Bacillus calmette-guérin vaccination to prevent serious respiratory tract infection and covid-19 in vulnerable elderly - an adaptive randomized controlled trial (bcg-prime)

Project description There are indications that the vaccine against tuberculosis (the BCG vaccine) reduces the risk of developing respiratory infections by temporarily boosting the immune system. Elderly and chronically ill patients have an increased risk of a serious coronavirus infection. Research and expected outcomes The BCG-PRIME study is investigating the extent to which the BCG vaccine protects vulnerable elderly patients against a coronavirus infection or a clinically relevant respiratory tract infection by another pathogen. Participants are 60 years of age or older and are receiving treatment in hospital or at the thrombosis service. They are assigned BCG or a placebo by drawing lots. After that, they keep a diary about respiratory complaints for six months using a smartphone app, or they pass this information on by telephone. The study is being carried out in 22 hospitals in the Netherlands, including the seven teaching hospitals and the seven top clinical hospitals united in Santeon, and is coordinated by UMC Utrecht.