Table 2. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population.*.
| Overall | Ordinal Score at Baseline | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 4 | 5 | 6 | 7 | |||||||
| Remdesivir (N=541) |
Placebo (N=521) |
Remdesivir (N=75) |
Placebo (N=63) |
Remdesivir (N=232) |
Placebo (N=203) |
Remdesivir (N=95) |
Placebo (N=98) |
Remdesivir (N=131) |
Placebo (N=154) |
|
| Recovery | ||||||||||
| No. of recoveries | 399 | 352 | 73 | 58 | 206 | 156 | 57 | 61 | 63 | 77 |
| Median time to recovery (95% CI) — days | 10 (9–11) | 15 (13–18) | 5 (4–6) | 6 (4–7) | 7 (6–8) | 9 (7–10) | 15 (10– 27) | 20 (14– 26) | 29 (24–NE) | 28 (24–NE) |
| Rate ratio (95% CI)† | 1.29 (1.12–1.49 [P<0.001]) | 1.29 (0.91–1.83) | 1.45 (1.18–1.79) | 1.09 (0.76–1.57) | 0.98 (0.70–1.36) | |||||
| Mortality through day 14‡ | ||||||||||
| Hazard ratio for data through day 15 (95% CI) | 0.55 (0.36–0.83) | 0.42 (0.04–4.67) | 0.28 (0.12–0.66) | 0.82 (0.40–1.69) | 0.76 (0.39–1.50) | |||||
| No. of deaths by day 15 | 35 | 61 | 1 | 2 | 7 | 21 | 13 | 17 | 14 | 21 |
| Kaplan–Meier estimate of mortality by day 15 — % (95% CI) | 6.7 (4.8–9.2) |
11.9 (9.4–15.0) |
1.3 (0.2–9.1) |
3.2 (0.8–12.1) |
3.1 (1.5–6.4) |
10.5 (7.0–15.7) |
14.2 (8.5–23.2) |
17.3 (11.2–26.4) |
10.9 (6.6–17.6) |
13.8 (9.2–20.4) |
| Mortality over entire study period‡ | ||||||||||
| Hazard ratio (95% CI) | 0.73 (0.52–1.03) | 0.82 (0.17–4.07) | 0.30 (0.14–0.64) | 1.02 (0.54–1.91) | 1.13 (0.67–1.89) | |||||
| No. of deaths by day 29 | 59 | 77 | 3 | 3 | 9 | 25 | 19 | 20 | 28 | 29 |
| Kaplan–Meier estimate of mortality by day 29 — % (95% CI) | 11.4 (9.0–14.5) |
15.2 (12.3–18.6) |
4.1 (1.3– 12.1) |
4.8 (1.6–14.3) |
4.0 (2.1–7.5) |
12.7 (8.8–18.3) |
21.2 (14.0–31.2) |
20.4 (13.7–29.8) |
21.9 (15.7–30.1) |
19.3 (13.8–26.5) |
| Ordinal score at day 15 (±2 days) — no. (%)§ | ||||||||||
| 1 | 157 (29.0) | 115 (22.1) | 38 (50.7) | 28 (44.4) | 90 (38.8) | 62 (30.5) | 18 (18.9) | 14 (14.3) | 11 (8.4) | 11 (7.1) |
| 2 | 117 (21.6) | 102 (19.6) | 20 (26.7) | 15 (23.8) | 70 (30.2) | 58 (28.6) | 22 (23.2) | 19 (19.4) | 5 (3.8) | 10 (6.5) |
| 3 | 14 (2.6) | 8 (1.5) | 8 (10.7) | 4 (6.3) | 6 (2.6) | 4 (2.0) | 0 | 0 | 0 | 0 |
| 4 | 38 (7.0) | 33 (6.3) | 3 (4.0) | 7 (11.1) | 17 (7.3) | 13 (6.4) | 12 (12.6) | 4 (4.1) | 6 (4.6) | 9 (5.8) |
| 5 | 58 (10.7) | 60 (11.5) | 3 (4.0) | 5 (7.9) | 25 (10.8) | 18 (8.9) | 2 (2.1) | 14 (14.3) | 28 (21.4) | 23 (14.9) |
| 6 | 28 (5.2) | 24 (4.6) | 1 (1.3) | 0 | 5 (2.2) | 7 (3.4) | 12 (12.6) | 11 (11.2) | 10 (7.6) | 6 (3.9) |
| 7 | 95 (17.6) | 121 (23.2) | 1 (1.3) | 3 (4.8) | 13 (5.6) | 21 (10.3) | 16 (16.8) | 20 (20.4) | 57 (43.5) | 74 (48.1) |
| 8 | 34 (6.3) | 58 (11.1) | 1 (1.3) | 1 (1.6) | 6 (2.6) | 20 (9.9) | 13 (13.7) | 16 (16.3) | 14 (10.7) | 21 (13.6) |
| Odds ratio (95% CI) | 1.5 (1.2–1.9) | 1.5 (0.8–2.7) | 1.6 (1.2–2.3) | 1.4 (0.9–2.3) | 1.2 (0.8–1.9) | |||||
P values and confidence intervals have not been adjusted for multiple comparisons. NE denotes not possible to estimate.
Recovery rate ratios and hazard ratios were calculated from the stratified Cox model; the P value for this ratio was calculated with the stratified log-rank test (overall model stratified by actual disease severity). Recovery rate ratios greater than 1 indicate a benefit with remdesivir; hazard ratios less than 1 indicate a benefit with remdesivir.
Mortality over the first 14 days includes data from all patients who were still alive through 14 days postenrollment, with data censored on day 15, as if 14 days was the maximum follow-up time. Mortality over the entire study period uses the totality of the study data and censors data from patients who completed follow-up alive at 28 days postenrollment.
The ordinal score at day 15 is the patient’s worst score on the ordinal scale during the previous day. Four patients died 15 days after randomization and are recorded as having died for the ordinal score at the day 15 outcome but not for the mortality day 15 outcome. Scores on the ordinal scale are as follows: 1, not hospitalized, no limitations of activities; 2, not hospitalized, limitation of activities, home oxygen requirement, or both; 3, hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control reasons); 4, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (Covid-19–related or other medical conditions); 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and 8, death. Odds ratios and P values were calculated with the use of a proportional odds model (overall model adjusted for actual disease severity). Odds ratio values greater than 1 indicate a benefit with remdesivir.