Table 1 Baseline characteristics
Total (n = 197) | Vilobelimab (n = 96) | Placebo (n = 101) | |
|---|---|---|---|
Age (years) | |||
Mean | 61.4 (12.3) | 60.4 (12.8) | 62.3 (11.9) |
Min–max | 23–81 | 23–81 | 23–81 |
Median | 64.0 [54.0–71.0] | 64.0 [53.0–71.0] | 64.0 [55.0–71.0] |
Sex | |||
Male | 144 (73.1%) | 73 (76.0%) | 71 (70.3%) |
Female | 53 (26.9%) | 23 (24.0%) | 30 (29.7%) |
Country | |||
Belgium | 14 (7.1%) | 7 (7.3%) | 7 (6.9%) |
Germany | 21 (10.7%) | 10 (10.4%) | 11 (10.9%) |
France | 33 (16.8%) | 16 (16.7%) | 17 (16.8%) |
Netherlands | 129 (65.5%) | 63 (65.6%) | 66 (65.3%) |
Race | |||
White | 129 (65.5%) | 66 (68.8%) | 63 (62.4%) |
Asian | 9 (4.6%) | 4 (4.2%) | 5 (5.0%) |
Black or African American | 9 (4.6%) | 2 (2.1%) | 7 (6.9%) |
Other | 21 (10.7%) | 11 (11.5%) | 10 (9.9%) |
Not reported | 29 (14.7%) | 13 (13.5%) | 16 (15.8) |
BMI (kg/m2) | |||
Mean | 30.5 (5.7) | 30.8 (5.3) | 30.1 (6.1) |
Min–max | 18–55 | 22–46 | 18–55 |
Median | 29.5 [26.6–32.8] | 30.3 [27.4–32.7] | 28.8 [26.1–32.9] |
Estimated glomerular filtration rate | |||
< 60 mL/min/1.73m2 | 61 (31.0%) | 28 (29.2) | 33 (32.7) |
≥ 60 mL/min/1.73m2 | 136 (69.0%) | 68 (70.8%) | 68 (67.3%) |
Comorbidities | |||
Hypertension | 95 (48.2%) | 42 (43.8%) | 53 (52.5%) |
Diabetes | 73 (37.1%) | 32 (33.3%) | 41 (40.6%) |
Coronary heart disease | 23 (11.7%) | 11 (11.5%) | 12 (11.9%) |
Chronic obstructive pulmonary disease | 5 (2.5%) | 4 (4.2%) | 1 (1.0%) |
Carcinoma | 3 (1.5%) | 1 (1.0%) | 2 (2.0%) |
Chronic kidney disease | 19 (9.6%) | 7 (7.3%) | 12 (11.9%) |
Obesity | 62 (31.5%) | 29 (30.2%) | 33 (32.7%) |
Acute respiratory distress syndrome | |||
Mild (PaO2/FiO2 200–300 mm Hg)a | 2 (1.0%) | 1 (1.0%) | 1 (1.0%) |
Moderate (PaO2/FiO2 100–200 mm Hg) | 145 (73.6%) | 72 (75.0%) | 73 (72.3%) |
Severe (PaO2/FiO2 ≤ 100 mm Hg) | 50 (25.4%) | 23 (24.0%) | 27 (26.7%) |
8-point WHO COVID-19 ordinal scale | |||
6 (intubation and mechanical ventilation) | 47 (23.9%) | 29 (30.2%) | 18 (17.8%) |
7 (ventilation plus organ support) | 150 (76.1%) | 67 (69.8%) | 83 (82.2%) |
Time between onset of first COVID-19 symptoms and randomization (days) | |||
Mean | 10.1 (5.7) | 10.4 (5.4) | 9.9 (6.0) |
Min–max | 0–31 | 0–31 | 0–29 |
Median | 10.0 [6.0–14.0] | 11.0 [6.0–14.0] | 10.0 [5.0–14.0] |
Time between hospital admission and randomization (days) | |||
Mean | 4.3 (3.9) | 3.9 (3.0) | 4.7 (4.6) |
Min–max | 0–27 | 0–19 | 0–27 |
Median | 4.0 [2.0–5.0] | 3.5 [2.0–5.0] | 4.0 [2.0–6.0] |
Time between ICU admission and randomization (days) | |||
Mean | 2.5 (3.1) | 2.2 (1.8) | 2.9 (3.9) |
Min–max | 0–22 | 0–11 | 0–22 |
Median | 2.0 [1.0–3.0] | 2.0 [1.0–3.0] | 1.0 [1.0–3.0] |
Time between intubation onset and first IMP administration (hours) | |||
Mean | 22.2 (14.4) | 23.5 (15.1) | 20.8 (13.7) |
Min–max | 0–52 | 0–52 | 3–51 |
Median | 23.0 [11.2–37.6] | 24.2 [11.5–40.8] | 22.8 [10.6–33.6] |