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

{ 'indexed': {'date-parts': [[2024, 3, 13]], 'date-time': '2024-03-13T06:50:09Z', 'timestamp': 1710312609724}, 'reference-count': 40, 'publisher': 'Oxford University Press (OUP)', 'issue': '10', 'license': [ { 'start': { 'date-parts': [[2020, 9, 23]], 'date-time': '2020-09-23T00:00:00Z', 'timestamp': 1600819200000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'http://creativecommons.org/licenses/by-nc-nd/4.0/'}], 'funder': [ {'name': 'New York University Grossman School of Medicine'}, {'name': 'NYU CTSA', 'award': ['TL1 TR001445', 'UL1 TR001445']}, { 'DOI': '10.13039/100006108', 'name': 'National Center for Advancing Translational Sciences', 'doi-asserted-by': 'publisher'}, {'name': 'New York State Empire Clinical Research Investigator Program'}, { 'DOI': '10.13039/100000060', 'name': 'National Institute of Allergy and Infectious Diseases', 'doi-asserted-by': 'publisher'}, { 'DOI': '10.13039/100000002', 'name': 'National Institutes of Health', 'doi-asserted-by': 'publisher', 'award': ['UM1 AI148574']}, { 'name': 'National Institutes of Health Fogarty', 'award': ['D43 TW010046', 'D43 TW010562', 'D43 TW011532']}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'published-print': {'date-parts': [[2020, 10, 1]]}, '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\u2005=\u200567) and placebo (n\u2005=\u200561) 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\u2005=\u2005' '.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>', 'DOI': '10.1093/ofid/ofaa446', 'type': 'journal-article', 'created': {'date-parts': [[2020, 9, 23]], 'date-time': '2020-09-23T05:34:34Z', 'timestamp': 1600839274000}, 'source': 'Crossref', 'is-referenced-by-count': 47, 'title': 'Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized ' 'Controlled Trial in Hospitalized Patients', 'prefix': '10.1093', 'volume': '7', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-3217-5062', 'authenticated-orcid': False, 'given': 'Robert J', 'family': 'Ulrich', 'sequence': 'first', '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'}]}, { 'given': 'Andrea B', 'family': 'Troxel', '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'}]}, { 'given': 'Ellie', 'family': 'Carmody', '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'}]}, { 'given': 'Jaishvi', 'family': 'Eapen', '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'}]}, { 'given': 'Martin', 'family': 'Bäcker', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Medicine, Division of Infectious Diseases, NYU ' 'Long Island School of Medicine, Mineola, New York, USA'}]}, { 'given': 'Jack A', 'family': 'DeHovitz', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Medicine, Division of Infectious Diseases, State ' 'University of New York Downstate Health Sciences University, ' 'Brooklyn, New York, USA'}]}, { 'given': 'Prithiv J', 'family': 'Prasad', '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'}]}, { 'given': 'Yi', 'family': 'Li', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Population Health, New York University Grossman ' 'School 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