Table 2– Efficacy and safety end-points
PrednisoneControlRelative risk (95% CI)p-value
Primary efficacy end-point
 ICU mortality17/111 (15.3)15/106 (14.2)1.08 (0.6–2.05)0.81
  ICU mortality in patients ventilated with NIV8/76 (10.5)8/71 (11.3)0.93 (0.37–2.35)0.88
  ICU mortality in patients ventilated conventionally9/35 (25.7)7/35 (20.0)1.28 (0.54–3)0.57
Secondary end-points
 NIV failure12/76 (15.7)9/71 (12.7)1.25 (0.56–2.8)0.59
 Mechanical ventilation duration days6 (4–12)6 (3.8–12)0.87
 ICU length of stay days9 (6–14)8 (6–14)0.88
Safety end-point
 Hyperglycaemic episodes requiring initiation or alteration of insulin therapy55/111 (49.5)35/106 (33.0)1.5 (1.08–2.08)0.015
  • Data are presented as n/N (%) or median (interquartile range), unless otherwise stated. ICU: intensive care unit, NIV: noninvasive ventilation.