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Hydroxychloroquine in treatment of outpatients with mildly symptomatic COVID-19

August 28, 2020

View ORCID ProfileAndrew Ip, View ORCID ProfileJaeil Ahn, Yizhao Zhou, View ORCID ProfileAndre H Goy, Eric Hansen, View ORCID ProfileAndrew L Pecora, Brittany A Sinclaire, Urszula Bednarz, Michael Marafelias, Shivam Mathura, Ihor S Sawczuk, View ORCID ProfileJoseph P Underwood III, David M Walker, Rajiv Prasad, Robert L Sweeney, Marie G Ponce, Samuel LaCapra, Frank J Cunningham, Arthur G Calise, Bradley L Pulver, Dominic Ruocco, Greggory E Mojares, Michael P Eagan, Kristy L Ziontz, Paul Mastrokyriakos, View ORCID ProfileStuart L Goldberg

doi: https://doi.org/10.1101/2020.08.20.20178772

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2020.08.20.20178772v1.full.pdf

Abstract

Background: Hydroxychloroquine has not been associated with improved survival among hospitalized COVID-19 patients in the majority of observational studies and similarly was not identified as an effective prophylaxis following exposure in a prospective randomized trial. We aimed to explore the role of hydroxychloroquine therapy in mildly symptomatic patients diagnosed in the outpatient setting. Methods: We examined the association between outpatient hydroxychloroquine exposure and the subsequent progression of disease among mildly symptomatic non-hospitalized patients with documented SARS-CoV-2 infection. The primary outcome assessed was requirement of hospitalization. Data was obtained from a retrospective review of electronic health records within a New Jersey USA multi-hospital network. We compared outcomes in patients who received hydroxychloroquine with those who did not applying a multivariable logistic model with propensity matching. Results: Among 1274 outpatients with documented SARS-CoV-2 infection 7.6% were prescribed hydroxychloroquine. In a 1067 patient propensity matched cohort, 21.6% with outpatient exposure to hydroxychloroquine were hospitalized, and 31.4% without exposure were hospitalized. In the primary multivariable logistic regression analysis with propensity matching there was an association between exposure to hydroxychloroquine and a decreased rate of hospitalization from COVID-19 (OR 0.53; 95% CI, 0.29, 0.95). Sensitivity analyses revealed similar associations. QTc prolongation events occurred in 2% of patients prescribed hydroxychloroquine with no reported arrhythmia events among those with data available. Conclusions: In this retrospective observational study of SARS-CoV-2 infected non-hospitalized patients hydroxychloroquine exposure was associated with a decreased rate of subsequent hospitalization. Additional exploration of hydroxychloroquine in this mildly symptomatic outpatient population is warranted.

Competing Interest Statement

All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; AHG reports being a study investigator for Genentech-Hoffman La Roche, during the conduct of the study; research funding as study investigator from Acerta, AstraZeneca, Celgene, Kite Pharma, Elsevier’s PracticeUpdate Oncology, Gilead, Medscape, MJH Associates, OncLive Peer Exchange, Physicians Education Resource, and Xcenda, outside the submitted work, and research funding as a study investigator for Constellation, Infinity, Infinity Verastem, Janssen, Karyopharm, and Pharmacyclics, outside of the submitted work. EH and SM report consulting for Regional Cancer Care Associates and Hackensack Meridian Health, outside the submitted work. ALP and SLG report having equity ownership in COTA, outside the submitted work. No other relationships or activities that could appear to have influenced the submitted work.

Clinical Trial

NCT04347993

Funding Statement

No external funding was received to support this research.

https://www.medrxiv.org/content/10.1101/2020.08.20.20178772v1

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