Table 4.
Comparison of patient baseline characteristics of analysis set for secondary objective at study Day 1
| Tocilizumab (COVIREGI-JP) | SOC (COVIREGI-JP) | S.D. | |||
|---|---|---|---|---|---|
| (N = 116.00) | (N = 116.00) | ||||
| Smoking history | Current | 10.00 (8.6%) | 11.67 (10.1%) | 0.0 | |
| Former | 37.00 (31.9%) | 43.33 (37.4%) | –0.1 | ||
| Never | 47.00 (40.5%) | 38.75 (33.4%) | 0.1 | ||
| Unknown | 22.00 (19.0%) | 21.42 (18.5%) | 0.0 | ||
| Ordinal scale for clinical status | 1 | 0.00 (0.0%) | 0.00 (0.0%) | 0.0 | |
| 2 | 24.00 (20.7%) | 24.00 (20.7%) | 0.0 | ||
| 3 | 59.00 (50.9%) | 59.00 (50.9%) | 0.0 | ||
| 4 | 2.00 (1.7%) | 2.00 (1.7%) | 0.0 | ||
| 5 | 31.00 (26.7%) | 31.00 (26.7%) | 0.0 | ||
| 6 | 0.00 (0.0%) | 0.00 (0.0%) | 0.0 | ||
| 7 | 0.00 (0.0%) | 0.00 (0.0%) | 0.0 | ||
| Mechanical ventilation | Yes | 31.00 (26.7%) | 31.00 (26.7%) | 0.0 | |
| No | 85.00 (73.3%) | 85.00 (73.3%) | 0.0 | ||
| Concomitant therapy on study Day 1 | Steroid use | Yes | 88.00 (75.9%) | 81.92 (70.6%) | 0.1 |
| No | 28.00 (24.1%) | 34.08 (29.4%) | –0.1 | ||
| Favipiravir use | Yes | 53.00 (45.7%) | 33.25 (28.7%) | 0.4 | |
| No | 63.00 (54.3%) | 82.75 (71.3%) | –0.4 | ||
| Remdesivir use | Yes | 64.00 (55.2%) | 64.00 (55.2%) | 0.0 | |
| No | 52.00 (44.8%) | 52.00 (44.8%) | 0.0 | ||
| Plasmapheresis/plasma exchange | Yes | 0.00 (0.0%) | 0.00 (0.0%) | 0.0 | |
| No | 64.00 (55.2%) | 57.83 (49.9%) | 0.1 | ||
| Concomitant therapy on or after hospitalization Day 1 up to study Day 1 | Steroid Use | Yes | 88.00 (75.9%) | 84.67 (73.0%) | 0.1 |
| No | 28.00 (24.1%) | 31.33 (27.0%) | –0.1 | ||
| Favipiravir use | Yes | 61.00 (52.6%) | 38.75 (33.4%) | 0.4 | |
| No | 55.00 (47.4%) | 77.25 (66.6%) | –0.4 | ||
| Remdesivir use | Yes | 72.00 (62.1%) | 67.50 (58.2%) | 0.1 | |
| No | 44.00 (37.9%) | 48.50 (41.8%) | –0.1 | ||
| Plasmapheresis / plasma exchange | Yes | 0.00 (0.0%) | 0.00 (0.0%) | 0.0 | |
| No | 116.00 (100.0%) | 116.00 (100.0%) | 0.0 | ||
| Days from COVID-19 diagnosis | Mean (SD) | 4.7 (4.0) | 4.0 (3.8) | 0.2 | |
| Days from COVID-19 first hospitalization | Mean (SD) | 3.4 (3.4) | 3.4 (3.4) | 0.0 | |
SOC: Standard treatment for patients with severe COVID-19; S.D.: standardized difference; SD: standard deviation.
Weighted analyses were performed as appropriate to the matching ratio, and numbers of participants for weighted analyses are expressed to two decimal places