Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
NCT ID: NCT04353518
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
4000 participants
INTERVENTIONAL
2020-06-30
2021-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
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
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.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Council of Scientific and Industrial Research, India
OTHER_GOV
Cadila Pharnmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Anil Avhad, MBBS
Role: STUDY_CHAIR
Cadila Pharmaceuticals Limited
Locations
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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, , India
Countries
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Central Contacts
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Facility Contacts
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Sarman Singh, MD
Role: primary
Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
Role: primary
Sushma Bhatnagar, MD (Anaesthesiology)
Role: primary
Other Identifiers
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CRSC20005
Identifier Type: -
Identifier Source: org_study_id