Findings from the RECOVERY trial do not support the use of lopinavir-ritonavir to treat patients admitted to hospital with COVID-19. The combination treatment did not significantly reduce deaths, length of hospital stay or the risk of needing to be placed on a ventilator.
In the randomised, controlled, open-label, RECOVERY trial, a range of possible treatments were compared with usual care in patients admitted to hospital with COVID-19. The trial is underway at 176 hospitals in the UK.
For this study, participants were randomly allocated to either usual standard of care alone or usual standard of care plus lopinavir-ritonavir (400 mg and 100 mg, respectively) by mouth for 10 days or until discharge.
One thousand six hundred and sixteen patients were randomly allocated to receive lopinavir-ritonavir and 3424 patients to usual care. Overall, 374 (23%) patients allocated to lopinavir-ritonavir and 767 (22%) patients allocated to usual care died within 28 days (rate ratio [RR], 1.03; 95% CI, 0.91-1.17; P=.60). The results were consistent across all prespecified subgroups of patients.
There was no significant difference in time to discharge alive from hospital (median, 11 [IQR 5 to >28] days in both groups) or the proportion of patients discharged from hospital alive within 28 days (RR, 0.98; 95% CI, 0.91-1.05; P=.53).
Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (RR, 1.09; 95% CI, 0.99-1.20; P=.092).
Professor Peter Horby, from the Nuffield Department of Medicine at the University of Oxford, UK, co-Chief Investigator of the RECOVERY trial, said: “The result from the RECOVERY trial is clear. When combined with findings from an earlier, smaller trial and with the WHO interim results, this provides strong evidence that lopinavir-ritonavir is not an effective treatment for patients hospitalised with COVID-19.”
“Whilst it is disappointing that there was no significant benefit from lopinavir-ritonavir for patients in hospital, these findings have allowed us to focus our efforts on other promising treatments, and have informed the way in which individual patients are treated.”
The findings are published in the Lancet.
