Clinical outcomes in the intention-to-treat population
| Placebo + standard | Methylprednisolone pulses + standard | Hazard ratio (95% CI) | p-value | |
| Primary end-point | ||||
| Discharge without oxygen# | 111/150 (75.2) | 112/151 (75.4) | 0.92 (0.71–1.20) | 0.528 |
| Time to discharge within 30 days | 16 (13.8–18.2) | 15 (13.0–17.0) | ||
| Secondary end-points | ||||
| Admission to ICU or death¶ | 24/150 (16.1) | 30/151 (20.0) | 1.26 (0.74–2.16) | 0.176 |
| Deaths | 18/150 (12.2) | 15/151 (10.0) | 0.83 (0.42–1.64) | 0.584 |
| Explorative end-points | ||||
| Clinical worsening or death+ | 31/77 (40.3) | 37/81 (45.7) | 1.17 (0.73–1.89) | 0.430 |
| Use of high-flow oxygen or NIV, or death§ | 51/101 (50.6) | 55/104 (52.9) | 1.16 (0.79–1.70) | 0.430 |
Data are presented as n (% at 30 days) or median (95% confidence interval), unless otherwise stated. All proportions were cumulative probabilities estimated using the Kaplan–Meier product limit estimator and compared using the log-rank test. ICU: intensive care unit; NIV: noninvasive ventilation. #: one patient in the placebo arm and three patients in the methylprednisolone arm had been admitted to ICU, but had a full recovery and were discharged without oxygen within 30 days; ¶: eight patients in the placebo arm and seven patients in the methylprednisolone arm died after admission to ICU, while 10 patients and eight patients, respectively, died before being admitted to the ICU; +: in the 158 patients with arterial oxygen tension/inspiratory oxygen fraction ratio >200 mmHg at randomisation; §: in the 205 patients who received standard supplementary oxygen at randomisation.