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

A multi-centre, randomised, double-blind, placebo-controlled phase III study assessing the impact of BCG vaccination on the incidence and course of SARS-CoV-2 infection among healthcare workers in Poland during the COVID-19 pandemic.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002111-22-PL

Enrollment

1000

Registered

2020-04-29

Start date

2020-06-26

Completion date

Unknown

Last updated

2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

not applicable

Interventions

Trade Name: Anti-Tuberculosis Vaccine BCG 10 Pharmaceutical Form: Powder and solvent for suspension for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) To confirm that, after additional BCG vaccination, there are fewer COVID-19 cases and deaths among subjects with negative RT23 test, and that these subjects present milder course of SARS CoV-2 infection than those who have not been vaccinated with BCG; 2) To confirm that among people with a positive RT23 test, previously vaccinated with tuberculosis vaccine, there is a lower morbidity and mortality resulting from COVID-19 infection, and that these subjects have a milder course of this disease than people with a negative RT23 test who have not received a vaccine against tuberculosis;Secondary Objective: 1) to examine whether the percentage of positive RT23 tests in the four examined provinces remains in correlation with the number of COVID-19 cases in those provinces? 2) to examine whether the presence of a scar or scars from previous BCG vaccination has an impact on the course of SARS-CoV-2 infection? 3) to ascertain whether the time since the last BCG vaccination has an influence on the occurrence and course of COVID-19?;Primary end point(s): - death or life-threatening / severe health impairment (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe kidney failure, stroke / transient ischemic attack);;Timepoint(s) of evaluation of this end point: Over the entire 18-month period following the inclusion in the study	—

Measure

Time frame

Main Objective: 1) To confirm that, after additional BCG vaccination, there are fewer COVID-19 cases and deaths among subjects with negative RT23 test, and that these subjects present milder course of SARS CoV-2 infection than those who have not been vaccinated with BCG; 2) To confirm that among people with a positive RT23 test, previously vaccinated with tuberculosis vaccine, there is a lower morbidity and mortality resulting from COVID-19 infection, and that these subjects have a milder course of this disease than people with a negative RT23 test who have not received a vaccine against tuberculosis;Secondary Objective: 1) to examine whether the percentage of positive RT23 tests in the four examined provinces remains in correlation with the number of COVID-19 cases in those provinces? 2) to examine whether the presence of a scar or scars from previous BCG vaccination has an impact on the course of SARS-CoV-2 infection? 3) to ascertain whether the time since the last BCG vaccination has an influence on the occurrence and course of COVID-19?;Primary end point(s): - death or life-threatening / severe health impairment (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe kidney failure, stroke / transient ischemic attack);;Timepoint(s) of evaluation of this end point: Over the entire 18-month period following the inclusion in the study

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Secondary

Measure	Time frame
Secondary end point(s): - occurrence of clinical signs of COVID-19 (according to protocol), - the diagnosis of asymptomatic SARS-CoV-2 infection (based on IgG anti-SARS-CoV-2 serological tests) - the need for hospitalization and its duration, - the need for hospitalization in the intensive care unit and its duration, - dyspnea with the need for oxygen therapy to eliminate the symptom or maintain saturation >92%.;Timepoint(s) of evaluation of this end point: From month 3. until the end of the study.	—

Measure

Time frame

Secondary end point(s): - occurrence of clinical signs of COVID-19 (according to protocol), - the diagnosis of asymptomatic SARS-CoV-2 infection (based on IgG anti-SARS-CoV-2 serological tests) - the need for hospitalization and its duration, - the need for hospitalization in the intensive care unit and its duration, - dyspnea with the need for oxygen therapy to eliminate the symptom or maintain saturation >92%.;Timepoint(s) of evaluation of this end point: From month 3. until the end of the study.

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Countries

Poland

Contacts

Public ContactNational Study Coordinator

University of Rzeszów Faculty of Medicine

hanna.czajka@onet.pl+48601990398

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026