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Effect of BCG Vaccine on Preventing COVID-19

Phase 3
Recruiting
Conditions
U07.1 COVI
Coronavirus Disease 2019 (COVID-19).
U07.1 COVID-19, virus identified
Registration Number
IRCT20200411047019N1
Lead Sponsor
Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Mdical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
500
Inclusion Criteria

Healthcare workers potentially exposed to patient with COVID-19 infection in hospitals
Over 18 years of age
Complete the consent form with date and signature
Male and female

Exclusion Criteria

Allergy to the BCG vaccine or any BCG vaccine contraindication
Fever (>38 C) within the past 24 hours or generalised skin diseases such as infection, eczema, dermatitis or psoriasis at or near the site of vaccination.
Pregnancy
Cases with active or latent Mycobacterium tuberculosis
Known HIV infection
Individuals with any serious underlying illness (such as malignancy) except those with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease if they are not immunocompromised
Live vaccine administered for 4 weeks prior to randomization
Suspected to active viral or bacterial infections
Individuals with a SARS-CoV-2 positive test result
Severely immunocompromised subject or who has taken immunosuppressive therapy in the last years

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
COVID-19 infection. Timepoint: Time Frame: At the beginning and weekly for up to 12 months. Method of measurement: A questionare for assessment of fever (>38), cough, shortness of breath, respiratory failure, runny / blocked nose and PCR or serology for detection of SARS-Cov-2.;Severe COVID-19 disease. Timepoint: Time Frame: At the beginning and weekly for up to 12 months. Method of measurement: A questionare to assess hospitalization or death due to covid-19 infection.
Secondary Outcome Measures
NameTimeMethod
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