Table 1.
Baseline characteristics
| Characteristic | MAS825 (10 mg/kg) + SoC (n = 68) |
Placebo + SoC (n = 70) |
Total (N = 138) |
|---|---|---|---|
| Age (years) | 65.3 ± 12.54 | 63.8 ± 12.97 | 64.6 ± 12.74 |
| BMI (kg/m2) | 31.2 ± 6.53 | 30.8 ± 6.53 | 31.0 ± 6.51 |
| Male, n (%) | 38 (55.9) | 47 (67.1) | 85 (61.6) |
| Days from symptom onset to randomization | 9.5 ± 4.84 | 10.3 ± 4.69 | 9.9 ± 4.76 |
| Days from diagnosis to randomization | 3.6 ± 3.25 | 3.5 ± 3.21 | 3.6 ± 3.22 |
| Days from hospital admission to randomization | 3.4 ± 4.97 | 2.5 ± 2.74 | 3.0 ± 4.01 |
| Presence of comorbidities, n (%) | |||
| Any comorbidities | 59 (86.8) | 63 (90.0) | 122 (88.4) |
| Cerebrovascular disorder | 2 (2.9) | 4 (5.7) | 6 (4.3) |
| Cardiac disorder | 11 (16.2) | 8 (11.4) | 19 (13.8) |
| Hypertension | 51 (75.0) | 58 (82.9) | 109 (79.0) |
| Chronic kidney disease | 6 (8.8) | 6 (8.6) | 12 (8.7) |
| Neoplasm malignant | 5 (7.4) | 5 (7.1) | 10 (7.2) |
| Diabetes | 27 (39.7) | 37 (52.9) | 64 (46.4) |
| Chronic lung disease | 12 (17.6) | 10 (14.3) | 22 (15.9) |
| APACHE II scores (mean ± SD) | 11.2 ± 3.06 | 11.5 ± 3.79 | 11.4 ± 3.44 |
| Leucocyte level (109/L) | 9.8 ± 4.51 | 9.5 ± 4.44 | 9.7 ± 4.47 |
| CRP (mg/L) | 118.8 ± 80.36 | 143.4 ± 137.81 | 131.1 ± 113.06 |
| Ferritin (μg/L) | 1134.6 ± 945.10 | 1069.2 ± 918.88 | 1101.7 ± 929.13 |
| Oxygen support, n (%) | |||
| Any baseline oxygen support | 68 (100.0) | 69 (98.6) | 137 (99.3) |
| Low-flow nasal oxygen | 10 (14.7) | 16 (22.9) | 26 (18.8) |
| Oxygen via face mask | 2 (2.9) | 4 (5.7) | 6 (4.3) |
| High-flow nasal oxygen | 37 (54.4) | 34 (48.6) | 71 (51.4) |
| Non-invasive ventilation | 18 (26.5) | 15 (21.4) | 33 (23.9) |
| Mechanical ventilation | 1 (1.5) | 0 | 1 (0.7) |
| Clinical status (9-point ordinal scale), n (%) | |||
| Hospitalized: no oxygen | 0 | 1 (1.4) | 1 (0.7) |
| Hospitalized: oxygen mask/nasal prongs | 12 (17.6) | 19 (27.1) | 31 (22.5) |
| Hospitalized: non-invasive ventilation/high-flow oxygen | 56 (82.4) | 50 (71.4) | 106 (76.8) |
| Use of corticosteroids at randomization, n (%) | |||
| Any corticosteroids | 61 (89.7) | 59 (84.3) | 120 (87.0) |
| ≥20 mg | 61 (89.7) | 59 (84.3) | 120 (87.0) |
| Anti-viral treatment (prior therapy) at randomization, n (%) | 49 (72.1) | 54 (77.1) | 103 (74.6) |
| Anti-coagulant treatment (prior therapy) at randomization, n (%) | 60 (88.2) | 60 (85.7) | 120 (87.0) |
| Anti-infective treatment (prior therapy) at randomization, n (%) | 26 (38.2) | 33 (47.1) | 59 (42.8) |
Data are presented as mean ± SD unless specified otherwise.
Abbreviations: APACHE: Acute Physiology and Chronic Health Evaluation II; BMI: body mass index; CRP: C-reactive protein; SoC: standard of care.