- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04353518
Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Sanjay Patel, MBBS
- Phone Number: 270 +912714221481
- Email: sanjay.p@cadilapharma.co.in
Study Contact Backup
- Name: Ashish Amarsheda, M.Pharm
- Phone Number: +919898073861
- Email: ashish.a@cadilapharma.co.in
Study Locations
-
-
-
Chandigarh, India, 160012.
- Recruiting
- Post Graduate Institute of Medical Education and Research
-
Contact:
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
- Phone Number: 01722756823
- Email: inderpgi@outlook.com
-
Principal Investigator:
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
-
Delhi, India, 110029
- Recruiting
- All lndia Institute of Medical Science, Delhi
-
Contact:
- Sushma Bhatnagar, MD (Anaesthesiology)
- Phone Number: 919811326453
- Email: sushmabhatnagar1@gmail.com
-
Principal Investigator:
- Sushma Bhatnagar, MD (Anaesthesiology)
-
-
Madhya Pradesh
-
Bhopal, Madhya Pradesh, India, 462024
- Recruiting
- All India Institute of Medical Sciences, Bhopal
-
Contact:
- Sarman Singh, MD
- Phone Number: 917552672317
- Email: director@aiimsbhopal.edu.in
-
Principal Investigator:
- Sarman Singh, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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. |
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
Time Frame: Till 8 weeks
|
Any AE / SAE observed during the study.
|
Till 8 weeks
|
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.
|
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
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.
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Anil Avhad, MBBS, Cadila Pharmaceuticals Limited
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRSC20005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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