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. 2020 Nov 12;9(2):196–206. doi: 10.1016/S2213-2600(20)30511-7

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.