Status:
UNKNOWN
Efficacy of BCG Vaccination in the Prevention of COVID19 Via the Strengthening of Innate Immunity in Health Care Workers
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Infection
Viral, Agent as Cause of Disease Classified Elsewhere
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Healthcare Workers (HCW) are at high risk for COVID-19. In addition to the risk of serious forms among HCW, significant absenteeism due to illness would have dramatic consequences in our ability to fi...
Detailed Description
Randomized, multicenter phase III controlled trial, in 2 parallel arms: * One group vaccinated with BCG * One group receiving placebo (0.9 % saline) Randomization in a 1: 1 ratio will be stratified o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 clinical trials assessing treatment.
- Pregnant or breastfeeding or positive urine pregnancy 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 with malignancies (e.g. lymphoma, leukemia, Hodgkin's disease or other tumors of the reticuloendothelial system) or infected with HIV
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Acute severe febrile illness
- Generalized infected skin conditions
- People under legal protection measure (tutorship, curatorship or safeguard measures)
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2021
Estimated Enrollment :
1120 Patients enrolled
Trial Details
Trial ID
NCT04384549
Start Date
May 20 2020
End Date
February 20 2021
Last Update
August 18 2020
Active Locations (1)
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1
I-REIVAC/CIC 1417 Cochin Hospital, APHP
Paris, France, 75014