New York Study Shows Treatment with Hydroxychloroquine, Azithromycin, or Both, Did Not Significantly Improve Mortality Among Seriously Ill COVID-19 Patient

Brooklyn, N.Y. (May 13, 2020) - Results of an observational study of the use hydroxychloroquine, azithromycin, or both, for the treatment of COVID-19, was not associated with significantly improved in-hospital mortality. The study was published online on Monday, May 11, by the Journal of the American Medical Association.

"Unfortunately, we did not observe benefits of the most used drug (hydroxychloroquine with or without azithromycin) in this group of seriously ill patients,” said study co-investigator Jack DeHovitz, M.D, MPH, MHCDS, FACP, Distinguished Service Professor at SUNY Downstate and Director of the STAR Program. “A randomized controlled trial is the best way to determine if a drug has a benefit, and the investigators support enrolling patients with COVID-19 into these trials.  Such studies of hydroxychloroquine are already enrolling in the United States, including one at SUNY Downstate Health Sciences University."

The study also found that hydroxychloroquine taken in conjunction with azithromycin (compared to neither drug) was associated with significantly elevated levels of cardiac arrest, even after statistical adjustment for sex, age, underlying health conditions, and more severe illness upon admission.

The findings of observational studies should be considered by physicians and patients in concert with findings from randomized controlled trials, other empirical studies, NIH treatment guidelines and FDA drug safety communications. 

The study does not involve randomization of treatment, but rather is an observational cohort study of medical records for hospitalized patients with a COVID-19 diagnosis. Medical records were reviewed for a sample of 1438 patients from 25 hospitals in the greater New York City region. All patients had a hospital admission dates between March 15 and March 28, 2020. In all, 735 patients received hydroxychloroquine with azithromycin, 271 hydroxychloroquine alone, 211 azithromycin alone, and 221 received neither drug. Patients were more likely to receive the medications if they had underlying risk factors for severe illness or more severe illness at presentation. According to investigators, additional analysis is needed to determine if whether the patients’ course of clinical progression was due to more severe illness upon hospitalization or administered drugs.