TABLE 1.
Patient Characteristics
| Parameter | Placebo (n = 24) | Cohort 1 (n = 16) | Cohort 2 (n = 16) | Cohort 3 (n = 16) |
|---|---|---|---|---|
| Male sex | 16 (66.7%) | 10 (62.5%) | 9 (56.3%) | 11 (68.8%) |
| Age (yr) | 65 (53–75) | 65 (61–81) | 70 (51–83) | 78 (66–80) |
| Body mass index (kg/m2) | 25.3 (22–27) | 26.4 (24–32) | 26.6 (24–31) | 27.3 (24–30) |
| Acute Physiology And Chronic Health Evaluation-II score | 22.5 (17–27) | 19.5 (18–22) | 17.5 (14–26) | 20.0 (18–27) |
| SOFA score | 9.0 (8–11) | 8.5 (7–10) | 9.0 (7–11) | 8.5 (7–11) |
| Modified mean SOFA until day 10 with CNS subscore omitted and calculating renal subscore without considering urine output | 8.0 (7–10) | 7.0 (7–10) | 7.0 (6–8) | 7.5 (7–10) |
| Acute kidney injury | 6 (25.0%) | 2 (12.5%) | 6 (37.5%) | 6 (37.5%) |
| Vasopressor use | 22 (91.7%) | 15 (93.8%) | 13 (81.3%) | 14 (87.5%) |
| Mechanical ventilation | 20 (83.3%) | 16 (100%) | 12 (75.0%) | 10 (62.5%) |
| Surgery | 18 (75.0%) | 16 (100%) | 12 (75.0%) | 11 (68.8%) |
| Primary focus | ||||
| Pulmonary | 9 (37.5%) | 6 (37.5%) | 6 (37.5%) | 7 (43.8%) |
| Abdominal | 15 (62.5%) | 10 (62.5%) | 10 (62.5%) | 9 (56.3%) |
| Coexisting diseases | ||||
| Coronary artery disease | 5 (20.8%) | 6 (37.5%) | 1 (6.3%) | 2 (12.5%) |
| Diabetes mellitus | 2 (8.3%) | 3 (18.8%) | 1 (6.3%) | 2 (12.5%) |
| Arterial hypertension | 10 (41.7%) | 9 (56.3%) | 8 (50.0%) | 13 (81.3%) |
| Chronic obstructive pulmonary disease | 3 (12.5%) | 1 (6.3%) | 5 (31.3%) | 3 (18.8%) |
| Lactate (mmol/L) | 1.9 (1.6–3.7) | 2.6 (1.7–4.2) | 2.75 (1.6–4.4) | 3.89 (2.6–6.6) |
| Time to IP (CD only) (hr) | 4.5 (4–6) | 4.5 (3–6) | 3.3 (2–6) | 4.0 (1–5) |
| Time to IP (non-CD only) (hr) | 8.1 (5–10) | 6.2 (4–10) | 6.8 (5–9) | 6.8 (3–10) |
CD = cardiovascular dysfunction, IP = first infusion of investigational product (vilobelimab or placebo), SOFA = Sequential Organ Failure Assessment.
Data are presented as median and 25% and 75% percentiles or absolute numbers (percentage).