No clinical benefit from use of lopinavir-ritonavir in hospitalised COVID-19 patients

The leading clinical trial, RECOVER, who are working to find effective treatments for COVID-19 have concluded that lopinavir & ritonavir (HIV anti-retrovirals commonly known as Kaletra) offer no clinical benefit to people hospitalied with COVID-19.

The RECOVER trial was set up in March 2020 to test a wide range of existing potential treatments for COVID-19, one of which was lopinavir & ritonavir (HIV anti-retrovirals commonly known as Kaletra). Over 11,800 patients from 176 NHS hospitals in the UK were enrolled into RECOVER.

On Monday 29th June 2020 the the trial’s Steering Committee, in full receipt of the trial data, concluded there was no beneficial effect of lopinavir & ritonavir to patients hospitalised with COVID-19 and closed further randomisation to that treatment arm.

Out of the over 11,800 patients enrolled to RECOVER 1596 had been randomised onto the lopinavir & ritonavir arm. Of these patients:

• 4% required invasive mechanical ventilation
• 70% required oxygen alone
• 26% did not require any respiratory intervention

There was no significant different in 28-day mortality when comparing those receiving lopinavir & ritonavir (22.1%) and those receiving standard care (21.3%). There was also no beneficial effect on the risk of progression to mechanical ventilation or length of hospital stay. 

Peter Horby, Professor of Emerging Infectious Diseases and Global Health at the Nuffield Department of Medicine, University of Oxford, and Chief Investigator for the trial said:

‘Today we release the third set of results from the RECOVERY trial. These preliminary results show that for patients hospitalised with COVID-19 and not on a ventilator, lopinavir-ritonavir is not an effective treatment. 

In 100 days, the RECOVERY trial has provided results enabling change in global practice three times. This extraordinary national effort has shown that two drugs used to treat hospitalised COVID patients throughout the world, hydroxychloroquine and lopinavir-ritonavir, do not improve survival, whilst one drug that was not recommended, dexamethasone, saves lives.

RECOVERY continues to enrol patients to allow the study of azithromycin, tocilizumab, and convalescent plasma. It is anticipated that other treatments will be included for study in the future.