBS
• Phone: +912714221481
• Email: sanjay.p[@]cadilapharma.co.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: May 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Mycobacterium Infections

Intervention

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.

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.

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences, Bhopal	Bhopal	Madhya Pradesh
India	Post Graduate Institute of Medical Education and Research	Chandigarh
India	All lndia Institute of Medical Science, Delhi	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Cadila Pharnmaceuticals	Council of Scientific and Industrial Research, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)	Any AE / SAE observed during the study.	Till 8 weeks
Secondary	Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms	Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.	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	Number of subject developing severe COVID-19 infection based on ordinal scale	Whether administration of Mw prevents development of severe COVID-19 infection.	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