Table 3.
Outcomes in the intention-to-treat population
| Remdesivir group (n=158) | Placebo group (n=78) | Difference* | ||
|---|---|---|---|---|
| Time to clinical improvement | 21·0 (13·0 to 28·0) | 23·0 (15·0 to 28·0) | 1·23 (0·87 to 1·75)† | |
| Day 28 mortality | 22 (14%) | 10 (13%) | 1·1% (−8·1 to 10·3) | |
| Early (≤10 days of symptom onset) | 8/71 (11%) | 7/47 (15%) | −3·6% (−16·2 to 8·9) | |
| Late (>10 days of symptom onset) | 12/84 (14%) | 3/31 (10%) | 4·6% (−8·2 to 17·4) | |
| Clinical improvement rates | ||||
| Day 7 | 4 (3%) | 2 (3%) | 0·0% (−4·3 to 4·2) | |
| Day 14 | 42 (27%) | 18 (23%) | 3·5% (−8·1 to 15·1) | |
| Day 28 | 103 (65%) | 45 (58%) | 7·5% (−5·7 to 20·7) | |
| Duration of invasive mechanical ventilation, days | 7·0 (4·0 to 16·0) | 15·5 (6·0 to 21·0) | −4·0 (−14·0 to 2·0) | |
| Duration of invasive mechanical ventilation in survivors, days‡ | 19·0 (5·0 to 42·0) | 42·0 (17·0 to 46·0) | −12·0 (−41·0 to 25·0) | |
| Duration of invasive mechanical ventilation in non-survivors, days‡ | 7·0 (2·0 to 11·0) | 8·0 (5·0 to 16·0) | −2·5 (−11·0 to 3·0) | |
| Duration of oxygen support, days | 19·0 (11·0 to 30·0) | 21·0 (14·0 to 30·5) | −2·0 (−6·0 to 1·0) | |
| Duration of hospital stay, days | 25·0 (16·0 to 38·0) | 24·0 (18·0 to 36·0) | 0·0 (−4·0 to 4·0) | |
| Time from random group assignment to discharge, days | 21·0 (12·0 to 31·0) | 21·0 (13·5 to 28·5) | 0·0 (−3·0 to 3·0) | |
| Time from random group assignment to death, days | 9·5 (6·0 to 18·5) | 11·0 (7·0 to 18·0) | −1·0 (−7·0 to 5·0) | |
| Six-category scale at day 7 | ||||
| 1—discharge (alive) | 4/154 (3%) | 2/77 (3%) | OR 0·69 (0·41 to 1·17)§ | |
| 2—hospital admission, not requiring supplemental oxygen | 21/154 (14%) | 16/77 (21%) | .. | |
| 3—hospital admission, requiring supplemental oxygen | 87/154 (56%) | 43/77 (56%) | .. | |
| 4—hospital admission, requiring high-flow nasal cannula or non-invasive mechanical ventilation | 26/154 (17%) | 8/77 (10%) | .. | |
| 5—hospital admission, requiring extracorporeal membrane oxygenation or invasive mechanical ventilation | 6/154 (4%) | 4/77 (5%) | .. | |
| 6—death | 10/154 (6%) | 4/77 (5%) | .. | |
| Six-category scale at day 14 | ||||
| 1—discharge (alive) | 39/153 (25%) | 18/78 (23%) | OR 1·25 (0·76 to 2·04)§ | |
| 2—hospital admission, not requiring supplemental oxygen | 21/153 (14%) | 10/78 (13%) | .. | |
| 3—hospital admission, requiring supplemental oxygen | 61/153 (40%) | 28/78 (36%) | .. | |
| 4—hospital admission, requiring high-flow nasal cannula or non-invasive mechanical ventilation | 13/153 (8%) | 8/78 (10%) | .. | |
| 5—hospital admission, requiring extracorporeal membrane oxygenation or invasive mechanical ventilation | 4/153 (3%) | 7/78 (9%) | .. | |
| 6—death | 15/153 (10%) | 7/78 (9%) | .. | |
| Six-category scale at day 28 | ||||
| 1—discharge (alive) | 92/150 (61%) | 45/77 (58%) | OR 1·15 (0·67 to 1·96)§ | |
| 2—hospital admission, not requiring supplemental oxygen | 14/150 (9%) | 4/77 (5%) | .. | |
| 3—hospital admission, requiring supplemental oxygen | 18/150 (12%) | 13/77 (17%) | .. | |
| 4—hospital admission, requiring high-flow nasal cannula or non-invasive mechanical ventilation | 2/150 (1%) | 2/77 (3%) | .. | |
| 5—hospital admission, requiring extracorporeal membrane oxygenation or invasive mechanical ventilation | 2/150 (1%) | 3/77 (4%) | .. | |
| 6—death | 22/150 (15%) | 10/77 (13%) | .. | |
Data are median (IQR), n (%), or n/N (%). Clinical improvement (the event) was defined as a decline of two categories on the modified six-category ordinal scale of clinical status, or hospital discharge. OR=odds ratio.
*
Differences are expressed as rate differences or Hodges-Lehmann estimator and 95% CI.
†
Hazard ratio and 95% CI estimated by Cox proportional risk model.
‡
Three patients in each group were survivors and ten patients in the remdesivir group and seven patients in the placebo group were non-survivors.
§
Calculated by ordinal logistic regression model.