COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04328441

Prof. M.J.M. Bonten

Thijs ten Doesschate, t.tendoesschate@umcutrecht.nl (PI email not reported)

2020-03-31

Completed

RCT

Randomized

Adaptive

Blind label

multi-center

Prevention

inclusion criteria: - adult (≥18 years) - male or female - hospital personnel (expected to) taking care for patients with sars cov-2 infection

- 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

2

UMC Utrecht

18

100

Netherlands

Health workers

N/A

1511

Health Care Workers absenteeism

None

Phase 3

[{"arm_notes": "", "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"}]