NL-OMON49238CompletedPhase 4
Reducing hospital admission of elderly in SARS-CoV-2 pandemic via the induction of trained immunity by bacillus Calmette-Guérin vaccination, a randomized controlled trial. - BCG-CORONA-ELDERLY
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 2,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet the
- •following criteria:
- •Adult (>= 60 years)
- •Written informed consent
Exclusion Criteria
- •Fever (>38 ºC) within the past 24 hours
- •Suspicion of current active viral or bacterial infection
- •- Vaccination within 3 months of start studyperiod
- •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
Investigators
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