A Multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate Coronavirus disease 2019 (COVID-19)

{ 'indexed': {'date-parts': [[2024, 3, 3]], 'date-time': '2024-03-03T01:54:12Z', 'timestamp': 1709430852425}, 'reference-count': 35, 'publisher': 'Public Library of Science (PLoS)', 'issue': '12', 'license': [ { 'start': { 'date-parts': [[2020, 12, 2]], 'date-time': '2020-12-02T00:00:00Z', 'timestamp': 1606867200000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'http://creativecommons.org/licenses/by/4.0/'}], 'funder': [ { 'DOI': '10.13039/100008903', 'name': 'Ministry of Health and Welfare', 'doi-asserted-by': 'publisher'}], 'content-domain': {'domain': ['www.plosone.org'], 'crossmark-restriction': False}, 'abstract': '<jats:sec id="sec001">\n' '<jats:title>Objective</jats:title>\n' '<jats:p>In this study, we evaluated the efficacy of hydroxychloroquine (HCQ) against ' 'coronavirus disease 2019 (COVID-19) via a randomized controlled trial (RCT) and a ' 'retrospective study.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec002">\n' '<jats:title>Methods</jats:title>\n' '<jats:p>Subjects admitted to 11 designated public hospitals in Taiwan between April 1 and May ' '31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, ' 'were randomized at a 2:1 ratio and stratified by mild or moderate illness. HCQ (400 mg twice ' 'for 1 d or HCQ 200 mg twice daily for 6 days) was administered. Both the study and control ' 'group received standard of care (SOC). Pharyngeal swabs and sputum were collected every other ' 'day. The proportion and time to negative viral PCR were assessed on day 14. In the ' 'retrospective study, medical records were reviewed for patients admitted before March 31, ' '2020.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec003">\n' '<jats:title>Results</jats:title>\n' '<jats:p>There were 33 and 37 cases in the RCT and retrospective study, respectively. In the ' 'RCT, the median times to negative rRT-PCR from randomization to hospital day 14 were 5 days ' '(95% CI; 1, 9 days) and 10 days (95% CI; 2, 12 days) for the HCQ and SOC groups, respectively ' '(<jats:italic>p</jats:italic> = 0.40). On day 14, 81.0% (17/21) and 75.0% (9/12) of the ' 'subjects in the HCQ and SOC groups, respectively, had undetected virus ' '(<jats:italic>p</jats:italic> = 0.36). In the retrospective study, 12 (42.9%) in the HCQ ' 'group and 5 (55.6%) in the control group had negative rRT-PCR results on hospital day 14 ' '(<jats:italic>p</jats:italic> = 0.70).</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec004">\n' '<jats:title>Conclusions</jats:title>\n' '<jats:p>Neither study demonstrated that HCQ shortened viral shedding in mild to moderate ' 'COVID-19 subjects.</jats:p>\n' '</jats:sec>', 'DOI': '10.1371/journal.pone.0242763', 'type': 'journal-article', 'created': {'date-parts': [[2020, 12, 2]], 'date-time': '2020-12-02T19:19:35Z', 'timestamp': 1606936775000}, 'page': 'e0242763', 'update-policy': 'http://dx.doi.org/10.1371/journal.pone.corrections_policy', 'source': 'Crossref', 'is-referenced-by-count': 35, 'title': 'A multicenter, randomized, open-label, controlled trial to evaluate the efficacy and ' 'tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to ' 'moderate coronavirus disease 2019 (COVID-19)', 'prefix': '10.1371', 'volume': '15', 'author': [ {'given': 'Cheng-Pin', 'family': 'Chen', 'sequence': 'first', 'affiliation': []}, {'given': 'Yi-Chun', 'family': 'Lin', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tsung-Chia', 'family': 'Chen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ting-Yu', 'family': 'Tseng', 'sequence': 'additional', 'affiliation': []}, {'given': 'Hon-Lai', 'family': 'Wong', 'sequence': 'additional', 'affiliation': []}, {'given': 'Cheng-Yu', 'family': 'Kuo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Wu-Pu', 'family': 'Lin', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sz-Rung', 'family': 'Huang', 'sequence': 'additional', 'affiliation': []}, {'given': 'Wei-Yao', 'family': 'Wang', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jia-Hung', 'family': 'Liao', 'sequence': 'additional', 'affiliation': []}, {'given': 'Chung-Shin', 'family': 'Liao', 'sequence': 'additional', 'affiliation': []}, {'given': 'Yuan-Pin', 'family': 'Hung', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tse-Hung', 'family': 'Lin', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tz-Yan', 'family': 'Chang', 'sequence': 'additional', 'affiliation': []}, {'given': 'Chin-Fu', 'family': 'Hsiao', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-6097-3910', 'authenticated-orcid': True, 'given': 'Yi-Wen', 'family': 'Huang', 'sequence': 'additional', 'affiliation': []}, {'given': 'Wei-Sheng', 'family': 'Chung', 'sequence': 'additional', 'affiliation': []}, {'given': 'Chien-Yu', 'family': 'Cheng', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-6256-0527', 'authenticated-orcid': True, 'given': 'Shu-Hsing', 'family': 'Cheng', 'sequence': 'additional', 'affiliation': []}, { 'name': 'on behalf of the Taiwan HCQ Study Group', 'sequence': 'additional', 'affiliation': []}], 'member': '340', 'published-online': {'date-parts': [[2020, 12, 2]]}, 'reference': [ { 'key': 'pone.0242763.ref001', 'unstructured': 'World Health Organization. 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