Randomized controlled trial evaluating the efficacy of vaccination with Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 via the strengthening of innate immunity in Health Care Workers.”COVID-BCG
- Conditions
- COVID 19Health care workers (medical or non-medical) in French hospitals in direct contact with COVID-19 patients, including nurses, medical doctors and other personnel working in wards in charge of COVID-19 patients (emergency, intensive care units, infectious diseases, pneumology, geriatrics …).Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001678-31-FR
- Lead Sponsor
- Assistance Publique Hopitaux de Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1120
-Individual (Male and female) aged 18 or over.
-Healthcare Worker (medical or non-medical) from hospitals in direct -contact with COVID-19 patients.
-Participants must give their written consent before any trial procedure.
-Participants covered by social security regimen (excepting AME).
-Healthy according to the opinion of the investigator.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Has any BCG vaccine contraindication, known allergy to the BCG vaccine or SAE to prior BCG vaccination.
-History of tuberculosis
-People with acquired or innate immunodeficiency.
-People have already been infected with SARS Cov-2 (virological documentation or TDM or seropositive if serology available).
-People who could not commit to follow-up for 6 months.
-People not in good general condition, as assessed by the investigator.
-People included in other therapeutic clinical trials assessing treatment
-Pregnant or breastfeeding at enrolment visit.
-BCG vaccine given within the last year.
-Another live vaccine administered in the month prior to randomization.
-History of anaphylaxis following vaccination.
-Receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year. These therapies include systemic corticosteroids (more than or equal to 10 mg for more than or equal to 2 weeks), immunosuppressant, biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).
-Another vaccine administered in the month prior to inclusion and randomization.
- Fever > 38°C within the past 24 hours
- People under legal protection measure (tutorship)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate among health care workers exposed to SARS CoV2 protection mediated by BCG against documented COVID-19.;Secondary Objective: - To evaluate protection mediated by BCG revaccination against :<br>a.Severe forms of COVID-19<br>b.Asymptomatic forms of SARS CoV2 infection<br>c.Respiratory infections<br>d.Absenteeism. <br>- To evaluate safety of BCG revaccination among health care workers.<br>- To evaluate the impact of COVID-19 on innate immunity in the context of BCG revaccination versus controls.<br>;Primary end point(s): Documented COVID-19, i.e. <br>- symptomatic COVID-19 confirmed by either positive nasopharyngeal tests for SARS CoV2 and/or by thoracic tomodensitometry compatible with the diagnosis. <br>- and/or SARS CoV2 seroconversion during the study period of 6 months. <br>;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -participants having developed a severe form of COVID-19, as defined by the necessity for hospitalization in ICU and O2 or artificial ventilation, or extracorporeal membrane oxygenation, or death; <br>-Participants with seroconversion during the study, without symptoms related to COVID-19<br>-participants presenting any kind of respiratory infection due to any cause; <br>-local and general events following BCG revaccination up to 30 days after BCG revaccination<br>-Numbers of sick days and number of sick leaves<br>-Identify and measure potentially modified markers of innate immunity upon SARS CoV2 infection by comparing BCG vaccinated and non-vaccinated controls.<br>;Timepoint(s) of evaluation of this end point: 6 months