E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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;
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E.4 | Principal 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-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. |
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E.5 End points |
E.5.1 | 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); |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Over the entire 18-month period following the inclusion in the study |
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E.5.2 | 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%. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From month 3. until the end of the study. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
The study aim is to collect data in order to determine whether vaccination against tuberculosis with BCG-10 has an impact on SARS-CoV-2 infection and COVID-19 (incidence, course of disease) The project is aimed to answer whether the tuberculosis vaccine produced and used for years in Poland induces an immune response allowing to counter viral infections, including SARS-CoV-2 in a pandemic ? BCG-10 vaccine used in the project has not been tested for inducing non-specific immunological effects. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |