drugset / Trial / NCT04414267
Bacillus Calmette-guérin Vaccination to Prevent COVID-19
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied
Timeline
- Start
- 2020-05-26
- Primary completion
- 2021-04-28
- Completion
- 2021-05-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCG vaccine | Vaccine | 0.1 ml | Other |