Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland
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|ClinicalTrials.gov Identifier: NCT04648800|
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : December 2, 2020
Countries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes.
The aim of the study is to answer the following questions:
- Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)?
- Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects?
- Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result?
A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of TB skin test/anti-SARS-CoV-2 IgG test/serum banking*; V3: TB skin test (TST) interpretation and subjects' division into three groups: (I) positive TST - observation; (II) negative TST- BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on randomisation; V4: serum banking*. Parallel beginning from V3, weekly telephone monitoring participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm SARS-CoV-2 infection + serum banking*. V5: 3 months after vaccination at the end of the study: history/anti-SARS-CoV-2 IgG test, serum banking*.
Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST + observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should demonstrate whether mass BCG vaccination has an impact on the incidence and course of COVID-19.
* to measure the level of cytokines involved in cell-mediated immunity process
|Condition or disease||Intervention/treatment||Phase|
|Covid19 BCG Vaccination Reaction SARS-CoV Infection||Drug: BCG-10 vaccine Drug: 0.9% saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
Due to trial blindness, the team (a doctor and nurse) participating in visits 2 (V2) and 3 (V3) (as unblinded staff) is excluded from further contacts with trial subjects and from participating in the trial.
After the visit, the investigator enters its results into the medical documentation and the e-CRF system.
In the medical records of visit 3 (written and electronic), the result of randomization is not disclosed.
After visit 3, the division of subjects into Groups II and III (randomisation) is recorded only in separate written records; the physician participating in visit 2 and 3 sends the documentation to the leading centre after the end of visit 3, where it is stored and fully protected against access of blinded personnel.
The subject must not be informed about the group he/she belongs to.
|Official Title:||A Multi-centre, Randomised, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland|
|Actual Study Start Date :||July 7, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||April 2021|
No Intervention: Group I
with positive RT23 test reading, not randomised and not vaccinated against tuberculosis
Active Comparator: Group II
with negative RT23 test reading, receiving BCG-10 Vaccine
Drug: BCG-10 vaccine
The BCG-10 anti-tuberculosis vaccine
Placebo Comparator: Group III
with negative RT23 test reading, receiving placebo
Drug: 0.9% saline
- death and life- or health-threatening condition (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe renal failure, stroke/transient cerebral ischaemia) [ Time Frame: throughout the period of 18 months from inclusion ]
- shock - when catecholamines are required despite initial fluid resuscitation
- severe respiratory failure - the need for non-invasive or invasive ventilation
- severe renal failure - the need for renal replacement therapy (for undialysed individuals, i.e. with end-stage renal failure (ESRD)
- Onset of clinical symptoms of COVID-19 [ Time Frame: 12 weeks from the date of the third visit - V3 ]Present symptoms (determined in the Telephone Contact Card) appear to indicate a possible SARS-CovV-2 infection
- asymptomatic SARS-CovV-2 infection [ Time Frame: 12 weeks from the date of the third visit - V3 ]based on anti SARS-CoV-2 IgG serological tests
- Hospitalisation [ Time Frame: 12 weeks from the date of the third visit - V3 ]the need for hospitalisation and its duration
- ICU Hospitalisation [ Time Frame: 12 weeks from the date of the third visit - V3 ]the need for hospitalisation in the ICU and its duration
- Dyspnoea [ Time Frame: 12 weeks from the date of the third visit - V3 ]requiring passive oxygen therapy to eliminate the symptom or maintain saturation >92%
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648800
|Contact: Artur Mazur, prof.||+48 17 872 11 firstname.lastname@example.org|
|Contact: Hanna Czajka, email@example.com|
|Department of Anesthesiology and Intensive Care, University Clinical Center, School of Medicine in Katowice, Medical University of Silesia||Recruiting|
|Contact: Łukasz J. Krzych, prof.|
|Principal Investigator: Łukasz J. Krzych, prof|
|Stefan Żeromski Specialist Hospital||Recruiting|
|Contact: Lidia Stopyra, dr|
|Principal Investigator: Lidia Stopyra|
|Voivodeship Hospital nr 2 in the Name of The Saint Queen Jadwiga, University of Rzeszów, Poland||Recruiting|
|Rzeszów, Poland, 35-959|
|Contact: Anna Darmochwał-Kolarz, prof.|
|Principal Investigator: Anna Darmochwał-Kolarz, prof|
|Saint Jadwiga Śląska Hospital||Recruiting|
|Contact: Henryk Szymański, prof.|
|Principal Investigator: Henryk Szymański, prof|
|Department of Pediatrics, Bielanski Hospital,||Recruiting|
|Contact: Teresa Jackowska, prof.|
|Principal Investigator: Teresa Jackowska, prof.|
|Contact: Igor Radziewicz-Winnicki, dr|
|Principal Investigator: Igor Radziewicz-Winnicki, dr|
|Principal Investigator:||Hanna Czajka, prof.||College of Medical Sciences, University of Rzeszów|