Table 2.
Primary, selected secondary, and exploratory efficacy outcomes
| Ruxolitinib (n=287) | Placebo (n=145) | Comparison (95% CI) | ||
|---|---|---|---|---|
| Primary endpoint | ||||
| Composite endpoint of death, respiratory failure requiring mechanical ventilation, or ICU care by day 29* | 34/284 (12%) | 17/144 (12%) | OR 0·91 (0·48–1·73); p=0·77 | |
| Secondary endpoints | ||||
| Mortality rate by day 29 | 9/286 (3%) | 3/145 (2%) | OR 1·21 (0·35–5·11) | |
| Respiratory failure by day 29* | 22/286 (8%) | 10/145 (7%) | OR 0·99 (0·45–2·21) | |
| ICU care by day 29*† | 30/284 (11%) | 17/144 (12%) | OR 0·81 (0·42–1·55) | |
| Change in WHO (0–8) clinical status at day 29‡ | ||||
| ≥1-point improvement | 261/286 (91%) | 136/145 (94%) | OR 0·79 (0·35–1·79) | |
| ≥2-point improvement | 252/286 (88%) | 129/145 (89%) | OR 1·00 (0·52–1·92) | |
| ≥1-point deterioration | 14/286 (5%) | 5/145 (3%) | OR 1·18 (0·40–3·49) | |
| Death by baseline clinical status by day 29†§ | ||||
| WHO (0–8) clinical status of 3 | 2/94 (2%) | 1/47 (2%) | OR 0·80 (0·10–9·53) | |
| WHO (0–8) clinical status of 4 | 7/175 (4%) | 2/93 (2%) | OR 1·35 (0·32–7·89) | |
| Duration of hospitalisation, days¶ | 9·0 (8·0–10·0) | 9·0 (8·0–12·0) | HR 1·04 (0·84–1·28) | |
| Time to hospital discharge or NEWS2 of ≤2 maintained for 24 h, days¶ | 4·0 (3·0–4·0) | 4·0 (3·0–5·0) | HR 1·02 (0·84–1·23) | |
| Exploratory endpoints | ||||
| Time to recovery (no longer infected, or ambulatory with no or minimal limitations), days†¶ | 8·0 (8·0–9·0) | 9·0 (7·0–11·0) | HR 1·10 (0·89–1·36) | |
| Time to independence from non-invasive ventilation, days | 19·0 (11·5–25·0) | 12·0 (9·0–22·0) | NA‖ | |
| Time to independence from supplementary oxygen, days | 5·5 (3·0–10·5) | 6·0 (3·0–10·0) | NA‖ | |
| Duration of ICU care, days | 9·0 (7·0–13·0) | 9·0 (4·0–21·0) | NA‖ | |
| Duration of supplementary oxygen, days | 5·0 (2·0–10·0) | 6·0 (3·0–10·0) | NA‖ | |
| Duration of invasive mechanical ventilation, days | 7·5 (5·0–16·0) | 12·0 (5·0–28·0) | NA‖ | |
Data are n/total number of patients included in the analysis (M [not model based]; [%]), median (95% CI), or median (IQR), unless otherwise specified. ORs are based on logistic regression models incorporating treatment group, region, baseline WHO (0–8) clinical status (≤3, ≥4), age, and sex as covariates. An OR of less than 1 means an event was less likely in the ruxolitinib group (which favoured ruxolitinib for all except the positive outcome events assessing ≥1-point or ≥2-point improvements in WHO (0–8) clinical status, in which an OR >1 favoured ruxolitinib). An HR of more than 1, representing higher instantaneous rates of discharge or recovery, favoured ruxolitinib. HR=hazard ratio. ICU=intensive care unit. NA=not analysed. NEWS2=National Early Warning Score 2. OR=odds ratio. WHO (0–8)=COVID-19-specific 9-point ordinal scale for clinical status proposed by WHO (appendix p 6).
Patients who developed respiratory failure or required ICU care, or both at randomisation are excluded from the analysis.
Post hoc.
Patients with missing data at day 29 were treated as non-responders.
There were no deaths in the ruxolitinib and placebo groups in patients with a baseline WHO (0–8) clinical status of 5.
Patients who did not have the event and did not die were censored at their last assessment date. Median is estimated by Kaplan-Meier method, with deaths being censored at the maximum follow-up time in the study.
Only summary statistics were conducted for these exploratory outcomes; all were evaluated on subsets of patients defined by post-baseline events, which could be confounded with treatment effect.