Findings Released from Observational Study of Hydroxychloroquine and Azithromycin on Patients with COVID-19 in New York State

The School of Public Health and Department of Health, for their study, reviewed 1,438 patients from 25 hospitals in the greater New York City region.

ALBANY, N.Y. (May 15, 2020) – Results from an observational study of hydroxychloroquine and azithromycin have been released from the University at Albany and the New York State Department of Health (NYSDOH); the findings were published today in the Journal of the American Medical Association (JAMA).

The study aimed to answer three main questions:

1. To what degree are physicians prescribing hydroxychloroquine, azithromycin, and/or chloroquine for COVID-19 hospitalized patients?
2. To what degree are there adverse effects of these drugs when prescribed?
3. To what extent do these drugs improve patient clinical outcomes?

The study does not involve  randomization of treatments 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.

Analysis of the records reviewed indicate the following:

1. Hydroxychloroquine and azithromycin  (sometimes in combination) were being utilized during this timeframe by  healthcare providers in their treatment of ill patients hospitalized with  COVID-19 (735 patients received hydroxychloroquine with azithromycin, 271  hydroxychloroquine alone, 211 azithromycin alone, and 221 received neither  drug);
    
2. Chloroquine prescribing was so limited  in use (less than 2% of the first several hundred records screened) that it was  dropped from further analysis;
    
3. Patients are more likely to receive  the medications if they had underlying risk factors for severe illness or more  severe illness at presentation (making it vital in statistical analyses to attempt  to determine if the patients’ course of clinical progression was due to more  severe illness upon hospitalization or administered drugs);
    
4. Everyone had hoped for a large and  immediate beneficial impact of these therapies, but for this group of seriously  ill patients, we did not observe a significant benefit of the administered  drugs;
    
5. 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.

These data and analyses are  not meant as a clinical recommendation. 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 Dean of the School of Public  Health at University at Albany, David Holtgrave, notes that “the fast moving public health implications of the COVID-19 pandemic necessitates that we  examine potential treatments for the disease in the most rapid yet careful  manner possible. This observational study has given us an important early look  at some key questions related to prescribing patterns of hydroxychloroquine,  azithromycin and chloroquine. Unfortunately, we did not observe benefits of the  most used drug (hydroxychloroquine with or without azithromycin) in this group  of seriously ill, hospitalized patients.”

For 35 years,  UAlbany’s School of Public Health has partnered with NYSDOH on a variety of  initiatives, and assisting the Department with the response for a health crisis  of the magnitude of the COVID-19 pandemic is a natural fit. Additionally, a co-author of this study is from Downstate Health Sciences  University.
 

Details on the full study are  available at the JAMA website.

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