6/27/23, 11:46 PM BRACE Pathway Feedback Search Clinical Topics Home Studies BRACE BRACE Disease COVID 19 infection Trial question What is the role of the BCG vaccine in healthcare workers? Study design Multi-center Double blinded RCT Population Characteristics of study participants 75.0% female N = 3386 25.0% male 3386 patients (2526 female, 860 male) Inclusion criteria: healthcare workers Key exclusion criteria: previous positive SARS-CoV-2 test; contraindication to BCG vaccine; receipt of BCG vaccine within the past year; any other live-attenuated vaccine within the past month Interventions N=1703 BCG vaccine (receipt of BCG-Denmark vaccine with a follow-up for 12 months) N=1683 placebo (receipt of matching placebo with a follow-up for 12 months) Primary outcome Rate of symptomatic coronavirus disease 2019 by 6 months 14.7 % 14.7 12.3 11.0 % https://web.pathway.md/studies/rechMV4WEHzjC7knQ 1/2 6/27/23, 11:46 PM BRACE Pathway 7.3 % 3.7 % No significant difference 0.0 % BCG vaccine Placebo No significant difference in the rate of symptomatic COVID-19 by 6 months (14.7% vs. 12.3%; AD 2.4%, 95% CI -0.7 to 5.5) Secondary outcomes No significant difference in the rate of risk of severe COVID-19 by 6 months (7.6% vs. 6.5%; AD 1.1%, 95% CI -1.2 to 3.5) No significant difference in symptomatic or severe COVID-19 (7.9% vs. 6.4%; HR 1.23, 95% CI 0.96 to 1.59) No significant difference in pneumonia due to COVID-19 (0.4% vs. 0.4%; HR 0.93, 95% CI 0.32 to 2.64) Safety outcomes No significant difference in serious adverse events. Conclusion In healthcare workers, BCG vaccine was not superior to placebo with respect to the rate of symptomatic COVID-19 by 6 months. Reference Laure F Pittet, Nicole L Messina, Francesca Orsini et al. Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers. N Engl J Med. 2023 Apr 27;388(17):1582- 1596. Open reference URL https://web.pathway.md/studies/rechMV4WEHzjC7knQ 2/2