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IRCT20200411047019N1 IRCT 2020-05-18 Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Mdical Sciences Effect of BCG Vaccine on Preventing COVID-19 Investigating the Effect of BCG Vaccine on Preventing COVID-19 Infection in Healthcare Staff Exposed to SARS-CoV-2 2020-06-04 anticipated 500 Complete https://irct.ir/trial/47279 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization will be used and the size of the blocks will be selected randomly (for example 8 or 6 participants in each block with an equal number of two groups). In this method, the blocks are determined based on the hospital health care workers information that is in the face of covid 19. In each block, half of the people are considered as intervention groups and the rest half as placebo. The main goal of this method is to balance the number of participants in each group, Blinding description: Statistical data analyst will distribute the health care workers in randomized blocks using software in two groups including vaccine recipients and placebo. Identical vials without specifications (vials A and B) will be given to nurses for injection. -Participants won't be aware of the injection material. Individuals who won't be aware of the grouping are as follow: -Individuals who receive feedback from participants about influenza-like illness or severe respiratory illness. -People who perform PCR tests to diagnose the coronavirus. -Personnel and researchers who complete information based on questionnaires and register in SPSS software. The final analysis will be performed by the statistical analyst who is informed of the grouping. 3 Coronavirus Disease 2019 (COVID-19). 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 participants will be followed-up for 12 months by text messages (up to weekly). The Mantoux Tuberculin skin test (before receiving the BCG vaccine) will be performed by intradermal injection of 0.1 ml (PPD) in front of the left forearm. This test will be read after 48-72 hours, a positive tuberculin test is 10 mm or more. Blood samples will be collected at the beginning and 12 months for PCR and antibody detection. Intervention 2: Control 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 participants will be followed-up for 12 months by text messages (up to weekly). The Mantoux Tuberculin skin test (before receiving the BCG vaccine) will be performed by intradermal injection of 0.1 ml (PPD) in front of the left forearm. This test will be read after 48-72 hours, a positive tuberculin test is 10 mm or more. Blood samples will be collected at the beginning and 12 months for PCR and antibody detection. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD will be shared. When: The data will become available starting 6 months after publication for 1 year. To whom: It will be available for people working in academic institutions. Conditions: The data will be shared by request and the persons who are responsible for general and scientific inequires will review the request. Where to obtain: person who are responsible for general inequires: Bahman Pourabbas bpourabbas@yahoo.com person who are responsible for scientific inequires: Gholamreza Pouladfar pouladfar_ghr@hotmail.com How to obtain: The academic applicants should send their request by email. The responsible persons will answer up to 2 weeks. Comments:
public Bahman Pourabbas
Prof. Alborzi Clinical Microbiology Research Center - Nemazi Hospital- Zand St.- ُShiraz - Iran
شیراز Iran (Islamic Republic of) 7193613311 +98 71 3647 4304 pourabbasb@sums.ac.ir Shiraz University of Medical Sciences scientific Gholamreza Pouladfar
Clinical Microbiology Research Center- Nemazi hospital- Zand st.
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3647 4304 pouladfar_ghr@hotmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both 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 U07.1 COVI U07.1 COVID-19, virus identified Prevention Placebo 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 participants will be followed-up for 12 months by text messages (up to weekly). The Mantoux Tuberculin skin test (before receiving the BCG vaccine) will be performed by intradermal injection of 0.1 ml (PPD) in front of the left forearm. This test will be read after 48-72 hours, a positive tuberculin test is 10 mm or more. Blood samples will be collected at the beginning and 12 months for PCR and antibody detection. Control 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 participants will be followed-up for 12 months by text messages (up to weekly). The Mantoux Tuberculin skin test (before receiving the BCG vaccine) will be performed by intradermal injection of 0.1 ml (PPD) in front of the left forearm. This test will be read after 48-72 hours, a positive tuberculin test is 10 mm or more. Blood samples will be collected at the beginning and 12 months for PCR and antibody detection. 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. 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. Shiraz University of Medical Sciences Approved 2020-05-20 Ethics committee of Shiraz university of medical sciences Clinical Microbiology Research center, Nemazi Hospital, Zand St,Zand St. Shiraz Fars Iran (Islamic Republic of)