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Table 2 Distribution of baseline characteristics of patients collected at registration by treatment administration

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