BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial).
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Pittet Laure F, Messina Nicole L, Gardiner Kaya, Orsini Francesca, Abruzzo Veronica, Bannister Samantha, Bonten Marc, Campbell John L, Croda Julio, Dalcolmo Margareth, Elia Sonja, Germano Susie, Goodall Casey, Gwee Amanda, Jamieson Tenaya, Jardim Bruno, Kollmann Tobias R, Guimarães Lacerda Marcus Vinícius, Lee Katherine J, Legge Donna, Lucas Michaela, Lynn David J, McDonald Ellie, Manning Laurens, Munns Craig F, Perrett Kirsten P, Prat Aymerich Cristina, Richmond Peter, Shann Frank, Sudbury Eva, Villanueva Paola, Wood Nicholas J, Lieschke Katherine, Subbarao Kanta, Davidson Andrew, Curtis Nigel, BRACE trial Consortium Group
Аннотация
METHODS AND ANALYSIS: This international multicentre phase III randomised controlled trial aims to determine if BCG vaccination reduces the incidence of symptomatic and severe COVID-19 at 6 months (co-primary outcomes) compared with no BCG vaccination. We plan to randomise 10 078 HCWs from Australia, The Netherlands, Spain, the UK and Brazil in a 1:1 ratio to BCG vaccination or no BCG (control group). The participants will be followed for 1 year with questionnaires and collection of blood samples. For any episode of illness, clinical details will be collected daily, and the participant will be tested for SARS-CoV-2 infection. The secondary objectives are to determine if BCG vaccination reduces the rate, incidence, and severity of any febrile or respiratory illness (including SARS-CoV-2), as well as work absenteeism. The safety of BCG vaccination in HCWs will also be evaluated. Immunological analyses will assess changes in the immune system following vaccination, and identify factors associated with susceptibility to or protection against SARS-CoV-2 and other infections.
ETHICS AND DISSEMINATION: Ethical and governance approval will be obtained from participating sites. Results will be published in peer-reviewed open-access journals. The final cleaned and locked database will be deposited in a data sharing repository archiving system.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04327206.