COVID-19 trials registries data warehouse

https://trialregister.nl/trial/8547

Simone Moorlag

Simone.Moorlag@radboudumc.nl

2020-04-22

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

• 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

Radboudumc

60

None

Netherlands

Healthy volunteers

N/A

1600

• SARS-CoV-2 related hospital admission

Not reported

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