Table 1 Patient characteristics at screening
Parameter | AP301 (n = 20) | Placebo (n = 20) |
|---|---|---|
Age, years | 47.6 ± 17.4 | 50.2 ± 14.9 |
Gender, male/female | 14 (70)/6 (30) | 12 (60)/8 (40) |
BMI, kg/m2 | 26.1 ± 3.7 | 28.5 ± 5.2 |
SOFA score | 12.5 ± 3.6 | 11.7 ± 3.4 |
Surgical | 15 (75) | 15 (75) |
Medical | 5 (25) | 5 (75) |
GOCA | ||
Gas exchange | ||
PaO2/FiO2 ratio* | ||
201–300 mmHg (mild) | 2 (10) | 3 (15) |
101–200 mmHg (moderate) | 14 (70) | 11 (55) |
≤ 100 mmHg (severe) | 4 (20) | 6 (30) |
PEEP | ||
0–5 cmH2O | 0 (0) | 0 (0) |
6–10 cmH2O | 9 (45) | 11 (55) |
>10 cmH2O | 11 (55) | 9 (45) |
Organ failure | ||
Lung only | 11 (55) | 10 (50) |
Lung + 1 organ | 4 (20) | 7 (35) |
Lung + 2 organs | 4 (20) | 3 (15) |
Lung + 3 organs | 1 (5) | 0 (0) |
Cause | ||
Direct | 12 (60) | 12 (60) |
Indirect | 8 (40) | 8 (40) |
Associated diseases | ||
No coexisting diseases | 12 (60) | 16 (80) |
Coexisting diseases causing death within 5 years | 6 (30) | 4 (20) |
Coexisting diseases causing death within 6 months | 2 (10) | 0 (0) |