COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04417335

Radboud University

Not reported

2020-06-04

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - adult (≥ 60 years)

- 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

2

Radboud University Medical Center

60

100

Netherlands

Healthy volunteers

N/A

2014

SARS-CoV-2 related hospital admission

None

Phase 4

[{"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]