Table 3.
Primary and Secondary Clinical Outcomes
| Outcome | Itraconazole (N=32) | Standard Care (N=33) | Treatment Effect | Estimate (95% CI) |
|---|---|---|---|---|
| Cumulative status on day 15 – mean (SD) | 49 (20) | 47 (17) | Ratio of geometric means | 1.01 (0.85 to 1.19) |
| Time to sustained clinical improvement - median [days] - median (IQR) | 10 (5 to 18) | 9 (5 to6) | Subdistribution HR | 0.94 (0.56 to 1.60) |
| Day 28 mortality – no. (%) | 0 (0%) | 0 (0%) | HR | |
| Time to weaning from oxygen [days] – median (IQR) # | 5 (2 to 15) | 4 (1 to 8) | Subdistribution HR | 0.76 (0.46 to 1.25) |
| Hospital stay [days] – median (IQR) | 8 (4 to 17) | 9 (4 to 16) | Subdistribution HR | 0.92 (0.55 to 1.53) |
| ICU stay [days] – median (IQR) * | 14 (8 to 22) | 12 (9 to 18) | Subdistribution HR | 0.76 (0.34 to 1.70) |
| Duration of mechanical ventilation – median (IQR) * | 12 (8 to 16) | 11 (7 to 12) | Subdistribution HR | 0.37 (0.11 to 1.29) |
| Clinical Status on day 15– no. (%) | Common Odds Ratio | 1.21 (0.47 to 2.87) | ||
| 1: Not hospitalized, no limitations on activities | 10 (31%) | 7 (23%) | ||
| 2: Not hospitalized, limitations on activities | 12 (38%) | 14 (45%) | ||
| 3: Hospitalized, not requiring supplemental oxygen | 1 (3%) | 3 (10%) | ||
| 4: Hospitalized, requiring supplemental oxygen | 4 (13%) | 3 (10%) | ||
| 5: Hospitalized, on non-invasive ventilation or high flow oxygen devices | 1 (3%) | 2 (7%) | ||
| 6: Hospitalized, requiring ECMO, invasive mechanical ventilation, or both | 4 (13%) | 2 (7%) |
SD denotes standard deviation, IQR interquartile range, ECMO extracorporeal membrane oxygenation
# includes all patients: patients who did not receive supplemental oxygen were given a duration of 0 days
* Does not include patients who were not admitted to ICU/did not receive mechanical ventilation. Hence, the difference between treatments cannot be unambiguously be attributed to treatment