COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001783-28/HU

National Korányi Institute of Pulmonology - Directorate

igazgatosag@koranyi.hu

2020-04-29

Completed

RCT

Randomized

Parallel

Open label

multi-center

Prevention

In order to be eligible to participate in this study, a subject must meet the following criteria: Adult (>18 years) Healthcare worker with direct contact with COVID-19 positive patients Written informed consent

A potential subject who meets any of the following criteria will be excluded from participation in this study: Fever (>37,5 ºC) within the past 24 hours Suspicion of current active viral or bacterial infection Expected vaccination during the study period, independently 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 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

National Korányi Institute of Pulmonology

18

100

Hungary

Health workers

N/A

1000

Primary End Point (repeat as necessary) Number of days of unplanned absenteeism because of documented COVID-19 infection

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"}]