Clinical trial NCT04353518: Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Council of Scientific and Industrial Research, India
First posted: 2020-04-20
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, two arms, placebo controlled, clinical trial
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of subject acquiring COVID-19 infection
timeFrame: 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:
measure: Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
timeFrame: Till 8 weeks
measure: Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
timeFrame: 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.
measure: Number of subject developing severe COVID-19 infection based on ordinal scale
timeFrame: 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
Other outcomes:
Locations:
city: Bhopal
country: India
facility: All India Institute of Medical Sciences, Bhopal
state: Madhya Pradesh
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
city: Delhi
country: India
facility: All lndia Institute of Medical Science, Delhi
Study officials:
affiliation: Cadila Pharmaceuticals Limited
name: Anil Avhad, MBBS
role: STUDY_CHAIR
References: