Table 2.
Comparison of patient baseline characteristics of analysis set for primary objective on study Day 1
| Tocilizumab (JA42434) | SOC (COVIREGI-JP) | S.D. | |||
|---|---|---|---|---|---|
| (N = 31.00) | (N = 31.00) | ||||
| Smoking history | Current | 6.00 (19.4%) | 1.83 (5.9%) | 0.4 | |
| Former | 12.00 (38.7%) | 15.42 (49.7%) | –0.2 | ||
| Never | 13.00 (41.9%) | 9.25 (29.8%) | 0.3 | ||
| Unknown | 0.00 (0.0%) | 4.50 (14.5%) | –0.6 | ||
| Ordinal scale for clinical status | 1 | 0.00 (0.0%) | 0.00 (0.0%) | 0.0 | |
| 2 | 3.00 (9.7%) | 3.00 (9.7%) | 0.0 | ||
| 3 | 22.00 (71.0%) | 22.00 (71.0%) | 0.0 | ||
| 4 | 2.00 (6.5%) | 2.00 (6.5%) | 0.0 | ||
| 5 | 4.00 (12.9%) | 4.00 (12.9%) | 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 | 4.00 (12.9%) | 4.00 (12.9%) | 0.0 | |
| No | 27.00 (87.1%) | 27.00 (87.1%) | 0.0 | ||
| Concomitant therapy on study Day 1 | Steroid use | Yes | 19.00 (61.3%) | 22.67 (73.1%) | –0.3 |
| No | 12.00 (38.7%) | 8.33 (26.9%) | 0.3 | ||
| Favipiravir use | Yes | 9.00 (29.0%) | 11.83 (38.2%) | –0.2 | |
| No | 22.00 (71.0%) | 19.17 (61.8%) | 0.2 | ||
| Remdesivir use | Yes | 10.00 (32.3%) | 10.00 (32.3%) | 0.0 | |
| No | 21.00 (67.7%) | 21.00 (67.7%) | 0.0 | ||
| Plasmapheresis/plasma exchange | Yes | 2.00 (6.5%) | 0.00 (0.0%) | 0.4 | |
| No | 29.00 (93.5%) | 9.25 (29.8%) | 1.7 | ||
| Concomitant therapy on or after hospitalization Day 1 up to study Day 1 | Steroid use | Yes | 22.00 (71.0%) | 23.67 (76.3%) | –0.1 |
| No | 9.00 (29.0%) | 7.33 (23.7%) | 0.1 | ||
| Favipiravir use | Yes | 9.00 (29.0%) | 13.33 (43.0%) | –0.3 | |
| No | 22.00 (71.0%) | 17.67 (57.0%) | 0.3 | ||
| Remdesivir use | Yes | 15.00 (48.4%) | 12.00 (38.7%) | 0.2 | |
| No | 16.00 (51.6%) | 19.00 (61.3%) | -0.2 | ||
| Plasmapheresis/plasma exchange | Yes | 2.00 (6.5%) | 0.00 (0.0%) | 0.4 | |
| No | 29.00 (93.5%) | 31.00 (100.0%) | –0.4 | ||
| Days from COVID-19 diagnosis | Mean (SD) | 3.8 (2.0) | 4.6 (2.7) | –0.4 | |
| Days from COVID-19 first hospitalization | Mean (SD) | 4.5 (2.5) | 4.5 (2.5) | 0.0 | |
SOC Standard treatment for patients with severe COVID-19, S.D. Standardized difference, SD Standard deviation
Weighted analysis was performed as appropriate to the matching ratio, and for weighted analyses, numbers of subjects are expressed to two decimal places