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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Suspension of heat killed (autoclaved) Mycobacterium w
Placebo
Sponsored by
Cadila Pharnmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • All India Institute of Medical Sciences, BhopalRecruiting
  • Post Graduate Institute of Medical Education and ResearchRecruiting
  • All lndia Institute of Medical Science, DelhiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suspension of Mw

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
Any AE / SAE observed during the study.
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.
Number of subject developing severe COVID-19 infection based on ordinal scale
Whether administration of Mw prevents development of severe COVID-19 infection.

Full Information

First Posted
April 16, 2020
Last Updated
December 20, 2020
Sponsor
Cadila Pharnmaceuticals
Collaborators
Council of Scientific and Industrial Research, India
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1. Study Identification

Unique Protocol Identification Number
NCT04353518
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cadila Pharnmaceuticals
Collaborators
Council of Scientific and Industrial Research, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, two arms, placebo controlled, clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suspension of Mw
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Suspension of heat killed (autoclaved) Mycobacterium w
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of subject acquiring COVID-19 infection
Description
To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose
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..
Secondary Outcome Measure Information:
Title
Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
Description
Any AE / SAE observed during the study.
Time Frame
Till 8 weeks
Title
Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
Description
Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.
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.
Title
Number of subject developing severe COVID-19 infection based on ordinal scale
Description
Whether administration of Mw prevents development of severe 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjay Patel, MBBS
Phone
+912714221481
Ext
270
Email
sanjay.p@cadilapharma.co.in
First Name & Middle Initial & Last Name or Official Title & Degree
Ashish Amarsheda, M.Pharm
Phone
+919898073861
Email
ashish.a@cadilapharma.co.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Avhad, MBBS
Organizational Affiliation
Cadila Pharmaceuticals Limited
Official's Role
Study Chair
Facility Information:
Facility Name
All India Institute of Medical Sciences, Bhopal
City
Bhopal
State/Province
Madhya Pradesh
ZIP/Postal Code
462024
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarman Singh, MD
Phone
917552672317
Email
director@aiimsbhopal.edu.in
First Name & Middle Initial & Last Name & Degree
Sarman Singh, MD
Facility Name
Post Graduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012.
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
Phone
01722756823
Email
inderpgi@outlook.com
First Name & Middle Initial & Last Name & Degree
Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
Facility Name
All lndia Institute of Medical Science, Delhi
City
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sushma Bhatnagar, MD (Anaesthesiology)
Phone
919811326453
Email
sushmabhatnagar1@gmail.com
First Name & Middle Initial & Last Name & Degree
Sushma Bhatnagar, MD (Anaesthesiology)

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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