Study evaluating the impact of BCG vaccination on the incidence and course of SARS-CoV-2 infection among health care workers in Poland during the COVID-19 pandemic

Phase 1

• Conditions: not applicable; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-002111-22-PL
• Lead Sponsor: niversity of Rzeszów

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-29
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

- 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;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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-a 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified