TABLE 2.
Outcomes
| Primary outcome | Senicapoc group (n = 20) | Control group (n = 26) | Unadjusted analysis | Adjusted analysis |
|---|---|---|---|---|
| Senicapoc group (n = 20) | Control group (n = 26) | |||
| PaO2/FiO2 ratio (kPa) 72 h—Mean (SD) | 19.5 (6.6) | 24.4 (9.6) | Mean difference −4.9 (95% CI −9.8 to −0.0) p = .049 | Mean difference −5.1 (95% CI −10.2 to −0.0) p = .048 a |
| Secondary outcomes | ||||
| Ventilator‐free hours—Median (IQR) hours | 607 (398 to 672) | 486 (0 to 672) | p = .19 b | p = .15 c |
| 28‐day mortality—no. (%) | 2 (10) | 6 (23) | OR 0.37 (95% CI 0.07 to 2.07) p = .26 | OR 0.36 (95% CI 0.06 to 2.07) p = .26 d |
| Other outcomes | ||||
| Vasopressor‐free hours—Median (IQR) | 672 (627 to 672) | 616 (490 to 672) | p = .07 b | p = .08 c |
| Renal replacement therapy—no. (%) | 0 (0) | 5 (19.2) | p = .06 e | |
| SOFA score 72 h—Median (IQR) | 4.5 (2 to 7.5) | 7 (2 to 10) | p = .35 b | p = .32 c |
| Median health‐related quality of life (EQ‐5D‐5L) index score (IQR) f | 53 (47 to 69) | 69 (−29 to 79) | p = .48 b | p = 1.0 c |
| Median EQ VAS (IQR) f | 50 (40 to 65) | 45 (7.5 to 72.5) | p = .77 b | p = .76 c |
Abbreviations: IQR, interquartile range; SD, standard deviation; SOFA: sequential organ failure assessment.
a
Adjusted for site and baseline PaO2/FiO2 ratio.
b
Wilcoxon rank sum test.
c
Van Elteren's test stratified by baseline PaO2/FiO2 ratio <20 kPa or ≥20 kPa.
d
Due to low number of outcomes only adjusted for baseline PaO2/FiO2 ratio.
e
Fisher's exact test.
f
Including 18 patients in the senicapoc group and 20 in the control group. 1 patient in senicapoc group and 5 patients in the control group had worst values assigned.