TABLE II.
Primary Outcomes
| Parameter | Sargramostim arm | SOC arm | P-value |
|---|---|---|---|
| P(A–a)O2, patients with both baseline and post-baseline, up-to-day 6, n | 63 | 33 | |
| Baseline P(A–a)O2, mean (SD), mmHg | 299.4 (183.5) | 326.0 (172.2) | |
| Post-baseline P(A–a)O2, up-to-day 6, mean (SD), mmHg | 199.5 (196.3) | 290.8 (212.5) | |
| Change from baseline P(A–a)O2, up-to-day 6, LS mean (SE), mmHg | −102.3 (19.4) | −30.5 (26.9) | .033 |
| LS mean (SE) difference, mmHg | −71.7 (33.2) | ||
| 95% CI of LS mean difference, mmHg | −137.7 to −5.8 | ||
| Percentage change from baseline P(A–a)O2, up-to-day 6, mean (SD)a | −30.9 (72.0) | −5.2 (91.0) | |
| Patients with improvement of P(A–a)O2 | |||
| Any improvement, n (%) | 53 (84.1) | 21 (63.6) | .023 |
| ≥50% improvement, n (%) | 33 (52.4) | 10 (30.3) | .039 |
| ≥33% improvement, n (%) | 37 (58.7) | 15 (45.5) | .22 |
| Patients with intubation (mechanical ventilation) by day 14, n/N (%) | 9/78 (11.5) | 7b/44 (15.9) | .49 |
Abbreviations: ECMO = extracorporeal membrane oxygenation; LS = least squares; P(A–a)O2 = alveolar–arterial oxygen gradient; SE = standard error; SOC = standard of care.
Primary outcomes are in bold.
a
The percent change in P(A–a)O2 was calculated for each patient as the change from baseline divided by the baseline value. Then, summary statistics were generated.
b
Two patients also received ECMO.