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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
Sponsor:
Collaborator:
Medical Research Agency - Agencja Badań Medycznych
Information provided by (Responsible Party):
Hanna Czajka, University of Rzeszow

Brief Summary:

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:

  1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)?
  2. 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?
  3. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Running the RT 23 test (visit No.2 - V2)
  • RT23 test reading and BCG -10 vaccination (visit No. 3-V3):

Positive subjects:

  1. assigned to Group I, not randomised and not vaccinated against tuberculosis
  2. when the RT23 test indicates a strongly positive result /induration diameter > 15 mm/, the subject is informed to contact his/her family doctor to obtain a referral to a pulmonary outpatient clinic

Negative subjects:

  1. undergo a physical examination before vaccination performed by the doctor (investigator)
  2. are remotely randomised by the e-CRF IT system to Group II receiving BCG-10 or to placebo Group III (control). The subject must not be informed about the group he/she belongs to receive BCG-10 or a placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

  • powder and solvent for preparing a suspension for intradermal injections of Vaccinum tuberculosis (BCG) cryodesiccatum;
  • lyophilised BCG vaccine
  • one dose (0.1 ml) contains 50 micrograms of half-dried mass of BCG mycobacteria, which corresponds to 150,000 - 600,000 of live BCG bacilli- the Brazilian Moreau sub-strain.

Placebo Comparator: Group III
with negative RT23 test reading, receiving placebo
Drug: 0.9% saline
0.9% saline




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Hospitalisation [ Time Frame: 12 weeks from the date of the third visit - V3 ]
    the need for hospitalisation and its duration

  4. ICU Hospitalisation [ Time Frame: 12 weeks from the date of the third visit - V3 ]
    the need for hospitalisation in the ICU and its duration

  5. 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%



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Artur Mazur, prof. +48 17 872 11 53 prorektor.cm@ur.edu.pl
Contact: Hanna Czajka, prof. hanna.czajka@onet.pl

Locations
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Poland
Department of Anesthesiology and Intensive Care, University Clinical Center, School of Medicine in Katowice, Medical University of Silesia Recruiting
Katowice, Poland
Contact: Łukasz J. Krzych, prof.         
Principal Investigator: Łukasz J. Krzych, prof         
Stefan Żeromski Specialist Hospital Recruiting
Kraków, Poland
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
Trzebnica, Poland
Contact: Henryk Szymański, prof.         
Principal Investigator: Henryk Szymański, prof         
Department of Pediatrics, Bielanski Hospital, Recruiting
Warsaw, Poland
Contact: Teresa Jackowska, prof.         
Principal Investigator: Teresa Jackowska, prof.         
Praski Hospital Recruiting
Warsaw, Poland
Contact: Igor Radziewicz-Winnicki, dr         
Principal Investigator: Igor Radziewicz-Winnicki, dr         
Sponsors and Collaborators
Hanna Czajka
Medical Research Agency - Agencja Badań Medycznych
Investigators
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Principal Investigator: Hanna Czajka, prof. College of Medical Sciences, University of Rzeszów
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Responsible Party: Hanna Czajka, National Project Coordinator, University of Rzeszow
ClinicalTrials.gov Identifier: NCT04648800    
Other Study ID Numbers: BCG/COVID-19/UR/04/2020
2020-002111-22 ( EudraCT Number )
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hanna Czajka, University of Rzeszow:
Covid19
BCG Vaccination
SARS-CoV Infection
BCG vaccine
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases