COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001888-90/DK

University of Southern Denmark - Clinical Institute, OPEN

open.adm@rsyd.dk

2020-04-16

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

Adult (≥18 years), Hospital personnel working at one of the participating hospitals.

Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration, Known active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species, Previous M. tuberculosis infection, Previous confirmed COVID-19 infection, Fever (>38 C) within the past 24 hours, Suspicion of active viral or bacterial infection, Pregnancy, Breastfeeding, Vaccination with other live attenuated vaccine within the last 4 weeks, Severely immunocompromised subjects. This exclusion category comprises a) subjects with known infection by the human immunodeficiency virus (HIV-1), b) subjects with solid organ transplantation, c) subjects with bone marrow transplantation, d) subjects under chemotherapy, e) subjects with primary immunodeficiency, f) treatment with any anti-cytokine therapies. g) treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months, Active solid or non-solid malignancy or lymphoma within the prior two years, Direct involvement in the design or the execution of the BCG-DENMARK-COVID study, Employed to the hospital < 22 hours per week.

2

University of Southern Denmark

18

100

Denmark

Healthy volunteers

N/A

1500

Number of days of unplanned absenteeism for any reason.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 3

[{"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"}]