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).
Identifieur interne : 000738 ( Main/Corpus ); précédent : 000737; suivant : 000739A 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).
Auteurs : Cheng-Pin Chen ; Yi-Chun Lin ; Tsung-Chia Chen ; Ting-Yu Tseng ; Hon-Lai Wong ; Cheng-Yu Kuo ; Wu-Pu Lin ; Sz-Rung Huang ; Wei-Yao Wang ; Jia-Hung Liao ; Chung-Shin Liao ; Yuan-Pin Hung ; Tse-Hung Lin ; Tz-Yan Chang ; Chin-Fu Hsiao ; Yi-Wen Huang ; Wei-Sheng Chung ; Chien-Yu Cheng ; Shu-Hsing ChengSource :
- PloS one [ 1932-6203 ] ; 2020.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Hydroxychloroquine.
- drug therapy : COVID-19.
- chemical , therapeutic use : Hydroxychloroquine.
- Adult, Female, Humans, Male, Middle Aged, Retrospective Studies, Safety, Standard of Care, Treatment Outcome, Young Adult.
Abstract
OBJECTIVE
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.
METHODS
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.
RESULTS
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 (p = 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 (p = 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 (p = 0.70).
CONCLUSIONS
Neither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.
DOI: 10.1371/journal.pone.0242763
PubMed: 33264337
PubMed Central: PMC7710068
Links to Exploration step
pubmed:33264337Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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).</title><author><name sortKey="Chen, Cheng Pin" sort="Chen, Cheng Pin" uniqKey="Chen C" first="Cheng-Pin" last="Chen">Cheng-Pin Chen</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Yi Chun" sort="Lin, Yi Chun" uniqKey="Lin Y" first="Yi-Chun" last="Lin">Yi-Chun Lin</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Graduate Institute of Clinical Medicine, Taipei Medical University, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Tsung Chia" sort="Chen, Tsung Chia" uniqKey="Chen T" first="Tsung-Chia" last="Chen">Tsung-Chia Chen</name><affiliation><nlm:affiliation>Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Tseng, Ting Yu" sort="Tseng, Ting Yu" uniqKey="Tseng T" first="Ting-Yu" last="Tseng">Ting-Yu Tseng</name><affiliation><nlm:affiliation>Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Wong, Hon Lai" sort="Wong, Hon Lai" uniqKey="Wong H" first="Hon-Lai" last="Wong">Hon-Lai Wong</name><affiliation><nlm:affiliation>Department of Internal Medicine, Keelung Hospital, Ministry of Health and Welfare, Keelung City, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Kuo, Cheng Yu" sort="Kuo, Cheng Yu" uniqKey="Kuo C" first="Cheng-Yu" last="Kuo">Cheng-Yu Kuo</name><affiliation><nlm:affiliation>Department of Internal Medicine, Pingtung Hospital, Ministry of Health and Welfare, Pingtung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Wu Pu" sort="Lin, Wu Pu" uniqKey="Lin W" first="Wu-Pu" last="Lin">Wu-Pu Lin</name><affiliation><nlm:affiliation>Department of Internal Medicine, Taipei Hospital, Ministry of Health and Welfare, New Taipei City, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Sz Rung" sort="Huang, Sz Rung" uniqKey="Huang S" first="Sz-Rung" last="Huang">Sz-Rung Huang</name><affiliation><nlm:affiliation>Department of Internal Medicine, Miaoli General Hospital, Ministry of Health and Welfare, Miaoli, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Wei Yao" sort="Wang, Wei Yao" uniqKey="Wang W" first="Wei-Yao" last="Wang">Wei-Yao Wang</name><affiliation><nlm:affiliation>Department of Internal Medicine, Feng Yuan Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Liao, Jia Hung" sort="Liao, Jia Hung" uniqKey="Liao J" first="Jia-Hung" last="Liao">Jia-Hung Liao</name><affiliation><nlm:affiliation>Department of Internal Medicine, Nantou Hospital, Ministry of Health and Welfare, Nantou, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Liao, Chung Shin" sort="Liao, Chung Shin" uniqKey="Liao C" first="Chung-Shin" last="Liao">Chung-Shin Liao</name><affiliation><nlm:affiliation>Department of Internal Medicine, Chia Yi Hospital, Ministry of Health and Welfare, Chiayi, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Hung, Yuan Pin" sort="Hung, Yuan Pin" uniqKey="Hung Y" first="Yuan-Pin" last="Hung">Yuan-Pin Hung</name><affiliation><nlm:affiliation>Department of Internal Medicine, Tainan Hospital, Ministry of Health and Welfare, Tainan City, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Tse Hung" sort="Lin, Tse Hung" uniqKey="Lin T" first="Tse-Hung" last="Lin">Tse-Hung Lin</name><affiliation><nlm:affiliation>Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Chang, Tz Yan" sort="Chang, Tz Yan" uniqKey="Chang T" first="Tz-Yan" last="Chang">Tz-Yan Chang</name><affiliation><nlm:affiliation>Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Hsiao, Chin Fu" sort="Hsiao, Chin Fu" uniqKey="Hsiao C" first="Chin-Fu" last="Hsiao">Chin-Fu Hsiao</name><affiliation><nlm:affiliation>Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Yi Wen" sort="Huang, Yi Wen" uniqKey="Huang Y" first="Yi-Wen" last="Huang">Yi-Wen Huang</name><affiliation><nlm:affiliation>Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Chung, Wei Sheng" sort="Chung, Wei Sheng" uniqKey="Chung W" first="Wei-Sheng" last="Chung">Wei-Sheng Chung</name><affiliation><nlm:affiliation>Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Health Service Administration, China Medical University, Taichung, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Healthcare Administration, Central Taiwan University of Science and Technology, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Cheng, Chien Yu" sort="Cheng, Chien Yu" uniqKey="Cheng C" first="Chien-Yu" last="Cheng">Chien-Yu Cheng</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>School of Public Health, National Yang-Ming University, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Cheng, Shu Hsing" sort="Cheng, Shu Hsing" uniqKey="Cheng S" first="Shu-Hsing" last="Cheng">Shu-Hsing Cheng</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>School of Public Health, Taipei Medical University, Taipei, Taiwan.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:33264337</idno><idno type="pmid">33264337</idno><idno type="doi">10.1371/journal.pone.0242763</idno><idno type="pmc">PMC7710068</idno><idno type="wicri:Area/Main/Corpus">000738</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000738</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">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).</title><author><name sortKey="Chen, Cheng Pin" sort="Chen, Cheng Pin" uniqKey="Chen C" first="Cheng-Pin" last="Chen">Cheng-Pin Chen</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Yi Chun" sort="Lin, Yi Chun" uniqKey="Lin Y" first="Yi-Chun" last="Lin">Yi-Chun Lin</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Graduate Institute of Clinical Medicine, Taipei Medical University, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Tsung Chia" sort="Chen, Tsung Chia" uniqKey="Chen T" first="Tsung-Chia" last="Chen">Tsung-Chia Chen</name><affiliation><nlm:affiliation>Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Tseng, Ting Yu" sort="Tseng, Ting Yu" uniqKey="Tseng T" first="Ting-Yu" last="Tseng">Ting-Yu Tseng</name><affiliation><nlm:affiliation>Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Wong, Hon Lai" sort="Wong, Hon Lai" uniqKey="Wong H" first="Hon-Lai" last="Wong">Hon-Lai Wong</name><affiliation><nlm:affiliation>Department of Internal Medicine, Keelung Hospital, Ministry of Health and Welfare, Keelung City, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Kuo, Cheng Yu" sort="Kuo, Cheng Yu" uniqKey="Kuo C" first="Cheng-Yu" last="Kuo">Cheng-Yu Kuo</name><affiliation><nlm:affiliation>Department of Internal Medicine, Pingtung Hospital, Ministry of Health and Welfare, Pingtung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Wu Pu" sort="Lin, Wu Pu" uniqKey="Lin W" first="Wu-Pu" last="Lin">Wu-Pu Lin</name><affiliation><nlm:affiliation>Department of Internal Medicine, Taipei Hospital, Ministry of Health and Welfare, New Taipei City, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Sz Rung" sort="Huang, Sz Rung" uniqKey="Huang S" first="Sz-Rung" last="Huang">Sz-Rung Huang</name><affiliation><nlm:affiliation>Department of Internal Medicine, Miaoli General Hospital, Ministry of Health and Welfare, Miaoli, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Wei Yao" sort="Wang, Wei Yao" uniqKey="Wang W" first="Wei-Yao" last="Wang">Wei-Yao Wang</name><affiliation><nlm:affiliation>Department of Internal Medicine, Feng Yuan Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Liao, Jia Hung" sort="Liao, Jia Hung" uniqKey="Liao J" first="Jia-Hung" last="Liao">Jia-Hung Liao</name><affiliation><nlm:affiliation>Department of Internal Medicine, Nantou Hospital, Ministry of Health and Welfare, Nantou, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Liao, Chung Shin" sort="Liao, Chung Shin" uniqKey="Liao C" first="Chung-Shin" last="Liao">Chung-Shin Liao</name><affiliation><nlm:affiliation>Department of Internal Medicine, Chia Yi Hospital, Ministry of Health and Welfare, Chiayi, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Hung, Yuan Pin" sort="Hung, Yuan Pin" uniqKey="Hung Y" first="Yuan-Pin" last="Hung">Yuan-Pin Hung</name><affiliation><nlm:affiliation>Department of Internal Medicine, Tainan Hospital, Ministry of Health and Welfare, Tainan City, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Tse Hung" sort="Lin, Tse Hung" uniqKey="Lin T" first="Tse-Hung" last="Lin">Tse-Hung Lin</name><affiliation><nlm:affiliation>Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Chang, Tz Yan" sort="Chang, Tz Yan" uniqKey="Chang T" first="Tz-Yan" last="Chang">Tz-Yan Chang</name><affiliation><nlm:affiliation>Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Hsiao, Chin Fu" sort="Hsiao, Chin Fu" uniqKey="Hsiao C" first="Chin-Fu" last="Hsiao">Chin-Fu Hsiao</name><affiliation><nlm:affiliation>Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Yi Wen" sort="Huang, Yi Wen" uniqKey="Huang Y" first="Yi-Wen" last="Huang">Yi-Wen Huang</name><affiliation><nlm:affiliation>Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Chung, Wei Sheng" sort="Chung, Wei Sheng" uniqKey="Chung W" first="Wei-Sheng" last="Chung">Wei-Sheng Chung</name><affiliation><nlm:affiliation>Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Health Service Administration, China Medical University, Taichung, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Healthcare Administration, Central Taiwan University of Science and Technology, Taichung, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Cheng, Chien Yu" sort="Cheng, Chien Yu" uniqKey="Cheng C" first="Chien-Yu" last="Cheng">Chien-Yu Cheng</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>School of Public Health, National Yang-Ming University, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Cheng, Shu Hsing" sort="Cheng, Shu Hsing" uniqKey="Cheng S" first="Shu-Hsing" last="Cheng">Shu-Hsing Cheng</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>School of Public Health, Taipei Medical University, Taipei, Taiwan.</nlm:affiliation></affiliation></author></analytic><series><title level="j">PloS one</title><idno type="eISSN">1932-6203</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term><term>COVID-19 (drug therapy)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (adverse effects)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Retrospective Studies (MeSH)</term><term>Safety (MeSH)</term><term>Standard of Care (MeSH)</term><term>Treatment Outcome (MeSH)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Retrospective Studies</term><term>Safety</term><term>Standard of Care</term><term>Treatment Outcome</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><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.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><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.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><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 (p = 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 (p = 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 (p = 0.70).</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Neither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33264337</PMID><DateCompleted><Year>2020</Year><Month>12</Month><Day>11</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>14</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">1932-6203</ISSN><JournalIssue CitedMedium="Internet"><Volume>15</Volume><Issue>12</Issue><PubDate><Year>2020</Year></PubDate></JournalIssue><Title>PloS one</Title><ISOAbbreviation>PLoS One</ISOAbbreviation></Journal><ArticleTitle>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).</ArticleTitle><Pagination><MedlinePgn>e0242763</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1371/journal.pone.0242763</ELocationID><Abstract><AbstractText Label="OBJECTIVE">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.</AbstractText><AbstractText Label="METHODS">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.</AbstractText><AbstractText Label="RESULTS">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 (p = 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 (p = 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 (p = 0.70).</AbstractText><AbstractText Label="CONCLUSIONS">Neither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Cheng-Pin</ForeName><Initials>CP</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lin</LastName><ForeName>Yi-Chun</ForeName><Initials>YC</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Graduate Institute of Clinical Medicine, Taipei Medical University, Taipei, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Tsung-Chia</ForeName><Initials>TC</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tseng</LastName><ForeName>Ting-Yu</ForeName><Initials>TY</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wong</LastName><ForeName>Hon-Lai</ForeName><Initials>HL</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Keelung Hospital, Ministry of Health and Welfare, Keelung City, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kuo</LastName><ForeName>Cheng-Yu</ForeName><Initials>CY</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Pingtung Hospital, Ministry of Health and Welfare, Pingtung, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lin</LastName><ForeName>Wu-Pu</ForeName><Initials>WP</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Taipei Hospital, Ministry of Health and Welfare, New Taipei City, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huang</LastName><ForeName>Sz-Rung</ForeName><Initials>SR</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Miaoli General Hospital, Ministry of Health and Welfare, Miaoli, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Wei-Yao</ForeName><Initials>WY</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Feng Yuan Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liao</LastName><ForeName>Jia-Hung</ForeName><Initials>JH</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Nantou Hospital, Ministry of Health and Welfare, Nantou, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liao</LastName><ForeName>Chung-Shin</ForeName><Initials>CS</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Chia Yi Hospital, Ministry of Health and Welfare, Chiayi, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hung</LastName><ForeName>Yuan-Pin</ForeName><Initials>YP</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Tainan Hospital, Ministry of Health and Welfare, Tainan City, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lin</LastName><ForeName>Tse-Hung</ForeName><Initials>TH</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chang</LastName><ForeName>Tz-Yan</ForeName><Initials>TY</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hsiao</LastName><ForeName>Chin-Fu</ForeName><Initials>CF</Initials><AffiliationInfo><Affiliation>Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huang</LastName><ForeName>Yi-Wen</ForeName><Initials>YW</Initials><Identifier Source="ORCID">0000-0001-6097-3910</Identifier><AffiliationInfo><Affiliation>Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chung</LastName><ForeName>Wei-Sheng</ForeName><Initials>WS</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Health Service Administration, China Medical University, Taichung, Taiwan.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Healthcare Administration, Central Taiwan University of Science and Technology, Taichung, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cheng</LastName><ForeName>Chien-Yu</ForeName><Initials>CY</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>School of Public Health, National Yang-Ming University, Taipei, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cheng</LastName><ForeName>Shu-Hsing</ForeName><Initials>SH</Initials><Identifier Source="ORCID">0000-0002-6256-0527</Identifier><AffiliationInfo><Affiliation>Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>School of Public Health, Taipei Medical University, Taipei, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>Taiwan HCQ Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter 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UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012189" MajorTopicYN="N">Retrospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012449" MajorTopicYN="Y">Safety</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D059039" MajorTopicYN="N">Standard of Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment 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