Table 3. Outcomes in the Intention-to-Treat Population.*.
| Characteristic | Total (N=199) |
Lopinavir–Ritonavir (N=99) |
Standard Care (N=100) |
Difference† |
|---|---|---|---|---|
| Time to clinical improvement — median no. of days (IQR) | 16.0 (15.0 to 17.0) | 16.0 (13.0 to 17.0) | 16.0 (15.0 to 18.0) | 1.31 (0.95 to 1.80)‡ |
| Day 28 mortality — no. (%) | 44 (22.1) | 19 (19.2)§ | 25 (25.0) | −5.8 (−17.3 to 5.7) |
| Earlier (≤12 days after onset of symptoms) | 21 (23.3) | 8 (19.0) | 13 (27.1) | −8.0 (−25.3 to 9.3) |
| Later (>12 days after onset of symptoms) | 23 (21.1) | 11 (19.3) | 12 (23.1) | −3.8 (−19.1 to 11.6) |
| Clinical improvement — no. (%) | ||||
| Day 7 | 8 (4.0) | 6 (6.1) | 2 (2.0) | 4.1 (−1.4 to 9.5) |
| Day 14 | 75 (37.7) | 45 (45.5) | 30 (30.0) | 15.5 (2.2 to 28.8) |
| Day 28 | 148 (74.4) | 78 (78.8) | 70 (70.0) | 8.8 (−3.3 to 20.9) |
| ICU length of stay — median no. of days (IQR) | 10 (5 to 14) | 6 (2 to 11) | 11 (7 to 17) | −5 (−9 to 0) |
| Of survivors | 10 (8 to 17) | 9 (5 to 44) | 11 (9 to 14) | −1 (−16 to 38) |
| Of nonsurvivors | 10 (4 to 14) | 6 (2 to 11) | 12 (7 to 17) | −6 (−11 to 0) |
| Duration of invasive mechanical ventilation — median no. of days (IQR) | 5 (3 to 9) | 4 (3 to 7) | 5 (3 to 9) | −1 (−4 to 2) |
| Oxygen support — days (IQR) | 13 (8 to 16) | 12 (9 to 16) | 13 (6 to 16) | 0 (−2 to 2) |
| Hospital stay — median no. of days (IQR) | 15 (12 to 17) | 14 (12 to 17) | 16 (13 to 18) | 1 (0 to 2) |
| Time from randomization to discharge — median no. of days (IQR) | 13 (10 to 16) | 12 (10 to 16) | 14 (11 to 16) | 1 (0 to 3) |
| Time from randomization to death — median no. of days (IQR) | 10 (6 to 15) | 9 (6 to 13) | 12 (6 to 15) | −3 (−6 to 2) |
| Score on seven-category scale at day 7 — no. of patients (%) | ||||
| 2: Not hospitalized, but unable to resume normal activities | 4 (2.0) | 4 (4.0) | 0 | |
| 3: Hospitalization, not requiring supplemental oxygen | 29 (14.6) | 12 (12.1) | 17 (17.0) | |
| 4: Hospitalization, requiring supplemental oxygen | 109 (54.8) | 58 (58.6) | 51 (51.0) | |
| 5: Hospitalization, requiring HFNC or noninvasive mechanical ventilation | 35 (17.6) | 14 (14.1) | 21 (21.0) | |
| 6: Hospitalization, requiring ECMO, invasive mechanical ventilation, or both | 10 (5.0) | 6 (6.1) | 4 (4.0) | |
| 7: Death | 12 (6.0) | 5 (5.1) | 7 (7.0) | |
| Seven-category scale at day 14 — no. of patients (%) | ||||
| 2: Not hospitalized, but unable to resume normal activities | 71 (35.7) | 43 (43.4) | 28 (28.0) | |
| 3: Hospitalization, not requiring supplemental oxygen | 32 (16.1) | 8 (8.1) | 24 (24.0) | |
| 4: Hospitalization, requiring supplemental oxygen | 45 (22.6) | 25 (25.3) | 20 (20.0) | |
| 5: Hospitalization, requiring HFNC or noninvasive mechanical ventilation | 11 (5.5) | 5 (5.1) | 6 (6.0) | |
| 6: Hospitalization, requiring ECMO, invasive mechanical ventilation, or both | 8 (4.0) | 3 (3.0) | 5 (5.0) | |
| 7: Death | 32 (16.1) | 15 (15.2) | 17 (17.0) |
*
Clinical improvement was defined as a decline of two categories on the modified seven-category ordinal scale of clinical status, or hospital discharge. ICU denotes intensive care unit.
†
Differences were expressed as rate differences or median differences (Hodges–Lehmann estimate) and 95% confidence intervals.
‡
The hazard ratio for clinical improvement was estimated by Cox proportional-risk model.
§
This total includes 3 patients who died within 24 hours after randomization and did not receive lopinavir–ritonavir.