EUCTR2020-001783-28-HU
Active, not recruiting
Phase 1
REDUCING ABSENCE FROM WORK OF HEALTHCARE WORKERS DUE TO COVID-19 INFECTION BY BCG (BACILLUS CALMETTE-GUÉRIN) VACCINATION - BACH (BCG Against COVID-19 in Hunga
ational Korányi Institute of Pulmonology0 sites1,000 target enrollmentApril 29, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Korányi Institute of Pulmonology
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet the following criteria:
- •Adult (\>18 years)
- •Healthcare worker with direct contact with COVID\-19 positive patients
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 950
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Fever (\>37,5 ºC) within the past 24 hours
- •Suspicion of current active viral or bacterial infection
- •Expected vaccination during the study period, independently of the type of vaccination.
- •Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV\-1\); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any immunosuppressant drugs such as anti\-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks
- •Active solid or non\-solid malignancy or lymphoma within the prior two years
- •Active participation in another research study that involves BCG administration
Outcomes
Primary Outcomes
Not specified
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