Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
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|ClinicalTrials.gov Identifier: NCT04353518|
Recruitment Status : Not yet recruiting
First Posted : April 20, 2020
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Suspension of heat killed (autoclaved) Mycobacterium w Other: Placebo||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blind, two arms, placebo controlled, clinical trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
- 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
- Incidence of Adverse Event and Serious Adverse Event (safety and tolerability) [ Time Frame: Till 8 weeks ]Any AE / SAE observed during the study.
- 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.
- 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.
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
|Contact: Anil Avhad, MBBSfirstname.lastname@example.org|
|Contact: Sanjay Patel, MBBS||+912714221481 ext email@example.com|