Coronavirus Disease 2019 (COVID-19). U07.1 COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: Healthcare workers who are exposed to the pandemic virus (COVID-19) will be randomly assigned to receive 0.1 ml intradermal injection of BCG vaccine. All participa
Sponsors
Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Mdical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Hospital admission duration due to SARS-CoV-2. Timepoint: At the beginning and weekly for up to 12 months. Method of measurement: Review of hospital records.;Hospital admission due to documented SARS-CoV-2 infection. Timepoint: Review of hospital records. Method of measurement: Incidnce of hospitalization days due to documented SARS-CoV-2 infection.;Pneumonia. Timepoint: At the beginning and weekly for up to 12 months. Method of measurement: Number of pneumonia cases with abnormal chest X-rays or CT scan and evaluation the extent of lung involvement.;Mechanical ventilation duration with SARS-CoV-2. Timepoint: At the beginning and weekly for up to 12 months. Method of measurement: Review of hospital records.;ICU admission duration due to SARS-CoV-2. Timepoint: At the beginning and weekly for up to 12 months. Method of measurement: Review of hospital records.;Mechanical ventilation usage in patients with SARS-CoV-2. Timepoint: At the beginning and weekly for up to 12 months. Method of measurement: Review of hospital records.;Number of days absence at work due to febrile respiratory illness. Timepoint: At the beginning and weekly for up to 12 months. Method of measurement: self-reporting.;Seroconversion of SARS-CoV-2-specific antibodies (IgM,G). Timepoint: At the beginning, during the study (if symptoms occurs) and at 12 months. Method of measurement: Measurement of plasma/serum SARS-CoV-2-specific antibodies (IgM,G) at vaccination time and also the end of the study period.;Intensive care unit admission due to documented SARS-CoV-2 infection. Timepoint: At the beginning and weekly for up to 12 months. Method of measurement: Review of hospital records. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBahman Pourabbas
Shiraz University of Medical Sciences
Outcome results
None listed