Table 3.
Analysis of the WHO OSCI during the dosing period
|
Intention-to-treat population |
Per-protocol population |
|||
|---|---|---|---|---|
| Ratio (95% CI) | p value | Ratio (95% CI) | p value | |
| Odds of improvement on the OSCI | OR 2·32 (1·07–5·04) | 0·033 | OR 2·80 (1·21–6·52) | 0·017 |
| Time to severe disease or death (OSCI ≥5) | HR 0·50 (0·18–1·38) | 0·179 | Not calculated | .. |
| Odds of severe disease or death (OSCI ≥5) | OR 0·28 (0·07–1·08) | 0·064* | OR 0·18 (0·04–0·93) | 0·041* |
| Time to intubation or death (OSCI ≥6) | HR 0·38 (0·09–1·65) | 0·198 | Not calculated | .. |
| Odds of intubation or death (OSCI ≥6) | OR 0·42 (0·09–1·83) | 0·246* | OR 0·31 (0·05–1·79) | 0·189* |
| Time to recovery | HR 2·19 (1·03–4·69) | 0·043 | HR 2·29 (1·07–4·91) | 0·033 |
| Odds of recovery | OR 3·19 (1·24–8·24) | 0·017 | OR 3·18 (1·21–8·39) | 0·019 |
| Time to hospital discharge | HR 1·37 (0·85–2·20) | 0·196 | HR 1·53 (0·96–2·42) | 0·072 |
| Odds of hospital discharge | OR 1·63 (0·61–4·35) | 0·330 | OR 2·14 (0·64–7·12) | 0·215 |
ORs relate to the end-of-treatment visit on day 15 or 16. Time-to-event analyses include all data up to and including the end-of-treatment visit. Recovery was defined as a post-baseline OSCI score of 0 or 1, which does not rise above 1 at any subsequent visits. Hospital discharge was defined as a post-baseline OSCI score of 2 or less, which does not rise above 2 at any subsequent visits. Three patients died during the study; all deaths occurred in patients randomly assigned to placebo, so no modelling analysis was done. OSCI=Ordinal Scale for Clinical Improvement. OR=odds ratio. HR=hazard ratio.
Post-hoc analysis done by use of Firth logistic regression analysis.