Treating Covid-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind, Randomized Controlled Trial in Hospitalized Patients

DOI record: { "DOI": "10.1093/ofid/ofaa446", "ISSN": [ "2328-8957" ], "URL": "http://dx.doi.org/10.1093/ofid/ofaa446", "abstract": "<jats:title>Abstract</jats:title>\n <jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>Effective 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.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusions</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec>", "author": [ { "ORCID": "http://orcid.org/0000-0002-3217-5062", "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA" } ], "authenticated-orcid": false, "family": "Ulrich", "given": "Robert J", "sequence": "first" }, { "affiliation": [ { "name": "Department of Population Health, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Biostatistics, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Troxel", "given": "Andrea B", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Carmody", "given": "Ellie", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Eapen", "given": "Jaishvi", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, Division of Infectious Diseases, NYU Long Island School of Medicine, Mineola, New York, USA" } ], "family": "Bäcker", "given": "Martin", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, Division of Infectious Diseases, State University of New York Downstate Health Sciences University, Brooklyn, New York, USA" } ], "family": "DeHovitz", "given": "Jack A", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Prasad", "given": "Prithiv J", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Population Health, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Biostatistics, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Li", "given": "Yi", "sequence": "additional" }, { "affiliation": [ { "name": "New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Delgado", "given": "Camila", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Jrada", "given": "Morris", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Pediatrics, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Pediatric Hematology-Oncology, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Robbins", "given": "Gabriel A", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Henderson", "given": "Brooklyn", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Hrycko", "given": "Alexander", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, Division of Infectious Diseases, NYU Long Island School of Medicine, Mineola, New York, USA" } ], "family": "Delpachitra", "given": "Dinuli", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0003-2579-1104", "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Department of Pediatrics, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Divison of Pediatric Infectious Diseases, New York University Grossman School of Medicine, New York, New York, USA" } ], "authenticated-orcid": false, "family": "Raabe", "given": "Vanessa", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Austrian", "given": "Jonathan S", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Department of Pharmacy, NYU Langone Health, New York, New York, USA" } ], "family": "Dubrovskaya", "given": "Yanina", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA" }, { "name": "Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA" } ], "family": "Mulligan", "given": "Mark J", "sequence": "additional" } ], 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Randomized Controlled Trial in Hospitalized Patients", "type": "journal-article", "volume": "7" }