From: Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial
 | Phase 2 | Validation | ||||
---|---|---|---|---|---|---|
Treated (n = 180) | Not treated (n = 121) | P | Treated (n = 528) | Not treated (n = 360) | P | |
Geographic area—no. (%) |  |  |  < 0.001 |  |  | 0.30 |
 Lombardia | 94 (52.2%) | 42 (34.7%) |  | 195 (36.9%) | 140 (38.9%) |  |
 Veneto | 14 (7.8%) | 51 (42.1%) |  | 28 (5.3%) | 12 (3.3%) |  |
 Emilia Romagna | 29 (16.1%) | 8 (6.6%) |  | 76 (14.4%) | 65 (18.1%) |  |
 Other Northern regions | – | – |  | 51 (9.7%) | 40 (11.1%) |  |
 Center | 23 (12.8%) | 16 (13.2%) |  | 107 (20.3%) | 61 (16.9%) |  |
 South and Islands | 20 (11.1%) | 4 (3.3%) |  | 71 (13.4%) | 42 (11.7%) |  |
Age—no. (%) |  |  | 0.04 |  |  | 0.22 |
  ≤ 60 | 79 (43.9%) | 43 (35.5%) |  | 209 (39.6%) | 156 (43.3%) |  |
 61–70 | 67 (37.2%) | 40 (33.1%) |  | 148 (28.0%) | 107 (29.7%) |  |
 71 +  | 34 (18.9%) | 38 (31.4%) |  | 171 (32.4%) | 97 (26.9%) |  |
Female sex—no. (%) | 31 (17.2%) | 28 (23.1%) | 0.20 | 108 (20.5%) | 85 (23.6%) | 0.26 |
Ethnic group—no. (%) |  |  | 0.42 |  |  | 0.1 |
 Caucasian | 170 (97.1%) | 101 (97.1%) |  | 494 (97.4%) | 333 (97.9%) |  |
 Asiatic | 1 (0.6%) | 2 (1.9%) |  | 2 (0.4%) | 0 (0.0%) |  |
 Other | 4 (2.3%) | 1 (1.0%) |  | 11 (2.2%) | 7 (2.1%) |  |
 Unknown | 5 | 17 |  | 21 | 20 |  |
Body Mass Index—no. (%) |  |  | 0.06 |  |  | 0.74 |
 Underweight/normal | 40 (24.7%) | 35 (35.7%) |  | 112 (27.1%) | 73 (26.0%) |  |
 Overweight/Obese | 122 (75.3%) | 63 (64.3%) |  | 301 (72.9%) | 208 (74.0%) |  |
 Unknown | 18 | 23 |  | 115 | 79 |  |
Previous/actual smoker—no. (%) | 33 (22.4%) | 18 (21.7%) | 0.89 | 130 (30.2%) | 79 (27.9%) | 0.52 |
 Unknown | 33 | 38 |  | 97 | 77 |  |
Antiflu 2019 vaccination—no. (%) | 31 (21.5%) | 23 (31.9%) | 0.10 | 75 (21.8%) | 44 (18.5%) | 0.33 |
 Unknown | 36 | 49 |  | 184 | 122 |  |
Initial respiratory support– no. (%) |  |  | 0.003 |  |  | < 0.001 |
 Oxygen supplement | 73 (40.6%) | 73 (60.3%) |  | 223 (42.2%) | 223 (61.9%) |  |
 NIMV | 74 (41.1%) | 32 (26.4%) |  | 238 (45.1%) | 112 (31.1%) |  |
 IMV | 33 (18.3%) | 16 (13.2%) |  | 67 (12.7%) | 25 (6.9%) |  |
PaO2/FiO2 ratio– no. (%) |  |  | 0.08 |  |  | < 0.001 |
  ≤ 100 | 36 (33.6%) | 19 (30.2%) |  | 91 (25.9%) | 30 (18.3%) |  |
 101–200 | 53 (49.5%) | 23 (36.5%) |  | 170 (48.4%) | 66 (40.2%) |  |
 201–300 | 14 (13.1%) | 18 (28.6%) |  | 68 (19.4%) | 44 (26.8%) |  |
 > 300 | 4 (3.7%) | 3 (4.8%) |  | 22 (6.3%) | 24 (14.6%) |  |
 Unknown | 73 | 58 |  | 177 | 196 |  |
Heart disease—no. (%) | 31 (17.8%) | 31 (27.4%) | 0.053 | 99 (19.4%) | 48 (15.6%) | 0.17 |
 Unknown | 6 | 8 |  | 18 | 53 |  |
Hypertension—no. (%) | 92 (52.9%) | 55 (48.7%) | 0.49 | 242 (47.5%) | 141 (45.9%) | 0.67 |
 Unknown | 6 | 8 |  | 18 | 53 |  |
Diabetes—no. (%) | 23 (13.2%) | 11 (9.7%) | 0.37 | 84 (16.5%) | 51 (16.6%) | 0.96 |
 Unknown | 6 | 8 |  | 18 | 53 |  |
Anti-retroviral—no. (%) | 112 (65.1%) | 113 (60.2%) | 0.40 | 342 (66.4%) | 224 (69.4%) | 0.38 |
 Unknown | 8 | 8 |  | 13 | 37 |  |
Hydroxy-chloroquine—no. (%) | 130 (75.6%) | 77 (68.1%) | 0.17 | 395 (76.7%) | 244 (75.5%) | 0.70 |
 Unknown | 8 | 8 |  | 13 | 37 |  |
Antibiotics—no. (%) | 84 (48.8%) | 34 (30.1%) | 0.002 | 274 (53.2%) | 163 (50.5%) | 0.44 |
 Unknown | 8 | 8 |  | 13 | 37 |  |
Steroids—no. (%) | 41 (23.9%) | 21 (18.6) | 0.29 | 176 (34.2%) | 115 (35.6%) | 0.67 |
 Unknown | 8 | 8 |  | 13 | 37 |  |
LMW heparin—no. (%) | 45 | 221 | 0.14 | 116 (22.5%) | 57 (17.7%) | 0.09 |
 Unknown | 8 | 8 |  | 13 | 37 |  |
C-reactive protein—median (IQR) | 30 (13–116) | 73 (17–122) | 0.06 | 31 (14–132) | 57 (14–144) | 0.38 |
 Unknown | 34 | 29 |  | 102 | 128 |  |