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

NCT04648800 | Unknown Phase 3 DMC

• 2 other identifiers: BCG/COVID-19/UR/04/20202020-002111-22
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 6

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. 1.Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)?
2. 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. 3.Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result?

Conditions

Covid19; BCG Vaccination Reaction; SARS-CoV Infection

Keywords

Covid19; BCG Vaccination; SARS-CoV Infection; BCG vaccine

Outcome Measures

Primary Outcomes (1)

• death and life- or health-threatening condition (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe renal failure, stroke/transient cerebral ischaemia)

  * 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)

  throughout the period of 18 months from inclusion

Secondary Outcomes (5)

• Onset of clinical symptoms of COVID-19

  12 weeks from the date of the third visit - V3

• asymptomatic SARS-CovV-2 infection

  12 weeks from the date of the third visit - V3

• Hospitalisation

  12 weeks from the date of the third visit - V3

• ICU Hospitalisation

  12 weeks from the date of the third visit - V3

• Dyspnoea

  12 weeks from the date of the third visit - V3

Study Arms (3)

Group I

NO INTERVENTION

with positive RT23 test reading, not randomised and not vaccinated against tuberculosis

Group II

ACTIVE COMPARATOR

with negative RT23 test reading, receiving BCG-10 Vaccine

Drug: BCG-10 vaccine

Group III

PLACEBO COMPARATOR

with negative RT23 test reading, receiving placebo

Drug: 0.9% saline

Interventions

BCG-10 vaccine DRUG

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.

Group II

0.9% saline DRUG

0.9% saline

Group III

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Hanna Czajka: lead
• Medical Research Agency, Poland: collaborator

Study Sites (6)

Department of Anesthesiology and Intensive Care, University Clinical Center, School of Medicine in Katowice, Medical University of Silesia

Katowice, Poland

RECRUITING

Stefan Żeromski Specialist Hospital

Krakow, Poland

RECRUITING

Voivodeship Hospital nr 2 in the Name of The Saint Queen Jadwiga, University of Rzeszów, Poland

Rzeszów, 35-959, Poland

RECRUITING

Saint Jadwiga Śląska Hospital

Trzebnica, Poland

RECRUITING

Department of Pediatrics, Bielanski Hospital,

Warsaw, Poland

RECRUITING

Praski Hospital

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hanna Czajka, prof.

  College of Medical Sciences, University of Rzeszów

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Artur Mazur, prof.

CONTACT

+48 17 872 11 53; prorektor.cm@ur.edu.pl

Hanna Czajka, prof.

CONTACT

hanna.czajka@onet.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: National Project Coordinator

Model Details: * 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

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: December 2, 2020
• Study Start: July 7, 2020
• Primary Completion: December 1, 2020
• Study Completion: April 1, 2021
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

PL (6)