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

NCT04353518 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2020-12-22

No results posted yet for this study

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.

Conditions

Interventions

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.

OTHER

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.

Sponsors & Collaborators

  • Council of Scientific and Industrial Research, India

    collaborator OTHER_GOV

  • Cadila Pharnmaceuticals

    lead INDUSTRY

Principal Investigators

  • Anil Avhad, MBBS · Cadila Pharmaceuticals Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-03-30
Completion
2021-05-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04353518 on ClinicalTrials.gov