COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04384549

Odile LAUNAY, Professor

odile.launay@aphp.fr

2020-05-12

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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.

- 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)

2

Assistance Publique - Hôpitaux de Paris

18

100

France

Health workers

N/A

1120

Incidence of documented COVID-19 among health care workers exposed to SARS CoV2 and vaccinated with BCG compared to placebo.

None

Phase 3

[{"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]