TABLE 2.
Primary and secondary outcomes and adverse events
| All patients | Low-dose dexamethasone | High-dose dexamethasone | Risk ratio (95% CI) # | p-value | |
| Patients | 200 | 102 | 98 | ||
| Primary outcome | |||||
| Clinical worsening within 11 days | 48 (24.0) | 32 (31.4) | 16 (16.3) | 0.427 (0.216–0.842) | 0.014 |
| First event | |||||
| Worsening of the patient's condition | 47 (23.5) | 31 (30.4) | 16 (16.3) | ||
| NIV/HFNC (level 5 on the seven-level ordinal scale) | 7 (3.5) | 3 (2.9) | 4 (4.1) | ||
| Mechanical ventilation (level 6 on the seven-level ordinal scale) | 15 (7) | 6 (5.9) | 9 (9.2) | ||
| Death (level 7 on the seven-level ordinal scale) | 1 (0.5) | 1 (1.0) | 0 (0) | ||
| Secondary outcomes | |||||
| Recovery | |||||
| Day 5 | 36 (18.0) | 16 (15.7) | 20 (20.4) | 1.350 (0.648–2.816) | 0.423 |
| Day 11 | 135 (67.5) | 67 (65.7) | 68 (69.3) | 1.164 (0.625–2.170) | 0.632 |
| Day 14 | 156 (78.0) | 79 (77.5) | 77 (78.6) | 1.043 (0.504–2.162) | 0.909 |
| Day 28 | 181 (90.5) | 92 (90.2) | 89 (90.8) | 1.000 (0.369–2.711) | 1.000 |
| Time to recovery days | 7.0 (5.0–11.0) | 7.0 (5.0–11.0) | 7.0 (5.0–11.2) | 0.997 (0.961–1.035) | 0.895 |
| Admission to ICU | 28 (14.0) | 13 (12.7) | 15 (15.3) | 0.995 (0.976–1.015) | 0.622 |
| Length of ICU stay days | 8.0 (6.0–14.7) | 9.0 (6.5–15.0) | 7.0 (6.0–13.0) | 1.020 (0.952–1.093) | 0.577 |
| Mechanical ventilation requirement | 19 (9.5) | 9 (8.8) | 10 (10.2) | 0.995 (0.976–1.015) | 0.629 |
| Duration of mechanical ventilation days | 9.0 (6.0–15.0) | 13.0 (8.0–15.0) | 8.0 (4.7–12.2) | 0.997 (0.915–1.086) | 0.945 |
| Discharged from hospital within 28 days | 175 (87.5) | 90 (88.2) | 85 (86.7) | 1.021 (0.845–1.233) | 0.831 |
| Length of hospital stay days | 9.0 (6.0–14.0) | 8.5 (6.0–13.2) | 9.0 (6.7–14.0) | 0.993 (0.973–1.014) | 0.523 |
| In-hospital mortality | 10 (5) | 6 (5.9) | 4 (4.1) | 0.997 (0.977–1.017) | 0.734 |
| Complications and adverse events | |||||
| Nosocomial infection | 20 (10.0) | 10 (9.8) | 10 (10.2) | 1.081 (0.425–2.750) | 0.870 |
| Pneumonia | 12 (6.0) | 7 (6.9) | 5 (5.1) | ||
| Catheter-related bloodstream infection | 1 (0.5) | 1 (0.9) | 0 (0.0) | ||
| Bacteraemia | 5 (2.5) | 4 (3.9) | 1 (1.0) | ||
| Urinary tract infection | 6 (3.0) | 1 (0.9) | 5 (5.1) | ||
| Insulin use for hyperglycaemia | 96 (48.0) | 49 (48.0) | 47 (48.0) | 0.997 (0.572–1.736) | 0.991 |
| Thrombosis | 7 (3.5) | 6 (5.9) | 1 (1.0) | 0.169 (0.020–1.434) | 0.103 |
| Death at day 28 | 12 (6.0) | 6 (5.9) | 6 (6.1) | 1.129 (0.338–3.772) | 0.844 |
| Death at day 60¶ | 15 (8.2) | 8 (8.3) | 7 (8.0) | 1.012 (0.333–3.080) | 0.983 |
Data are presented as n, n (%) or median (interquartile range), unless otherwise stated. NIV: noninvasive ventilation; HFNC: high-flow nasal cannula; ICU: intensive care unit. #: rate ratios have been adjusted for age with respect to the outcomes studied; ¶: follow-up at 60 days was completed in 184 (92.0%) patients. Data regarding death at day 60 were missing for 10 in the low-dose dexamethasone group and six patients in the high-dose dexamethasone group.