RESULTS
death
ASYMPTOMATIC COVID-19, RECRUITMENT
A total of 3988 participants were randomised; recruitment ceased prior to reaching the planned sample size due to the availability of COVID-19 vaccines. The estimated risk of symptomatic COVID-19 by 6 months was higher in the BCG group (14.7%) compared with the placebo group (12.3%; risk difference +2.4%; 95% confidence interval [CI] −0.7% to +5.5%; p=0.13). The risk of severe COVID-19 by 6 months (comprising mainly those reporting unable to work for ≥3 days) was also higher in the BCG group (7.6%) compared with the placebo group (6.5%; risk difference +1.1%; 95% CI −1.2% to +3.5%; p=0.34). In supplementary and sensitivity analyses using less conservative censoring rules, the risk differences were similar but the confidence intervals narrower. There were 5 hospitalisations due to COVID-19 in each group (including 1 death in the placebo group). The risk of any COVID-19 episode was greater in the BCG group (hazard ratio 1.23; 95% CI 0.96 to 1.59). No safety concerns were identified.