drugset / Trial / NCT04414267

Bacillus Calmette-guérin Vaccination to Prevent COVID-19

NCT04414267

Phase 4 Completed 301 enrolled Hellenic Institute for the Study of Sepsis
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

EvaluationDrugModalityDoseRoute
Subject BCG vaccine Vaccine 0.1 ml Other