Table 2.
Primary and secondary outcomes by analysis population and subgroup
| Point estimate (95% CI) | |
|---|---|
| Primary endpoint, time to clinical improvement | |
| Interim analysis (n=197) | 1·61 (1·16–2·23) |
| All randomised participants (n=234) | 1·40 (1·02–1·92) |
| Subgroup analyses of time to clinical improvement for all randomised participants | |
| Baseline NIAID-OS score of 2 | NA (NA–NA)* |
| Baseline NIAID-OS score of 3 | 1·21 (0·75–1·94) |
| Baseline NIAID-OS score of 4 | 1·85 (1·19–2·87) |
| Baseline NIAID-OS score of 3 or 4 | 1·46 (1·06–2·00) |
| Concomitant corticosteroids | 1·46 (1·02–2·09) |
| Concomitant remdesivir | 1·44 (0·98–2·14) |
| No concomitant corticosteroids or remdesivir | 1·51 (0·50–4·55) |
| Secondary time-to-event analyses for all randomised participants | |
| Time to hospital discharge | 1·42 (1·03–1·95) |
| Time to disease progression† | 0·56 (0·33–0·95) |
| Time to intubation† | 0·53 (0·29–0·94) |
| Death or respiratory failure by day 29 in all randomised participants | |
| CD24Fc group | 26 (22%; 15–31) |
| Placebo group | 33 (28%; 20–37) |
| All-cause mortality by day 29 in all randomised participants | |
| CD24Fc group | 16 (14%; 8–21) |
| Placebo group | 18 (15%; 9–23) |
| Participants requiring intubation by day 29 in all randomised participants | |
| CD24Fc group | 18 (15%; NA–NA) |
| Placebo group | 32 (27%; NA–NA) |
Point estimates are HR or n (%). HRs are for CD24Fc group versus placebo group. NIAID-OS=National Institute of Allergy and Infectious Diseases 8-point ordinal scale. NA=not available. HR=hazard ratio.
*
Analysis was not performed because of small number of participants (n=4) with baseline NIAID-OS score of 2.
†
Time to event analysed as rate of events comparison; HR less than 1 favours CD24Fc.