COVID 19 Health 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 …).
Conditions
Interventions
Trade Name: VACCIN BCG AJVaccines
Product Name: VACCIN BCG AJVaccines
Pharmaceutical Form: Powder and solvent for dispersion for injection
Other descriptive name: BCG VACCINE, FREEZE-DRIED
Concentrati
Sponsors
Assistance Publique Hopitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 : a.Severe forms of COVID-19 b.Asymptomatic forms of SARS CoV2 infection c.Respiratory infections d.Absenteeism. - To evaluate safety of BCG revaccination among health care workers. - To evaluate the impact of COVID-19 on innate immunity in the context of BCG revaccination versus controls. ;Primary end point(s): Documented COVID-19, i.e. - symptomatic COVID-19 confirmed by either positive nasopharyngeal tests for SARS CoV2 and/or by thoracic tomodensitometry compatible with the diagnosis. - and/or SARS CoV2 seroconversion during the study period of 6 months. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; -Participants with seroconversion during the study, without symptoms related to COVID-19 -participants presenting any kind of respiratory infection due to any cause; -local and general events following BCG revaccination up to 30 days after BCG revaccination -Numbers of sick days and number of sick leaves -Identify and measure potentially modified markers of innate immunity upon SARS CoV2 infection by comparing BCG vaccinated and non-vaccinated controls. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
France
Contacts
Public Contactmoufida.dabbech@aphp.fr
Assistance Publique Hopitaux de Paris
Outcome results
None listed