Trial Primary and Secondary Endpoints – Full Analysis Set (FAS)
| Full Analysis Set (n=483) | |||||
| Primary and secondary endpoints | Statistic | Estimate (95% Confidence Interval) | Treatment Effect | Estimate (95% CI) | |
| Plasma | SOC | ||||
| Alive and free of MV at 15 Days | % | 83.7 (79.3; 87.4) | 84.1 (77.6; 88.9) | Odds Ratio | 0.99 (0.59; 1.68) |
| Alive and free of MV at 30 Days | KM [%] | 82.5 (78.1; 86.4) | 82.2 (76.0; 87.6) | Hazard Ratio | 0.94 (0.60; 1.48) |
| Sustained Improvement or Discharge within 30 Days | CIF [%] | 82.6 (77.9; 86.3) | 84.7 (78.1; 89.4) | Subdistribution HR | 0.98 (0.81; 1.20) |
| Hospital Discharge (30 Days) | CIF [%] | 80.5 (75.7; 84.4) | 79.8 (72.8; 85.2) | Subdistribution HR | 1.06 (0.87; 1.30) |
| All-Cause Mortality | |||||
| Day 15 | KM [%] | 3.1 (1.7; 5.8) | 4.9 (2.5; 9.6) | Hazard Ratio | 0.61 (0.24; 1.54) |
| Day 30 | KM [%] | 9.1 (6.3; 12.9) | 8.7 (5.3; 14.3) | Hazard Ratio | 0.99 (0.52; 1.88) |
| Supplemental Oxygen (30 Days) | |||||
| Incidence | CIF [%] | 89.5 (85.5; 92.4) | 89.0 (83.0; 92.9) | Subdistribution HR | 1.01 (0.93; 1.09) |
| Life-Weaning from SO2 | CIF [%] | 80.7 (75.6; 84.8) | 82.3 (74.9; 87.7) | Subdistribution HR | 1.05 (0.86; 1.29) |
| Mechanical Ventilation (30 Days) | |||||
| Incidence | CIF [%] | 15.0 (11.3; 19.2) | 13.5 (8.8; 19.2) | Subdistribution HR | 1.08 (0.65; 1.80) |
| Life-Weaning from MV | CIF [%] | 58.4 (42.1; 71.5) | 68.2 (43.3; 83.9) | Subdistribution HR | 0.49 (0.22; 1.08) |
| ICU (30 Days) | |||||
| Admission | CIF [%] | 36.0 (30.8; 41.3) | 34.4 (27.2; 41.7) | Subdistribution HR | 1.00 (0.74; 1.34) |
| Life Discharge | CIF [%] | 78.3 (69.5; 84.8) | 82.1 (69.0; 90.1) | Subdistribution HR | 0.95 (0.66; 1.35) |
| Clinical Status | |||||
| Day 0 | Med. (IQR) | 5 (5; 5) | 5 (5; 5) | ||
| Day 15 | Med. (IQR) | 2 (0; 5) | 2 (0; 5) | Common OR | 1.09 (0.78; 1.53) |
| Day 30 | Med. (IQR) | 2 (0; 2) | 2 (0; 3) | Common OR | 0.95 (0.67; 1.33) |
| EQ-5D-5L | |||||
| Baseline | Mean (sd) | 54 (18) | 54 (18) | ||
| Day 30 | Mean (sd) | 73 (16) | 72 (17) | Mean Difference | 1.32 (-2.24; 4.88) |
| NT50 Values | |||||
| Day 0 - Log2-transformed | Med. (IQR) | 3 (1; 5) | 3 (1; 5) | ||
| Day 6 - Log2-transformed | Med. (IQR) | 6 (5; 6) | 6 (5; 6) | Mean Difference | 0.08 (-0.43; 0.58) |
| Ratio (D6/D0) - Log2-transf'd | Med. (IQR) | 2 (1; 3) | 2 (0; 4) | Mean Difference | 0.03 (-0.62; 0.68) |
KM=incidence estimated using Kaplan-Meier methodology; 95% confidence interval calculated using log(-log)-transformation. CIF=incidence estimated using Cumulative Incidence Function accounting for competing risk; sd=standard deviation; Med.=Median; IQR=Interquartile range; HR=hazard ratio; OR=odds ratio.
All estimates of treatment effects were adjusted for study site and period.
Hazard ratios were obtained using a Cox regression including factors for randomised treatment, study period and site. Subdistribution hazard ratios were obtained using a Fine&Grey regression model (accounting for competing risk) including factors for randomised treatment, study period and site. Mean differences between treatments were obtained using a general linear model including the baseline value as a covariate and factors for randomised treatment, study period and site. Common odds ratios were obtained using a proportional odds logistic regression analysis including baseline clinical status as covariate and factors for randomised treatment, study period and site.