COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002111-22/PL

University of Rzeszów Faculty of Medicine - National Study Coordinator

hanna.czajka@onet.pl

2020-04-29

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

- health care worker (doctor, nurse, midwife, paramedic, laboratory diagnostician or other person having direct contact with a patient) in the age group >25 years, - no confirmed SARS-CoV-2 infection history, - informed consent to participate in the study and consent to the processing of personal data, - declared availability for telephone contact throughout the study period, - good state of health, - previously performed vaccination against tuberculosis,

- hypersensitivity to any component of BCG-10 vaccine, - hypersensitivity to previously administered tuberculin (local lesions, skin lesions, skin necrosis, blisters, other severe skin reactions at the site of administration), - HIV infection (confirmed or suspected infections, even if asymptomatic), - primary or secondary immunodeficiencies (including those with gamma-interferon deficiency or Di George syndrome), - radiotherapy (less than 24 months before the date of inclusion) , - treatment with corticosteroids during immunosuppressive therapy (including treatment with monoclonal anti-TNF-α antibodies such as infliximab) - less than 24 months before the date of inclusion, - cancer (e.g. leukaemia, Hodgkin's disease, lymphoma or other reticuloendothelial neoplasms) - after hematopoietic stem cell transplantation and organ transplantation, - in the exacerbation phase of chronic diseases (including severe malnutrition), - pregnancy, - suffered from tuberculosis, - keloidal scar at the site of vaccination after previous BCG vaccination.

2

University of Rzeszów

18

65

Poland

Health workers

N/A

1000

- death or life-threatening / severe health impairment (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe kidney failure, stroke / transient ischemic attack),

Declared number of arm (4.0) 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"}]