Table 2.
Primary and secondary outcomes in the intention-to-treat population of the DisCoVeRy trial, overall, according to treatment group and COVID-19 severity at random assignment
|
Overall (n=832) |
Moderate COVID-19 (n=504) |
Severe COVID-19 (n=328) |
Remdesivir vs control, effect measure (95% CI); p value | |||||
|---|---|---|---|---|---|---|---|---|
| Remdesivir group (n=414) | Control group (n=418) | Remdesivir group (n=253) | Control group (n=251) | Remdesivir group (n=161) | Control group (n=167) | |||
| 7-point ordinal scale at day 15 | .. | .. | .. | .. | .. | .. | OR 0·98 (0·77 to 1·25); p=0·85 | |
| 1: not hospitalised, no limitations on activities | 61 (15%) | 73 (18%) | 51 (20%) | 61 (24%) | 10 (6%) | 12 (7%) | .. | |
| 2: not hospitalised, limitation on activities | 129 (31%) | 132 (32%) | 101 (40%) | 106 (42%) | 28 (17%) | 26 (16%) | .. | |
| 3: hospitalised, not requiring supplemental oxygen | 50 (12%) | 29 (7%) | 34 (13%) | 15 (6%) | 16 (10%) | 14 (8%) | .. | |
| 4: hospitalised, requiring supplemental oxygen | 76 (18%) | 67 (16%) | 41 (16%) | 36 (14%) | 35 (22%) | 31 (18%) | .. | |
| 5: hospitalised, on non-invasive ventilation or high flow oxygen devices | 15 (4%) | 14 (3%) | 2 (1%) | 6 (3%) | 13 (8%) | 8 (5%) | .. | |
| 6: hospitalised, on invasive mechanical ventilation or ECMO | 62 (15%) | 79 (19%) | 15 (6%) | 16 (6%) | 47 (29%) | 63 (38%) | .. | |
| 7: death | 21 (5%) | 24 (6%) | 9 (4%) | 11 (5%) | 12 (8%) | 13 (8%) | .. | |
| 7-point ordinal scale at day 29 | .. | .. | .. | .. | .. | .. | OR 1·11 (0·87 to 1·42); p=0·39 | |
| 1: not hospitalised, no limitations on activities | 109 (26%) | 122 (29%) | 82 (33%) | 94 (38%) | 27 (17%) | 28 (17%) | .. | |
| 2: not hospitalised, limitation on activities | 156 (38%) | 119 (28%) | 104 (41%) | 88 (35%) | 52 (32%) | 31 (19%) | .. | |
| 3: hospitalised, not requiring supplemental oxygen | 47 (11%) | 50 (12%) | 26 (10%) | 23 (9%) | 21 (13%) | 27 (16%) | .. | |
| 4: hospitalised, requiring supplemental oxygen | 36 (9%) | 41 (10%) | 18 (7%) | 21 (8%) | 18 (11%) | 20 (12%) | .. | |
| 5: hospitalised, on non-invasive ventilation or high flow oxygen devices | 6 (2%) | 7 (2%) | 0 (0%) | 3 (1%) | 6 (4%) | 4 (2%) | .. | |
| 6: hospitalised, on invasive mechanical ventilation or ECMO | 26 (6%) | 41 (10%) | 8 (3%) | 7 (3%) | 18 (11%) | 34 (20%) | .. | |
| 7: death | 34 (8%) | 38 (9%) | 15 (6%) | 15 (6%) | 19 (12%) | 23 (14%) | .. | |
| Days to improvement of two categories of the 7-point ordinal scale or hospital discharge within day 29 | 12 (8 to 24) | 11 (7 to 26) | 11 (8 to 20) | 9 (6 to 15) | 16 (10 to 29) | 17 (10 to 29) | HR 0·92 (0·79 to 1·08); p=0·30 | |
| Change from baseline in NEWS-2 to day 3 | 0 (−2 to 1) | 0 (−2 to 2) | −1 (−2 to 1) | 0 (−2 to 1) | 0 (−2 to 2) | 0 (−2 to 2) | LSMD 0·09 (−0·36 to 0·55); p=0·69 | |
| Change from baseline in NEWS-2 to day 8 | −2 (−4 to 1) | −1 (−4 to 1) | −2 (−5 to 0) | −2 (−4 to 0) | 0 (−3 to 1) | 0 (−3 to 2) | LSMD −0·12 (−0·71 to 0·47); p=0·70 | |
| Days to NEWS-2 ≤2 or hospital discharge within 29 days | 11 (7 to 24) | 11 (6 to 29) | 9 (5 to 14) | 8 (5 to 13) | 20 (12 to 29) | 26 (12 to 29) | HR 1·03 (0·88 to 1·21); p=0·74 | |
| Days to hospital discharge within 29 days | 15 (10 to 29) | 13 (8 to 29) | 11 (8 to 25) | 10 (7 to 22) | 24 (13 to 29) | 29 (13 to 29) | HR 0·94 (0·80 to 1·11); p=0·49 | |
| New mechanical ventilation, ECMO, or death within 29 days* | 60/339 (18%) | 87/344 (25%) | 35/253 (14%) | 40/251 (16%) | 25/86 (29%) | 47/93 (51%) | HR 0·66 (0·47 to 0·91); p=0·010 | |
| Oxygenation-free days until day 29 | 17 (2 to 22) | 17 (0 to 23) | 21 (14 to 24) | 21 (11 to 25) | 10 (0 to 17) | 5 (0 to 18) | LSMD 0·35 (−0·90 to 1·60); p=0·59 | |
| Ventilator-free days until day 29 | 29 (20 to 29) | 29 (16 to 29) | 29 (29 to 29) | 29 (29 to 29) | 21 (6 to 29) | 17 (2 to 29) | LSMD 1·08 (−0·15 to 2·30); p=0·080 | |
| Death within 28 days | 34 (8%) | 37 (9%) | 15 (6%) | 15 (6%) | 19 (12%) | 22 (13%) | OR 0·93 (0·57 to 1·52); p=0·77 | |
Data are n (%), median (IQR), or n/N (%), except where otherwise stated. Analyses were stratified on the disease severity at random assignment and adjusted effect measures are reported. For the ordinal scale results, an OR greater than 1 is in the direction of remdesivir conferring benefit over standard of care alone. For time to new mechanical ventilation, ECMO, or death within 29 days, an HR less than 1 is in the direction of remdesivir conferring benefit over standard of care alone. For other time to event analyses, an HR greater than 1 is in the direction of remdesivir conferring benefit over standard of care alone. ECMO=extracorporeal membrane oxygenation. HR=hazard ratio. LSMD=least-square mean difference. OR=odds ratio.
This outcome was evaluated only in participants not under mechanical ventilation or ECMO at random assignment; among the 147 participants with occurrence of new mechanical ventilation, ECMO, or death within 29 days, 49 died (24 [7%] of 339 in the remdesivir group, 25 [7%] of 344 in the control group), all of whom were mechanically ventilated before death; because incidence of new mechanical ventilation, ECMO, or death was less than 50%, incidences are reported instead of median times.