Status:
COMPLETED
Reducing Health Care Workers Absenteeism in Covid-19 Pandemic Through BCG Vaccine
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Radboud University Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Rationale: Covid-19 spreads rapidly throughout the world. A large epidemic in the Netherlands would seriously challenge the available hospital capacity, and this would be augmented by absenteeism of h...
Detailed Description
Since the beginning of 2020, SARS-CoV-2 spread rapidly throughout China and the rest of the world, with on 27 February 2020 the first detected case in the Netherlands. According to the WHO, Health-ca...
Eligibility Criteria
Inclusion
- Adult (≥18 years)
- Male or female
- Hospital personnel (expected to) taking care for patients with SARS CoV-2 infection
Exclusion
- 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
Key Trial Info
Start Date :
March 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
1511 Patients enrolled
Trial Details
Trial ID
NCT04328441
Start Date
March 25 2020
End Date
March 31 2021
Last Update
June 3 2022
Active Locations (9)
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1
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
2
Radboud UMC
Nijmegen, Gelderland, Netherlands
3
Sint Maartenskliniek
Nijmegen, Gelderland, Netherlands
4
Jeroen Bosch ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands