The HIV treatment Kaletra (lopinavir/ritonavir) was found to lack a beneficial effect in hospitalized COVID-19 patients, according to the third set of results from the “Randomised Evaluation of COVID-19 Therapy” (RECOVERY) trial.
The RECOVERY trial’s chief investigators said in a statement published on June 29th that a data review demonstrated that Kaletra demonstrated zero clinical benefit in patients hospitalized with COVID-19 compared to only standard care.
The RECOVERY trial involved over 11,800 patients. 1,596 of the patients were randomly placed in a group which received Kaletra. The results from this group were then compared with the results from a group of 3,376 patients who were randomly selected to receive only standard care.
Four percent of the randomized patients needed invasive mechanical ventilation upon entering the trial. 70 percent required only oxygen and 26 percent did not require respiratory intervention at all.
No significant difference was found across all patient subgroups between Kaletra and standard care with regards to the amount of patients who died at 28 days (22.1 percent for the Kaletra group, 21.3 percent for the standard care group).
There was also no evidence that Kaletra had any beneficial effect on the length of hospital stay or the risk of progression to mechanical ventilation.
“These preliminary results show that for patients hospitalized with COVID-19 and not on a ventilator, lopinavir/ritonavir is not an effective treatment,” said Peter Horby of the University of Oxford.
The University of Oxford’s Martin Landray said the “clear results” demonstrated how valuable large randomized clinical trials are in showing which drugs that are hoped to work actually work.
“In many countries, current guidelines recommend lopinavir/ritonavir as a treatment for COVID-19. The results from this trial, together with those from other large randomised trials, should inform revisions to those guidelines and changes to the way individual patients are treated,” Landray said.
RECOVERY continues to enroll patients for the purpose of studying convalescent plasma, tocilizumab and azithromycin regarding COVID-19 treatment. It is expected that the study will include other treatments in the future.
Kaletra had earlier shown promise for COVID-19 treatment when Australian researchers said it caused a “disappearance of the virus” and that it wasn’t an exaggeration to label the treatment a “treatment or cure” for COVID-19.
Over 10.6 million cases of COVID-19 have been reported in over 188 countries and territories, leading to over 516,000 deaths.