UK’s RECOVERY Trial Cuts Antibiotic Azithromycin, Finding No Benefit for Severe COVID-19

Researchers with the UK’s multi-armed RECOVERY trial have determined that the widely used antibiotic azithromycin was not beneficial for patients hospitalized with COVID-19 and are discontinuing their evaluation of the drug.

The randomized phase 3 study administered azithromycin to 2,582 patients while randomizing 5,182 patients to usual care, with participants on average entering the study eight days after they began having symptoms.

A preliminary analysis found no significant difference in 28-day mortality between patients on azithromycin and patients given the standard of care, the study’s primary endpoint, with both groups seeing death rates of 19 percent. Additionally, the antibiotic was not found to reduce the risk of progression to mechanical ventilation or the length of hospital stay, the researchers found, noting that the results were consistent among the different patient subgroups.

Peter Horby, the trial’s chief investigator, said Monday that although the antibiotic had been considered as a potential option for reducing lung inflammation caused by COVID-19, “our results show very clearly that for patients hospitalized with COVID-19 azithromycin is not an effective treatment.”

“While that is disappointing, it is nonetheless an important result that will guide clinical care around the world,” he said.

Follow-up has been completed for 73 percent of the azithromycin trial participants and will finish in December, after which the full results will be published in a peer-review journal.

The RECOVERY program continues to evaluate several treatments, including convalescent plasma and Regeneron’s COVID-19 antibody cocktail, both of which have received Emergency Use Authorization (EUA) from the FDA. It is also studying the injectable anti-inflammatory tocilizumab, the common blood thinner aspirin and colchicine, a widely used anti-inflammatory medicine.

Further results from the other arms of the trial are anticipated “over the next couple of months,” Horby said.

A separate late-stage trial of Novartis and Incyte’s chemotherapy drug, ruxolitinib — a Janus kinase (JAK) inhibitor — in 432 hospitalized Covid-19 patients also failed to show a benefit. The drug, in combination with standard of care, showed no statistically significant reduction in severe complications, including death, respiratory failure requiring ventilation or admission to intensive care by day 29, according to initial data. The regimen also didn’t show a clinically relevant benefit for reducing the mortality rate or time to recovery, the companies said.

“While the trial did not give us the results we hoped for, we will continue working with the medical community to analyze its findings to better understand COVID-19 and the role of JAK inhibition,” said John Tsai, Novartis’ chief medical officer and head of global drug development. — James Miessler