Primary outcome |
Incidence of clinical improvement or live discharge | | | | Subdistribution HR# | 1.023 (0.758–1.379) | 0.8839 |
At 15 days | CIF¶ (%) | 78.2 (69.5–84.6) | 81.3 (69.0–89.0) | | | |
At 29 days | CIF¶ (%) | 86.6 (78.9–91.6) | 89.1 (77.8–94.8) | | | |
Time to sustained clinical improvement or live discharge | Median (days) | 6 (6–8) | 8 (6–10) | | |
Secondary outcomes (compared to FAS, total n-values may be lower than n=119 for AZITHRO and n=64 for SOC due to missing values+) |
Clinical status at day 15 | n/N (%) | | | Common OR of having lower clinical status at day 15§ | 0.83 (0.47–1.53) | 0.5776 |
1) Not hosp., no limitations | | 14/97 (14.58) | 11/53 (20.75) | | | |
2) Not hosp., limitations | | 50/97 (51.55) | 28/53 (52.83) | | | |
3) Hosp., no supplemental oxygen | | 7/97 (7.22) | 2/53 (3.77) | | | |
4) Hosp., requiring oxygen | | 10/97 (10.31) | 4/53 (7.55) | | | |
5) Hosp., noninvasive ventilation | | 5/97 (5.15) | 3/53 (5.66) | | | |
6) Hospitalised, MV or ECMO | | 7/97 (7.22) | 4/53 (7.55) | | | |
7) Death | | 4/97 (4.12) | 1/53 (1.89) | | | |
Cumulative clinical status up to day 15 | Geometric meanƒ | 42.61 (39.66–45.77) | 42.60 (38.64–46.98) | Treatment ratio## | 1.00 (0.90–1.12) | 0.9508 |
All-cause mortality | | | | | | |
15 days | KM (%) | 3.4 (1.3–8.7) | 1.6 (0.2–10.6) | HR¶¶ | 1.799 (0.201–16.09) | 0.5996 |
29 days | KM (%) | 7.6 (4.0–14.0) | 6.5 (2.5–16.3) | HR¶¶ | 1.109 (0.339–3.628) | 0.8666 |
ICU (29 days) | | | | | | |
Incidence (all patients)¶¶¶ | CIF¶ (%) | 26.1 (18.5–34.2) | 23.4 (13.9–34.4) | Subdistribution HR# | 1.066 (0.572–1.985) | 0.8412 |
Duration of ICU stay (ICU admitted patients) | Median (days) | 11 (7–18) | 17 (3–28) | Subdistribution HR for live discharge from ICU# | 1.293 (0.661–2.529) | 0.4534 |
Mechanical ventilation (29 days) | | | | | | |
Incidence (all patients)¶¶¶ | CIF¶ (%) | 12.0 (6.9–18.6) | 15.6 (8.0–25.6) | Subdistribution HR# | 0.738 (0.313–1.741) | 0.4838 |
Duration of MV (MV patients) | Median (days) | 13 (NC–NC) | 19 (NC–NC) | Subdistribution HR for live weaning from MV# | 0.897 (0.263–3.034) | 0.8609 |
Supplemental oxygen (29 days) | | | | | | |
Incidence (all patients)¶¶¶ | CIF¶ (%) | 83.2 (75.1–88.9) | 79.7 (67.4–87.8) | Subdistribution HR# | 0.998 (0.837–1.191) | 0.7811 |
Duration of supplemental oxygen (patients with supplemental oxygen)# | Median (days) | 6 (5–8) | 7 (5–11) | Subdistribution HR for live weaning from oxygen# | 1.042 (0.737–1.479) | 0.9465 |
Hospital stay (29 days) | | | | Subdistribution HR for live | | |
Occurrence of live hospital discharge | CIF¶ (%) | 85.8 (78.0–91.0) | 84.4 (72.5–91.4) | hospital discharge# | 1.064 (0.780–1.451) | 0.6954 |
Duration of hospital stay (days)# | Median (days) | 7 (6–8) | 8 (6–9) | | | |
Safety outcome |
Combined cardiac end-point (hs-troponin >0.5 ng·mL−1 and/or ventricular arrhythmia requiring intervention and/or sudden cardiac death) | n/N (%) | 24/119 (20.17) | 12/64 (18.75) | OR++ | 1.40 (0.61–3.19) | 0.4265 |
Exploratory outcomes |
Normal CT at 5–7 weeks | n/N (%) | 25/75 (33.33) | 12/40 (30.00) | OR§§ | 1.56 (0.64–3.79) | 0.3233 |
DLCO % predicted | Estimated meanƒƒ (%) | 66.49 (59.96–73.02) | 67.00 (57.91–76.09) | Treatment difference### | 0.22 (−11.1–11.51) | 0.9695 |
6-min walk test | Estimated meanƒƒ (m) | 496.5 (465.0–528.0) | 456.3 (413.2–499.3) | Treatment difference### | 32.51 (−21.2–86.25) | 0.2383 |