There was no clinical benefit from use of lopinavir-ritonavir in hospitalised COVID-19 patients studied in the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial, according to a statement from the trial’s chief investigators.
In March 2020, the randomised RECOVERY clinical trial was established to test a range of potential treatments for COVID-19, including lopinavir-ritonavir (an antiviral treatment commonly used to treat HIV). Over 11,800 patients have been enrolled from 176 NHS hospitals in the UK.
On 25 June 2020, the independent Data Monitoring Committee conducted a routine review of the emerging data and recommended that the chief investigators be unblinded to the results for the lopinavir-ritonavir arm.
Yesterday, the trial Steering Committee concluded that there is no beneficial effect of lopinavir-ritonavir in patients hospitalised with COVID-19 and closed randomisation to that treatment arm.
A total of 1596 patients were randomly assigned to lopinavir-ritonavir and compared with 3376 patients randomly assigned to usual care alone. Of these patients, 4 per cent required invasive mechanical ventilation when they entered the trial, 70 per cent required oxygen alone and 26 per cent did not require any respiratory intervention.
There was no significant difference in the primary endpoint of 28-day mortality (22.1% with lopinavir-ritonavir vs 21.3% with usual care; relative risk, 1.04 [95% CI, 0.91- 1.18]; P=.58), and the results were consistent in different patient subgroups. There was also no evidence of beneficial effects on the risk of progression to mechanical ventilation or length of hospital stay.
“These data convincingly rule out any meaningful mortality benefit of lopinavir-ritonavir in the hospitalised COVID-19 patients we studied. We were unable to study a large number of patients on invasive mechanical ventilation because of difficulty administering the drug to patients on ventilators. As such, we cannot make conclusions about the effectiveness in mechanically ventilated patients,” said the chief investigators.
RECOVERY continues to enrol patients to study azithromycin, tocilizumab and convalescent plasma use in COVID-19 patients.