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BCG Vaccination for COVID-19 Prevention in Healthcare Workers
NCT04384549Phase 3
Key facts
- Status
- Unknown
- Start
- May 2020
- Primary completion
- Feb 2021
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- bcg vaccine
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial in coronavirus disease 2019 (COVID-19) comparing BCG Arm with PLACEBO Arm (2 arms). Primary endpoint: Incidence of documented COVID-19 among health care workers at 6 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
BCG Arm
Participants receive a single dose of BCG vaccine.
PLACEBO Arm
Participants receive a single dose of placebo (saline).
03
Who it enrols
Adult healthcare workers in direct contact with COVID-19 patients, without history of TB, HIV, or recent BCG vaccination.
04
Endpoints
Primary
Incidence of documented COVID-19 among health care workers
Secondary
Numbers of COVID-19 patients requiring hospitalization in ICU and O2, artificial ventilation or extracorporal membrane oxygenation, or deaths
Incidence of asymptomatic SARS CoV2 seropositive subjects
Incidence of subjects with any respiratory infection
Numbers of sick days and numbers of sick leaves
Numbers of subjects with BCG-related adverse events
Numbers and intensity of changes in innate immune markers
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