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Table 1 Baseline characteristics of patients in the ITT phase 2 and validation cohorts

From: Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

 

ITT Phase 2

ITT Validation

N = 301

N = 920

Geographic area—no. (%)

 Lombardia

136 (45.2%)

346 (37.6%)

 Veneto

65 (21.6%)

41 (4.5%)

 Emilia Romagna

37 (12.3%)

142 (15.4%)

 Other Northern regions

–

91 (9.9%)

 Center

39 (13.0%)

186 (20.2%)

 South and Islands

24 (8.0%)

114 (12.4%)

Age—no. (%)

  ≤ 60

122 (40.5%)

375 (40.8%)

 61–70

107 (35.5%)

263 (28.6%)

 71 + 

72 (23.9%)

282 (30.7%)

Female sex—no. (%)

59 (19.6%)

200 (21.7%)

Ethnic group—no. (%)

 Caucasian

271 (97.1%)

853 (97.7%)

 Asiatic

3 (1.1%)

2 (0.2%)

 Other

5 (1.8%)

18 (2.1%)

 Unknown

22

47

Body mass index—no. (%)

 Underweight/normal (< 25)

75 (28.8%)

192 (26.9%)

 Overweight/obese (25 +)

185 (71.2%)

521 (73.1%)

 Unknown

41

207

Previous/actual smoker—No. (%)

51 (22.2%)

214 (29.2%)

 Unknown

71

188

Antiflu 2019 vaccination—No. (%)

54 (25.0%)

121 (20.3%)

 Unknown

85

325

Initial respiratory support—No. (%)

 Oxygen supplementation

146 (48.5%)

468 (50.9%)

 NIMV

106 (35.2%)

359 (39.0%)

 IMV

49 (16.3%)

93 (10.1%)

PaO2/FiO2 ratio—median (IQR)

136 (93,198)

154 (103,218)

PaO2/FiO2 ratio—No. (%)

  

  < 100

55 (32.4%)

129 (24.1%)

 101–200

76 (44.7%)

244 (45.5%)

 201–300

32 (18.8%)

116 (21.6%)

  > 300

7 (4.1%)

47 (8.8%)

 Missing or not tested

131

384

Comorbidities (mild or worse)—No. (%)

  

 Heart disease

62 (21.6%)

150 (18.1%)

 Hypertension

147 (51.2%)

389 (47.0%)

 Diabetes

34 (11.8%)

138 (16.7%)

 Unknown

14

93

Concurrent treatment, no. (%)

  

 Antiretroviral

180 (63.1%)

576 (67.6%)

 Hydroxy-chloroquine

207 (72.6%)

651 (76.4%)

 Antibiotics

118 (41.4%)

443 (52.0%)

 Steroids

62 (21.8%)

296 (34.7%)

 LMW heparin

66 (23.2%)

175 (20.5%)

 Unknown

16

68

C-reactive protein—median (IQR)

37.6 (14.7, 120.0)

36.3 (13.7, 137.0)

 Missing or not tested

181

255