Azithromycin versus standard care in patients with mild-to-moderate COVID-19, did not reduce the risk of hospital admission or mortality.
During the height of the pandemic, hospitalists were scrambling to find therapies to help their patients. Clinicians began administering a variety of medications to see if anything was efficacious against the virus.
One combination therapy, hydroxychloroquine and azithromycin, offered some excitement initially with some small studies. During this period, the media reported for several weeks of this combination. As such, investigators wanted to see if there was any benefits in bigger and longer studies in either the same combination or as standalone therapy regimens.
The ATOMIC2 trial was one standalone study conducted in the United Kingdom that examined the benefits of azithromycin versus standard care in patients with mild-to-moderate COVID-19 to see if it reduced hospital admission or mortality. This was a prospective, open-label, randomized superiority trial done at 19 hospitals in the UK.
The findings were published in The Lancet Respiratory Medicine, and presented at the European Congress of Clinical Microbiology and Infectious Diseases Conference.
“In patients with mild-to-moderate COVID-19 managed without hospital admission, adding azithromycin to standard care treatment did not reduce the risk of subsequent hospital admission or death,” the investigators wrote. “Our findings do not support the use of azithromycin in patients with mild-to-moderate COVID-19.”
For the trial, they enrolled adults at least 18 years old who presented to hospitals with with clinically diagnosed, highly probable, or confirmed COVID-19, and everyone had fewer than 14 days of symptoms. The participants were randomly assigned (1:1) to azithromycin (500 mg once daily orally for 14 days) plus standard care or to standard care alone. The primary study results came from 292 participants with 145 in the azithromycin cohort and 147 in the standard care cohort. There was a mean age of 45.9. The primary outcome was either death or hospital admission from any cause over the 28 days from randomization.
“Fifteen (10%) participants in the azithromycin group and 17 (12%) in the standard care group were admitted to hospital or died during the study (adjusted OR 0·91 [95% CI 0·43–1·92], p=0·80),” the investigators reported. And no serious adverse events were reported.
In conclusion, the investigators did not see a clinical benefit to administering azithromycin. “Our findings in mild-to-moderate COVID-19 managed in ambulatory care, taken together with trials in early disease in primary care and from trials in patients admitted to hospital with severe disease, suggest that azithromycin does not reduce hospital admissions, respiratory failure, or death compared with standard care, and should not be used in the treatment of COVID-19,” the investigators wrote.