期刊
OPEN FORUM INFECTIOUS DISEASES
卷 7, 期 10, 页码 -出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/ofid/ofaa446
关键词
COVID-19; hydroxychloroquine; randomized controlled trial; SARS-CoV-2
资金
- New York University Grossman School of Medicine
- NYU CTSA grant from the National Center for Advancing Translational Sciences (NCATS) [UL1 TR001445]
- New York State Empire Clinical Research Investigator Program (ECRIP)
- National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) [UM1 AI148574]
- National Institutes of Health Fogarty grants [D43 TW010046, D43 TW010562, D43 TW011532]
- NYU CTSA grant from the National Center for Advancing Translational Sciences, National Institutes of Health [UL1 TR001445]
Background. Effective therapies to combat coronavirus 2019 (COVID-19) arc 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. Methods. We 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. Results. A 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. Conclusions. In 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.
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