Status:
UNKNOWN
Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination
Lead Sponsor:
Radboud University Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also been shown to induce protection against various infections with a viral aetiology, leading to significant re...
Detailed Description
On March 11 2020 the World Health Organization (WHO) declared the coronavirus (SARS-CoV-2) outbreak a pandemic. The number of confirmed cases continues to rise, leading to significant morbidity and mo...
Eligibility Criteria
Inclusion
- Adult (≥ 60 years)
Exclusion
- Fever (\>38 ºC) within the past 24 hours
- Suspicion of current active viral or bacterial infection
- Expected vaccination during the first three months of the study period
- 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
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
2014 Patients enrolled
Trial Details
Trial ID
NCT04417335
Start Date
April 16 2020
End Date
May 1 2021
Last Update
June 4 2020
Active Locations (2)
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1
Radboud University
Nijmegen, Gelderland, Netherlands, 6525 GA
2
UMC Utrecht
Utrecht, Netherlands, 3584 CX