• Robert J Ulrich, Andrea B Troxel, Ellie Carmody, Jaishvi Eapen, Martin Bäcker, Jack A DeHovitz, Prithiv J Prasad, Yi Li, Camila Delgado, Morris Jrada, Gabriel A Robbins, Brooklyn Henderson, Alexander Hrycko, Dinuli Delpachitra, Vanessa Raabe, Jonathan S Austrian, Yanina Dubrovskaya, and Mark J Mulligan.
• Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.
• Open Forum Infect Dis. 2020 Oct 1; 7 (10): ofaa446.

BackgroundEffective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19.MethodsWe conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14.ResultsA total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance (P = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay.ConclusionsIn hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

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