TABLE 2.
Trial primary and secondary end-points: Full Analysis Set (n=483)
| Statistic | Estimate (95% CI) | Treatment effect | Estimate (95% CI) | ||
| Plasma | SOC | ||||
| Alive and free of mechanical ventilation at 15 days | % | 83.7 (79.3–87.4) | 84.1 (77.6–88.9) | OR | 0.99 (0.59–1.68) |
| Alive and free of mechanical ventilation at 30 days | KM (%) | 82.5 (78.1–86.4) | 82.2 (76.0–87.6) | HR | 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) | HR | 0.61 (0.24–1.54) |
| Day 30 | KM (%) | 9.1 (6.3–12.9) | 8.7 (5.3–14.3) | HR | 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 supplemental oxygen | 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 mechanical ventilation | 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 | Median (IQR) | 5 (5–5) | 5 (5–5) | ||
| Day 15 | Median (IQR) | 2 (0–5) | 2 (0–5) | Common OR | 1.09 (0.78–1.53) |
| Day 30 | Median (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) | Median (IQR) | 3 (1–5) | 3 (1–5) | ||
| Day 6 (log2-transformed) | Median (IQR) | 6 (5–6) | 6 (5–6) | Mean difference | 0.08 (−0.43–0.58) |
| Ratio day 6/day 0 (log2-transformed) | Median (IQR) | 2 (1–3) | 2 (0–4) | Mean difference | 0.03 (−0.62–0.68) |
SOC: standard of care; ICU: intensive care unit; NT50: 50% neutralisation titre; KM: incidence estimated using Kaplan–Meier methodology; 95% CI: 95% confidence interval calculated using log(−log) transformation; CIF: incidence estimated using the cumulative incidence function accounting for competing risks; 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–Gray regression model (accounting for competing risks) including factors for randomised treatment, study period and site. Mean differences between treatments were obtained using a general linear model including 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 a covariate and factors for randomised treatment, study period and site.