Table 2.

Results of the primary and secondary outcomes.

Outcome	Overall (n = 80)	Anakinra (n = 40)	Standard of care (n = 40)	p-value
Primary outcome
Percentage of patients with treatment success at day 14, n (%) [95% CI]	72 (90.0)	35 (87.5) [0.715–2.312]	37 (92.5) [0.290–1.835]	0.712
Secondary outcomes
Duration of mechanical ventilation in ventilated patients up to day 14, median days (IQR) [95% CI]	6.50 (2.0)	6.50 (2.0) [4.73–7.77]	NA [na]	NA
Change in WHO score from baseline to day 7, median (IQR) [95% CI]	1 (0–1)	1 (1) [0.31–0.85]	1 (1) [0.58–1.2]	0.211
Change in viral burden (CT value) from baseline to day 7, median (IQR) [95% CI]	13.1 (7.8–23.2)	6.1 (14.9) [10.2–16.0]	9.8 (7.7) [13.8–19.9]	0.09
Change in viral burden (CT value) from baseline to day 10–14, median (IQR) [95% CI]	17.6 (8.5–23.9)	15.8 (16.0) [9.7–22.1]	17.6 (17.0) [9.4–21.1]	0.923
Time to ICU admission in non-ICU patients up to 28 days, median time (IQR) [95% CI]	6.0 (4.0–15.0)	7.5 (13.0) [0.2–3.3]	6.0 (15.3) [1.3–4.3]	1.00
Length of hospital Stay, median days (IQR) [95% CI]	10.0 (8.0–13.0)	10.0 (4) [10.4–13.8]	10.0 (4) [9.3–12.0]	0.064
All-cause mortality, n (%) [95% CI]	1 (1.25)	0 (0) [na]	1 (2.5) [na]	1.000

IQR, interquartile range; CT, cycle threshold; ICU, intensive care; CI, confidence interval.