COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04648800

Artur Mazur, prof.

prorektor.cm@ur.edu.pl

2020-12-02

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - a health care professional (physician, nurse, midwife, paramedic, electroradiology technician, laboratory diagnostician, physiotherapist, nutritionist, orderly) aged >25 years - no confirmed sars-cov-2 infection - informed consent to participate in the trial and consent to personal data processing - declared availability for telephone contacts throughout the study period - good health condition - earlier vaccination against tuberculosis

- hypersensitivity to any component of bcg-10 - hypersensitivity to previously administered tuberculin (local skin lesions, necrosis of the skin, blisters, other severe skin reactions at the injection site) - hiv infection (confirmed or suspected infections, even if they are asymptomatic) - primary or secondary immunodeficiencies (including interferon - gamma deficiency or digeorge syndrome) - radiotherapy (less than 24 months before the date of inclusion in the trial - treatment with corticosteroids, ongoing immunosuppressive therapy (including those treated with monoclonal antibodies to tnf-α, such as infliximab) - less than 24 months before the date of inclusion in the trial - neoplastic diseases (e.g. leukaemia, malignant granuloma, lymphoma or some other cancer of the reticuloendothelial system) - less than 24 months before the date of inclusion in the study - after stem cell transplantation and organ transplantation - in the exacerbation stage of chronic diseases (including severe malnutrition) - pregnancy - history of tuberculosis - keloid at the vaccination site after previous bcg vaccination

3

Hanna Czajka

25

100

Poland

Health workers

N/A

1000

death and life- or health-threatening condition (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe renal failure, stroke/transient cerebral ischaemia)

None

Phase 3

[{"arm_notes": "", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]