Table 2 Primary and secondary efficacy endpoints
All patients (N = 86) | Group A (N = 43) | Group B (N = 43) | p-value | |
|---|---|---|---|---|
RR < 23/min for at least 24 h, on Day 7, n (%) | 72 (83.7) | 36 (83.7) | 36 (83.7) | > 0.999 |
SpO2 ≥ 94% on room air for at least 24 h, on Day 7, n (%) | 55 (64.0) | 25 (58.1) | 30 (69.8) | 0.261 |
Decrease by 50% in either of the inflammatory markers2 from baseline to Day 7, n (%) | 72 (82.8) | 35 (81.4) | 37 (84.1) | 0.739 |
NIAID-OS, on Day 7, n (%) | ||||
1 | 5 (6.1) | 2 (5.0) | 3 (7.1) | |
3 | 26 (31.7) | 12 (30.0) | 14 (33.3) | |
4 | 17 (20.7) | 8 (20.0) | 9 (21.4) | 0.975 |
5 | 21 (25.6) | 11 (27.5) | 10 (23.8) | |
6 | 13 (15.9) | 7 (17.5) | 6 (14.4) | |
Change in the NIAID-OS score from baseline to Day 7, median (IQR) | − 1 (− 2–0) | − 1 (− 2–0) | − 1 (− 2–0) | 0.537 |
Time to improvement3 by at least 1 point in any of the COVID-19 clinical severity ordinal scales, median (95% CI) | 6 (5.2–6.8) | 6 (5.1–6.9) | 4 (2.9–5.1) | 0.462 |
Decrease > 2 breaths/min in RR from baseline to Day 7, n (%) | 34 (39.5) | 14 (32.5) | 20 (46.5) | 0.120 |
Increase > 2% of SpO2 values from baseline to Day 7, n (%) | 28 (32.5) | 14 (32.6) | 14 (32.6) | 0.839 |
Ready to be discharged3, days, median (95% CI) | 7 (6–8) | 7 (5.9–8.1) | 7 (6.1–7.9) | 0.851 |
ICU admission up to Day 7, n (%) | 1 (1.2) | 1 (2.3) | 0 | > 0.999 |
Death outcome, n (%) | 1 (1.2) | 1 (2.3) | 0 | > 0.999 |