Table 2.
Baseline characteristics of study patients
| Characteristic | Tocilizumab group (n = 57) | Standard of care group (n = 29) | Total (N = 86) |
|---|---|---|---|
| Male sex, n (%) | 34 (59.6) | 14 (48.3) | 48 (55.8) |
| Age (y) | |||
| Mean ± SD | 58.4 ± 14.1 | 58.8 ± 13.7 | 58.5 ± 13.9 |
| Age distribution, n (%) | |||
| 18–64 | 38 (66.7) | 18 (62.1) | 56 (65.1) |
| 65–84 | 18 (31.6) | 11 (37.9) | 29 (33.7) |
| ≥85 | 1 (1.75) | 0 (0) | 1 (1.2) |
| Body mass index (kg/m2), mean ± SD | 33.15 ± 6.4 | 32.8 ± 13.7 | 33.02 ± 6.9 |
| Illness severity by NEWS | |||
| Patients with NEWS assessed, n (%) | 51 (89.5) | 28 (96.6) | 79 (91.9) |
| NEWS, median (range) | 6 (1–12) | 6 (1–9) | |
| NEWS, mean ± SD | 5.9 ± 2.4 | 6 ± 2 | |
| IL-6 (normal range <5.9 ng/L) | |||
| Patients with IL-6 available at randomization, n (%) | 52 (91.2) | 27 (93.1) | 79 (91.8) |
| IL-6 (ng/L), mean ± SD | 73 ± 124 | 53 ± 58 | |
| IL-6 (ng/L), median (range) | 44 (3.75–775) | 34 (3.75–206) | |
| Patients with IL-6 at least 2 × ULN, n (% of tested) | 43 (82.7) | 25 (92.6) | 68 (86.1) |
| CRP at randomization (normal range <11 mg/L) | |||
| Patients with CRP available at randomization, n (%) | 57 (100) | 29 (100) | 86 (100) |
| CRP (mg/L), mean ± SD | 91 ± 55 | 87 ± 49 | |
| CRP (mg/L), median (range) | 84 (5–215) | 97 (7–190) | |
| Patients with CRP >40 mg/L, n (%) | 47 (82.5) | 22 (75.9) | 69 (80.2) |
| Ferritin (normal range in men <400 μg/L; women <150 μg/L) | |||
| Patients with ferritin available at randomization, n (%) | 57 (100) | 28 (96.5) | 85 (98.8) |
| Ferritin (μg/L), mean ± SD | 1036 ± 881 | 1067 ± 837 | |
| Ferritin (μg/L), median (range) | 829 (18–4199) | 924 (89–3652) | |
| Patients with ferritin at least 2 × ULN, n (% of tested) | 45 (78.9) | 22 (78.6) | 67 (78.8) |
| D-dimer (normal range <0.5 mg/L) | |||
| Patients with D-dimer available at randomization, n (%) | 57 (100) | 28 (96.6) | 85 (98.8) |
| D-dimer (mg/L), mean ± SD | 0.5 ± 0.4 | 0.5 ± 0.6 | |
| D-dimer (mg/L), median (range) | 0.3 (0.2–2.3) | 0.25 (0.2–2.5) | |
| Patients with D-dimer >1.5 mg/L, n (% of tested) | 2 (3.5) | 2 (7.1) | 4 (4.7) |
| Treatments at randomization, n (%) of patients | |||
| Low-flow (≤15 L/min) oxygen treatment | 38 (67) | 21 (72) | |
| High-flow (>15 L/min) oxygen treatment | 12 (21) | 4 (14) | |
| Noninvasive ventilation | 4 (7) | 0 (0) | |
| Invasive mechanical ventilation | 0 (0) | 1 (3.4) | 1 (1.2) |
| Glucocorticoid treatment at randomization | 52 (91) | 29 (100) | 81 (94) |
| Frequency of reported symptoms at time of admission, n (%) | |||
| Fever | 54 (94.7) | 24 (82.8) | 78 (90.8) |
| Cough | 38 (66.7) | 20 (69.0) | 58 (67.44) |
| Shortness of breath | 41 (71.9) | 22 (75.9) | 63 (73.2) |
| Chest pain | 12 (21.1) | 3 (10.3) | 15 (17.4) |
| Myalgia | 11 (19.3) | 10 (34.5) | 21 (24.4) |
| Headache | 14 (24.6) | 8 (27.6) | 22 (25.6) |
| Loss of smell and/or taste | 4 (7.0) | 3 (10.3) | 7 (8.1) |
| Fatigue | 44 (77.2) | 22 (75.9) | 66 (76.7) |
| Other neurological symptoms | 7 (12.3) | 3 (10.3) | 10 (11.6) |
| Diarrhoea | 15 (26.3) | 6 (20.7) | 21 (24.4) |
| Vomiting | 8 (14.0) | 6 (20.7) | 14 (16.3) |
| Time from onset of symptoms | |||
| Time from onset of symptoms (d), mean | 10.6 | 10.9 | |
| Time from onset of symptoms (d), median (range) | 10 (4–18) | 10 (4–18) | |
| Underlying conditions and comorbidities, n (%) | |||
| ≥1 diagnosis | 47 (82.5) | 24 (82.7) | 71 (82.5) |
| Obesity (body mass index ≥30 kg/m2) | 34 (60.7) | 20 (69.0) | 54 (63.5) |
| Diabetes mellitus | 15 (26.3) | 6 (20.7) | 21 (24.4) |
| Hypertension | 22 (38.6) | 10 (34.5) | 32 (37.2) |
| Atherosclerosis | 7 (12.3) | 2 (6.9) | 9 (10.7) |
| Chronic heart failure | 4 (7.0) | 1 (3.5) | 5 (5.81) |
| Asthma | 9 (15.8) | 3 (10.3) | 12 (14.0) |
| Chronic obstructive pulmonary disease | 2 (3.5) | 1 (3.5) | 3 (3.5) |
| Obstructive sleep apnoea | 9 (15.8) | 8 (27.6) | 17 (19.77) |
| Malignancy (treated or untreated) | 6 (10.5) | 4 (13.8) | 10 (11.6) |
| Patient independent on daily activities | 56 (98.2) | 28 (96.5) | 84 (97.7) |
| Preexisting do-not-resuscitate order in place | 5 (8.8) | 5 (17.2) | 10 (11.6) |
CRP, C-reactive protein; IL-6, interleukin 6; NEWS, National Early Warning Score; SD: standard deviation.