Table 2. Clinical Outcomes According to Remdesivir Treatment Group.
| Characteristic | 5-Day Group (N=200) |
10-Day Group (N=197) |
Baseline-Adjusted Difference (95% CI)* |
|---|---|---|---|
| Clinical status at day 14 on the 7-point ordinal scale — no. of patients (%) | P=0.14† | ||
| 1: Death | 16 (8) | 21 (11) | |
| 2: Hospitalized, receiving invasive mechanical ventilation or ECMO | 16 (8) | 33 (17) | |
| 3: Hospitalized, receiving noninvasive ventilation or high-flow oxygen | 9 (4) | 10 (5) | |
| 4: Hospitalized, requiring low-flow supplemental oxygen | 19 (10) | 14 (7) | |
| 5: Hospitalized, not receiving supplemental oxygen but requiring ongoing medical care | 11 (6) | 13 (7) | |
| 6: Hospitalized, not requiring supplemental oxygen or ongoing medical care | 9 (4) | 3 (2) | |
| 7. Not hospitalized | 120 (60) | 103 (52) | |
| Time to clinical improvement (median day of 50% cumulative incidence‡) | 10 | 11 | 0.79 (0.61 to 1.01) |
| Clinical improvement — no. of patients (%) | |||
| Day 5 | 33 (16) | 29 (15) | 0.2% (−7.0 to 7.5) |
| Day 7 | 71 (36) | 54 (27) | −5.0% (−14.0 to 4.0) |
| Day 11 | 116 (58) | 97 (49) | −4.8% (−14.1 to 4.6) |
| Day 14 | 129 (64) | 107 (54) | −6.5% (−15.7 to 2.8) |
| Time to recovery (median day of 50% cumulative incidence‡) | 10 | 11 | 0.81 (0.64 to 1.04) |
| Recovery — no. of patients (%) | |||
| Day 5 | 32 (16) | 27 (14) | 0.1% (−7.0 to 7.1) |
| Day 7 | 71 (36) | 51 (26) | −6.0% (−14.8 to 2.7) |
| Day 11 | 115 (58) | 97 (49) | −3.7% (−12.8 to 5.5) |
| Day 14 | 129 (64) | 106 (54) | −6.3% (−15.4 to 2.8) |
| Time to modified recovery (median day of 50% cumulative incidence‡) | 9 | 10 | 0.82 (0.64 to 1.04) |
| Modified recovery — no. of patients (%) | |||
| Day 5 | 51 (26) | 41 (21) | −2.3% (−10.5 to 5.9) |
| Day 7 | 84 (42) | 69 (35) | −3.4% (−12.6 to 5.8) |
| Day 11 | 128 (64) | 106 (54) | −5.7% (−14.6 to 3.2) |
| Day 14 | 140 (70) | 116 (59) | −6.7% (−15.3 to 1.9) |
Differences are expressed as rate differences, except in the case of time to clinical improvement, time to recovery, and time to modified recovery, for which differences are expressed as hazard ratios; for these time-to-event end points, the hazard ratio and its 95% confidence interval were estimated from a cause-specific proportional-hazards model including treatment and baseline clinical status as covariates. For events at prespecified time points (e.g., days 5, 7, 11, and 14), the difference in the proportion of subjects with an event under evaluation between treatment groups and the 95% confidence interval were estimated from the Mantel–Haenszel proportions adjusted according to baseline clinical status.
The P value was calculated from a Wilcoxon rank-sum test stratified by baseline clinical status.
Clinical improvement was defined as an improvement of at least 2 points from baseline on the 7-point ordinal scale; recovery was defined as an improvement from a baseline score of 2 to 5 to a score of 6 or 7; and modified recovery was defined as an improvement from a baseline score of 2 to 4 to a score of 5 to 7 or from a score of 5 to a score of 6 or 7. Cumulative incidence functions were calculated for each treatment group for days to the event under evaluation (i.e., clinical improvement, recovery, or modified recovery), with death as the competing risk. Data for patients not achieving the event under evaluation at the last assessment were censored on the day of the last clinical assessment. Patients who died before achieving the event under evaluation were considered to have experienced a competing event.