Table 1.
Baseline characteristics.
| Baseline variable | Europe |
India |
||
|---|---|---|---|---|
| 12 mg (n = 315) | 6 mg (n = 298) | 12 mg (n = 182) | 6 mg (n = 187) | |
| Country of Inclusion | ||||
| Denmark | 251 (79.7%) | 234 (78.5%) | – | – |
| Sweden | 40 (12.7%) | 39 (13.1%) | – | – |
| Switzerland | 24 (7.6%) | 25 (8.4%) | – | – |
| India | – | – | 182 (100%) | 187 (100%) |
| Age in years–median (IQR) | 65.0 (57.0–74.5) | 66.0 (57.0–73.8) | 63.5 (54.0–70.0) | 61.0 (51.5–70.0) |
| Sex (n and %) | ||||
| Male | 214 (67.9%) | 214 (71.8%) | 132 (72.5%) | 117 (62.6%) |
| Weight in kgs–median (IQR) | 90.0 (76.0–104.5) | 90.0 (77.0–100.0) | 65.5 (60.0–73.8) | 68.0 (60.0–75.0) |
| Coexisting conditions (n and %) | ||||
| Ischemic heart disease or heart failure | 46 (14.6%) | 47 (15.8%) | 21 (11.5%) | 22 (11.8%) |
| Diabetes mellitus | 62 (19.7%) | 87 (29.2%) | 73 (40.1%) | 76 (40.6%) |
| Chronic obstructive pulmonary disease | 49 (15.6%) | 46 (15.4%) | 8 (4.4%) | 10 (5.3%) |
| Immunosuppressive therapy within 3 months prior to randomization | 27 (8.6%) | 24 (8.1%) | 13 (7.1%) | 19 (10.2%) |
| Chronic use of systemic glucocorticoids | 11 (3.5%) | 15 (5.0%) | 2 (1.1%) | 1 (0.5%) |
| Limitations in the use of CPR or life support at randomization (n and %) | 29 (9.2%) | 25 (8.4%) | 1 (0.5%) | 1 (0.5%) |
| Time from onset of symptoms to hospitalization in days–median (IQR)a | 8.0 (5.0–10.0) | 8.0 (5.0–10.0) | 5.0 (3.0–7.0) | 5.0 (3.0–7.0) |
| Time from hospitalization to randomization in days–median (IQR) | 2.0 (1.0–3.0) | 1.0 (1.0–3.0) | 2.0 (1.0–3.0) | 2.0 (1.0–3.0) |
| Place of enrollment, n and % | ||||
| Intensive care unit | 222 (70.5%) | 215 (72.1%) | 167 (91.8%) | 178 (95.2%) |
| Hospital ward | 61 (19.4%) | 53 (17.8%) | 5 (2.7%) | 1 (0.5%) |
| Emergency department | 14 (4.4%) | 13 (4.4%) | 8 (4.4%) | 8 (4.3%) |
| Intermediate care unit | 18 (5.7%) | 17 (5.7%) | 2 (1.1%) | 0 (0.0%) |
| Type of oxygen supplementation | ||||
| Nasal cannula or open mask, n and % | 190 (60.3%) | 176 (59.1%) | 82 (45.1%) | 82 (43.9%) |
| Flow rate in L/min, median (IQR) | 23.5 (15.0–37.0) | 25.0 (15.0–40.0) | 15.0 (12.0–45.0) | 16.0 (12.0–48.8) |
| Noninvasive ventilation or continuous positive airway pressure, n and % | 39 (12.4%) | 45 (15.1%) | 79 (43.4%) | 83 (44.4%) |
| Fio2 in %, median (IQR)b | 80.0 (67.5–99.0) | 70.0 (64.0–100.0) | 50.0 (50.0–60.0) | 50.0 (40.0–60.0) |
| Duration before randomization in days, median (IQR) | 1.0 (0.0–1.0) | 1.0 (0.0–1.0) | 1.0 (0.0–1.0) | 1.0 (0.0–1.5) |
| Invasive ventilation, n and % | 86 (27.3%) | 77 (25.8%) | 21 (11.5%) | 22 (11.8%) |
| Fio2 in %, median (IQR)c | 55.0 (45.0–70.0) | 60.0 (45.0–90.0) | 70.0 (60.0–90.0) | 62.5 (50.0–70.0) |
| Duration before randomization in days, median (IQR) | 1.0 (0.0–1.0) | 1.0 (0.0–1.0) | 1.0 (0.0–1.0) | 1.0 (1.0–1.0) |
| Baseline Oxygenation status | ||||
| PaO2 in mmHg (median/IQR)d | 69.8 (61.5–83.1) | 70.0 (62.2–81.0) | 76.5 (60.8–100.0) | 72.0 (58.8–83.4) |
| Saturation in % (median/IQR)e | 94.0 (91.0–96.0) | 93.0 (91.0–96.0) | 95.0 (91.0–97.0) | 94.0 (90.0–96.5) |
| Lactate concentration in mg/dl (median/IQR)f | 15.3 (11.7–23.4) | 15.8 (11.7–21.6) | 10.8 (6.3–18.0) | 13.5 (8.1–18.2) |
| Vasopressors or inotropes | 68 (21.6%) | 57 (19.1%) | 13 (7.1%) | 11 (5.9%) |
| Kidney replacement therapy | 7 (2.2%) | 7 (2.3%) | 4 (2.2%) | 7 (3.7%) |
| Anti-inflammatory agents | 31 (9.8%) | 31 (10.4%) | 27 (14.8%) | 26 (13.9%) |
| IL-6 receptor antagonists | 25 (7.9%) | 23 (7.7%) | 27 (14.8%) | 24 (12.8%) |
| Janus kinase inhibitor | 0 (0.0%) | 0 (0.0%) | 8 (4.4%) | 7 (3.7%) |
| Other | 7 (2.2%) | 8 (2.7%) | 2 (1.1%) | 2 (1.1%) |
| Antiviral agents | 162 (51.4%) | 157 (52.7%) | 150 (82.4%) | 161 (86.1%) |
| Remdesivir | 157 (49.8%) | 151 (50.7%) | 150 (82.4%) | 159 (85.0%) |
| Convalescent plasma | 4 (1.3%) | 7 (2.3%) | 7 (3.8%) | 10 (5.3%) |
| Other | 9 (2.9%) | 4 (1.3%) | 0 (0.0%) | 2 (1.1%) |
Abbreviations: CPR: Cardiopulmonary Resuscitation; Fio2: Fraction of inspired oxygen; PaO2: Partial pressure of oxygen; IL-6: Interleukin 6.
a
Proportion missing 5.1%.
b
Missing 1.2%.
c
Missing 0.1%.
d
Missing 5.2%.
e
Missing 1.4%.
f
Missing 10.8%.