BCG vaccination for healthcare workers in SARS-CoV-2 pandemic
- Conditions
- SARS-CoV-2, COVID19
- Registration Number
- NL-OMON27106
- Lead Sponsor
- niversity Medical Centre Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1500
Adult (=18 years);
- Male or female;
- Hospital personnel (expected to) taking care for patients with SARS-CoV-2 infection
- Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration;
- Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection;
- Fever (>38 C) within the past 24 hours
- Pregnancy;
- Suspicion of active viral or bacterial infection;
- Vaccination in the past 4 weeks or expected vaccination during the study period, independent 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 anti-cytokine therapies. i) 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;
- Direct involvement in the design or the execution of the BCG-CORONA study;
- Expected absence from work of =4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc);
- Employed to the hospital < 22 hours per week;
- Not in possession of a smartphone
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of days of unplanned absenteeism for any reason
- Secondary Outcome Measures
Name Time Method