Table 2.

Primary and secondary outcomes

Endpoint	Intervention	Number of subjects	FU timea	Number of events	Cumulative incidenceb	SDHR
COVID-19	Placebo	3054	1479.4	115	0.038 (0.031–0.045)	[ref]
	BCG	3058	1480.8	129	0.042 (0.036–0.050)	1.12 (0.87–1.44)
Documented SARS-CoV-2 infection	Placebo	3054	1477.3	126	0.041 (0.035–0.049)	[ref]
	BCG	3058	1476.9	144	0.047 (0.040–0.055)	1.15 (0.90–1.45)
Asymptomatic SARS-CoV-2 infection	Placebo	3054	1508.0	11	0.004 (0.002–0.006)	[ref]
	BCG	3058	1510.7	16c	0.005 (0.003–0.008)	1.46 (0.68–3.14)
Mild-moderate SARS-CoV-2 infection	Placebo	3054	1485.1	94	0.031 (0.025–0.037)	[ref]
	BCG	3058	1485.0	111c	0.036 (0.030–0.044)	1.18 (0.90–1.55)
COVID-19-related admissions	Placebo	3054	1505.7	21	0.007 (0.004–0.010)	[ref]
	BCG	3058	1510.9	18	0.006 (0.004–0.009)	0.86 (0.46–1.61)
Clinically relevant RTI	Placebo	3054	1491.7	72d	0.024 (0.019–0.030)	[ref]
	BCG	3058	1497.4	66e	0.022 (0.017–0.027)	0.89 (0.63–1.24)
Medically attended RTI	Placebo	3054	1492.8	68	0.022 (0.018–0.028)	[ref]
	BCG	3058	1496.1	68	0.022 (0.018–0.028)	1.00 (0.72–1.41)
RTI-related hospital admission	Placebo	3054	1503.6	29	0.010 (0.007–0.014)	[ref]
	BCG	3058	1508.1	26	0.009 (0.006 - 0.012)	0.90 (0.53 - 1.53)
Clinically relevant RTI not including COVID-19	Placebo	3054	1497.4	50	0.016 (0.012–0.021)	[ref]
	BCG	3058	1503.6	38	0.012 (0.009–0.017)	0.76 (0.50–1.16)
RTI-like symptomsf	Placebo	3054	1367.0	440	0.144 (0.132–0.157)	[ref]
	BCG	3058	1364.6	465	0.152 (0.140–0.165)	1.06 (0.93–1.21)
Pneumoniag	Placebo	3054	1505.9	24	0.008 (0.005–0.012)	[ref]
	BCG	3058	1509.3	18	0.006 (0.004–0.009)	0.75 (0.41–1.39)

BCG, Bacillus Calmette-Guérin; FU, follow-up; RTI, respiratory tract infection; SDHR, sub-distribution hazard ratio; [ref], reference category.

^aFollow-up time (person-years). This includes time until the first event, occurrence of a competing event, loss to follow-up, or day 182, whichever occurred first.

^bFrom the cumulative incidence function, taking into account competing events and censoring. The value represents a proportion.

^cOne participant had two episodes, the first mild-moderate and the second asymptomatic.

^dFive participants had two episodes, one had three episodes and other one had four episodes.

^eTwo participants had two episodes and one had three episodes.

^fBased on self-reported symptoms.

^gSelf-reported, medically diagnosed, not including documented COVID-19.