Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.
Identifieur interne : 001691 ( Main/Corpus ); précédent : 001690; suivant : 001692Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.
Auteurs : Wei Tang ; Zhujun Cao ; Mingfeng Han ; Zhengyan Wang ; Junwen Chen ; Wenjin Sun ; Yaojie Wu ; Wei Xiao ; Shengyong Liu ; Erzhen Chen ; Wei Chen ; Xiongbiao Wang ; Jiuyong Yang ; Jun Lin ; Qingxia Zhao ; Youqin Yan ; Zhibin Xie ; Dan Li ; Yaofeng Yang ; Leshan Liu ; Jieming Qu ; Guang Ning ; Guochao Shi ; Qing XieSource :
- BMJ (Clinical research ed.) [ 1756-1833 ] ; 2020.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Antiviral Agents, Hydroxychloroquine.
- geographic : China.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- Adult, COVID-19, Female, Humans, Male, Middle Aged, Pandemics, Treatment Outcome.
Abstract
OBJECTIVE
To assess the efficacy and safety of hydroxychloroquine plus standard of care compared with standard of care alone in adults with coronavirus disease 2019 (covid-19).
DESIGN
Multicentre, open label, randomised controlled trial.
SETTING
16 government designated covid-19 treatment centres in China, 11 to 29 February 2020.
PARTICIPANTS
150 patients admitted to hospital with laboratory confirmed covid-19 were included in the intention to treat analysis (75 patients assigned to hydroxychloroquine plus standard of care, 75 to standard of care alone).
INTERVENTIONS
Hydroxychloroquine administrated at a loading dose of 1200 mg daily for three days followed by a maintenance dose of 800 mg daily (total treatment duration: two or three weeks for patients with mild to moderate or severe disease, respectively).
MAIN OUTCOME MEASURE
Negative conversion of severe acute respiratory syndrome coronavirus 2 by 28 days, analysed according to the intention to treat principle. Adverse events were analysed in the safety population in which hydroxychloroquine recipients were participants who received at least one dose of hydroxychloroquine and hydroxychloroquine non-recipients were those managed with standard of care alone.
RESULTS
Of 150 patients, 148 had mild to moderate disease and two had severe disease. The mean duration from symptom onset to randomisation was 16.6 (SD 10.5; range 3-41) days. A total of 109 (73%) patients (56 standard of care; 53 standard of care plus hydroxychloroquine) had negative conversion well before 28 days, and the remaining 41 (27%) patients (19 standard of care; 22 standard of care plus hydroxychloroquine) were censored as they did not reach negative conversion of virus. The probability of negative conversion by 28 days in the standard of care plus hydroxychloroquine group was 85.4% (95% confidence interval 73.8% to 93.8%), similar to that in the standard of care group (81.3%, 71.2% to 89.6%). The difference between groups was 4.1% (95% confidence interval -10.3% to 18.5%). In the safety population, adverse events were recorded in 7/80 (9%) hydroxychloroquine non-recipients and in 21/70 (30%) hydroxychloroquine recipients. The most common adverse event in the hydroxychloroquine recipients was diarrhoea, reported in 7/70 (10%) patients. Two hydroxychloroquine recipients reported serious adverse events.
CONCLUSIONS
Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19. Adverse events were higher in hydroxychloroquine recipients than in non-recipients.
TRIAL REGISTRATION
ChiCTR2000029868.
DOI: 10.1136/bmj.m1849
PubMed: 32409561
PubMed Central: PMC7221473
Links to Exploration step
pubmed:32409561Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.</title><author><name sortKey="Tang, Wei" sort="Tang, Wei" uniqKey="Tang W" first="Wei" last="Tang">Wei Tang</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Cao, Zhujun" sort="Cao, Zhujun" uniqKey="Cao Z" first="Zhujun" last="Cao">Zhujun Cao</name><affiliation><nlm:affiliation>Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.</nlm:affiliation></affiliation></author><author><name sortKey="Han, Mingfeng" sort="Han, Mingfeng" uniqKey="Han M" first="Mingfeng" last="Han">Mingfeng Han</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, No 2 People's Hospital of Fuyang City, Fuyang, Anhui, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Zhengyan" sort="Wang, Zhengyan" uniqKey="Wang Z" first="Zhengyan" last="Wang">Zhengyan Wang</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Suizhou Hospital, Hubei University of Medicine, Suizhou, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Junwen" sort="Chen, Junwen" uniqKey="Chen J" first="Junwen" last="Chen">Junwen Chen</name><affiliation><nlm:affiliation>Department of Respiratory and Critical Care Medicine, Xiangyang No 1 People's Hospital, Hubei University of Medicine, Xiangyang, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Sun, Wenjin" sort="Sun, Wenjin" uniqKey="Sun W" first="Wenjin" last="Sun">Wenjin Sun</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Central Hospital of Ezhou, Ezhou, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wu, Yaojie" sort="Wu, Yaojie" uniqKey="Wu Y" first="Yaojie" last="Wu">Yaojie Wu</name><affiliation><nlm:affiliation>Department of Cardiovascular Medicine, Yunmeng People's Hospital, Xiaogan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xiao, Wei" sort="Xiao, Wei" uniqKey="Xiao W" first="Wei" last="Xiao">Wei Xiao</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, First People's Hospital of Jingzhou City, Jingzhou, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Shengyong" sort="Liu, Shengyong" uniqKey="Liu S" first="Shengyong" last="Liu">Shengyong Liu</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Erzhen" sort="Chen, Erzhen" uniqKey="Chen E" first="Erzhen" last="Chen">Erzhen Chen</name><affiliation><nlm:affiliation>Department of Emergency Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Wei" sort="Chen, Wei" uniqKey="Chen W" first="Wei" last="Chen">Wei Chen</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Xiongbiao" sort="Wang, Xiongbiao" uniqKey="Wang X" first="Xiongbiao" last="Wang">Xiongbiao Wang</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yang, Jiuyong" sort="Yang, Jiuyong" uniqKey="Yang J" first="Jiuyong" last="Yang">Jiuyong Yang</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Hubei Space Hospital of Xiaogan, Xiaogan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Jun" sort="Lin, Jun" uniqKey="Lin J" first="Jun" last="Lin">Jun Lin</name><affiliation><nlm:affiliation>Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Zhao, Qingxia" sort="Zhao, Qingxia" uniqKey="Zhao Q" first="Qingxia" last="Zhao">Qingxia Zhao</name><affiliation><nlm:affiliation>Department of Infectious Disease, The Sixth People's Hospital of Zhengzhou, Zhengzhou, Henan, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yan, Youqin" sort="Yan, Youqin" uniqKey="Yan Y" first="Youqin" last="Yan">Youqin Yan</name><affiliation><nlm:affiliation>Department of Infectious Disease, Wuhan No 7 Hospital, Wuhan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xie, Zhibin" sort="Xie, Zhibin" uniqKey="Xie Z" first="Zhibin" last="Xie">Zhibin Xie</name><affiliation><nlm:affiliation>Departments of Respiratory Medicine, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China xieqingrjh@163.com.</nlm:affiliation></affiliation></author><author><name sortKey="Li, Dan" sort="Li, Dan" uniqKey="Li D" first="Dan" last="Li">Dan Li</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, The Third People's Hospital of Yichang, Yichang, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yang, Yaofeng" sort="Yang, Yaofeng" uniqKey="Yang Y" first="Yaofeng" last="Yang">Yaofeng Yang</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Xiao Gan First People's Hospital, Xiaogan, Hubei Province, China.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Leshan" sort="Liu, Leshan" uniqKey="Liu L" first="Leshan" last="Liu">Leshan Liu</name><affiliation><nlm:affiliation>Clinical Research Centre, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Qu, Jieming" sort="Qu, Jieming" uniqKey="Qu J" first="Jieming" last="Qu">Jieming Qu</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Ning, Guang" sort="Ning, Guang" uniqKey="Ning G" first="Guang" last="Ning">Guang Ning</name><affiliation><nlm:affiliation>Shanghai National Research Centre for Endocrine and Metabolic Diseases, State Key Laboratory of Medical Genomics, Shanghai Institute for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Shi, Guochao" sort="Shi, Guochao" uniqKey="Shi G" first="Guochao" last="Shi">Guochao Shi</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xie, Qing" sort="Xie, Qing" uniqKey="Xie Q" first="Qing" last="Xie">Qing Xie</name><affiliation><nlm:affiliation>Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China xieqingrjh@163.com.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32409561</idno><idno type="pmid">32409561</idno><idno type="doi">10.1136/bmj.m1849</idno><idno type="pmc">PMC7221473</idno><idno type="wicri:Area/Main/Corpus">001691</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001691</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.</title><author><name sortKey="Tang, Wei" sort="Tang, Wei" uniqKey="Tang W" first="Wei" last="Tang">Wei Tang</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Cao, Zhujun" sort="Cao, Zhujun" uniqKey="Cao Z" first="Zhujun" last="Cao">Zhujun Cao</name><affiliation><nlm:affiliation>Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.</nlm:affiliation></affiliation></author><author><name sortKey="Han, Mingfeng" sort="Han, Mingfeng" uniqKey="Han M" first="Mingfeng" last="Han">Mingfeng Han</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, No 2 People's Hospital of Fuyang City, Fuyang, Anhui, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Zhengyan" sort="Wang, Zhengyan" uniqKey="Wang Z" first="Zhengyan" last="Wang">Zhengyan Wang</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Suizhou Hospital, Hubei University of Medicine, Suizhou, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Junwen" sort="Chen, Junwen" uniqKey="Chen J" first="Junwen" last="Chen">Junwen Chen</name><affiliation><nlm:affiliation>Department of Respiratory and Critical Care Medicine, Xiangyang No 1 People's Hospital, Hubei University of Medicine, Xiangyang, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Sun, Wenjin" sort="Sun, Wenjin" uniqKey="Sun W" first="Wenjin" last="Sun">Wenjin Sun</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Central Hospital of Ezhou, Ezhou, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wu, Yaojie" sort="Wu, Yaojie" uniqKey="Wu Y" first="Yaojie" last="Wu">Yaojie Wu</name><affiliation><nlm:affiliation>Department of Cardiovascular Medicine, Yunmeng People's Hospital, Xiaogan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xiao, Wei" sort="Xiao, Wei" uniqKey="Xiao W" first="Wei" last="Xiao">Wei Xiao</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, First People's Hospital of Jingzhou City, Jingzhou, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Shengyong" sort="Liu, Shengyong" uniqKey="Liu S" first="Shengyong" last="Liu">Shengyong Liu</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Erzhen" sort="Chen, Erzhen" uniqKey="Chen E" first="Erzhen" last="Chen">Erzhen Chen</name><affiliation><nlm:affiliation>Department of Emergency Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Wei" sort="Chen, Wei" uniqKey="Chen W" first="Wei" last="Chen">Wei Chen</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Xiongbiao" sort="Wang, Xiongbiao" uniqKey="Wang X" first="Xiongbiao" last="Wang">Xiongbiao Wang</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yang, Jiuyong" sort="Yang, Jiuyong" uniqKey="Yang J" first="Jiuyong" last="Yang">Jiuyong Yang</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Hubei Space Hospital of Xiaogan, Xiaogan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Jun" sort="Lin, Jun" uniqKey="Lin J" first="Jun" last="Lin">Jun Lin</name><affiliation><nlm:affiliation>Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Zhao, Qingxia" sort="Zhao, Qingxia" uniqKey="Zhao Q" first="Qingxia" last="Zhao">Qingxia Zhao</name><affiliation><nlm:affiliation>Department of Infectious Disease, The Sixth People's Hospital of Zhengzhou, Zhengzhou, Henan, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yan, Youqin" sort="Yan, Youqin" uniqKey="Yan Y" first="Youqin" last="Yan">Youqin Yan</name><affiliation><nlm:affiliation>Department of Infectious Disease, Wuhan No 7 Hospital, Wuhan, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xie, Zhibin" sort="Xie, Zhibin" uniqKey="Xie Z" first="Zhibin" last="Xie">Zhibin Xie</name><affiliation><nlm:affiliation>Departments of Respiratory Medicine, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China xieqingrjh@163.com.</nlm:affiliation></affiliation></author><author><name sortKey="Li, Dan" sort="Li, Dan" uniqKey="Li D" first="Dan" last="Li">Dan Li</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, The Third People's Hospital of Yichang, Yichang, Hubei, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yang, Yaofeng" sort="Yang, Yaofeng" uniqKey="Yang Y" first="Yaofeng" last="Yang">Yaofeng Yang</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Xiao Gan First People's Hospital, Xiaogan, Hubei Province, China.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Leshan" sort="Liu, Leshan" uniqKey="Liu L" first="Leshan" last="Liu">Leshan Liu</name><affiliation><nlm:affiliation>Clinical Research Centre, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Qu, Jieming" sort="Qu, Jieming" uniqKey="Qu J" first="Jieming" last="Qu">Jieming Qu</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Ning, Guang" sort="Ning, Guang" uniqKey="Ning G" first="Guang" last="Ning">Guang Ning</name><affiliation><nlm:affiliation>Shanghai National Research Centre for Endocrine and Metabolic Diseases, State Key Laboratory of Medical Genomics, Shanghai Institute for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Shi, Guochao" sort="Shi, Guochao" uniqKey="Shi G" first="Guochao" last="Shi">Guochao Shi</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xie, Qing" sort="Xie, Qing" uniqKey="Xie Q" first="Qing" last="Xie">Qing Xie</name><affiliation><nlm:affiliation>Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China xieqingrjh@163.com.</nlm:affiliation></affiliation></author></analytic><series><title level="j">BMJ (Clinical research ed.)</title><idno type="eISSN">1756-1833</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>Antiviral Agents (therapeutic use)</term><term>COVID-19 (MeSH)</term><term>China (MeSH)</term><term>Coronavirus Infections (drug therapy)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (drug therapy)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>China</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>COVID-19</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Pandemics</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>To assess the efficacy and safety of hydroxychloroquine plus standard of care compared with standard of care alone in adults with coronavirus disease 2019 (covid-19).</p></div><div type="abstract" xml:lang="en"><p><b>DESIGN</b></p><p>Multicentre, open label, randomised controlled trial.</p></div><div type="abstract" xml:lang="en"><p><b>SETTING</b></p><p>16 government designated covid-19 treatment centres in China, 11 to 29 February 2020.</p></div><div type="abstract" xml:lang="en"><p><b>PARTICIPANTS</b></p><p>150 patients admitted to hospital with laboratory confirmed covid-19 were included in the intention to treat analysis (75 patients assigned to hydroxychloroquine plus standard of care, 75 to standard of care alone).</p></div><div type="abstract" xml:lang="en"><p><b>INTERVENTIONS</b></p><p>Hydroxychloroquine administrated at a loading dose of 1200 mg daily for three days followed by a maintenance dose of 800 mg daily (total treatment duration: two or three weeks for patients with mild to moderate or severe disease, respectively).</p></div><div type="abstract" xml:lang="en"><p><b>MAIN OUTCOME MEASURE</b></p><p>Negative conversion of severe acute respiratory syndrome coronavirus 2 by 28 days, analysed according to the intention to treat principle. Adverse events were analysed in the safety population in which hydroxychloroquine recipients were participants who received at least one dose of hydroxychloroquine and hydroxychloroquine non-recipients were those managed with standard of care alone.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Of 150 patients, 148 had mild to moderate disease and two had severe disease. The mean duration from symptom onset to randomisation was 16.6 (SD 10.5; range 3-41) days. A total of 109 (73%) patients (56 standard of care; 53 standard of care plus hydroxychloroquine) had negative conversion well before 28 days, and the remaining 41 (27%) patients (19 standard of care; 22 standard of care plus hydroxychloroquine) were censored as they did not reach negative conversion of virus. The probability of negative conversion by 28 days in the standard of care plus hydroxychloroquine group was 85.4% (95% confidence interval 73.8% to 93.8%), similar to that in the standard of care group (81.3%, 71.2% to 89.6%). The difference between groups was 4.1% (95% confidence interval -10.3% to 18.5%). In the safety population, adverse events were recorded in 7/80 (9%) hydroxychloroquine non-recipients and in 21/70 (30%) hydroxychloroquine recipients. The most common adverse event in the hydroxychloroquine recipients was diarrhoea, reported in 7/70 (10%) patients. Two hydroxychloroquine recipients reported serious adverse events.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19. Adverse events were higher in hydroxychloroquine recipients than in non-recipients.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>ChiCTR2000029868.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32409561</PMID><DateCompleted><Year>2020</Year><Month>05</Month><Day>19</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1756-1833</ISSN><JournalIssue CitedMedium="Internet"><Volume>369</Volume><PubDate><Year>2020</Year><Month>05</Month><Day>14</Day></PubDate></JournalIssue><Title>BMJ (Clinical research ed.)</Title><ISOAbbreviation>BMJ</ISOAbbreviation></Journal><ArticleTitle>Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.</ArticleTitle><Pagination><MedlinePgn>m1849</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1136/bmj.m1849</ELocationID><Abstract><AbstractText Label="OBJECTIVE">To assess the efficacy and safety of hydroxychloroquine plus standard of care compared with standard of care alone in adults with coronavirus disease 2019 (covid-19).</AbstractText><AbstractText Label="DESIGN">Multicentre, open label, randomised controlled trial.</AbstractText><AbstractText Label="SETTING">16 government designated covid-19 treatment centres in China, 11 to 29 February 2020.</AbstractText><AbstractText Label="PARTICIPANTS">150 patients admitted to hospital with laboratory confirmed covid-19 were included in the intention to treat analysis (75 patients assigned to hydroxychloroquine plus standard of care, 75 to standard of care alone).</AbstractText><AbstractText Label="INTERVENTIONS">Hydroxychloroquine administrated at a loading dose of 1200 mg daily for three days followed by a maintenance dose of 800 mg daily (total treatment duration: two or three weeks for patients with mild to moderate or severe disease, respectively).</AbstractText><AbstractText Label="MAIN OUTCOME MEASURE">Negative conversion of severe acute respiratory syndrome coronavirus 2 by 28 days, analysed according to the intention to treat principle. Adverse events were analysed in the safety population in which hydroxychloroquine recipients were participants who received at least one dose of hydroxychloroquine and hydroxychloroquine non-recipients were those managed with standard of care alone.</AbstractText><AbstractText Label="RESULTS">Of 150 patients, 148 had mild to moderate disease and two had severe disease. The mean duration from symptom onset to randomisation was 16.6 (SD 10.5; range 3-41) days. A total of 109 (73%) patients (56 standard of care; 53 standard of care plus hydroxychloroquine) had negative conversion well before 28 days, and the remaining 41 (27%) patients (19 standard of care; 22 standard of care plus hydroxychloroquine) were censored as they did not reach negative conversion of virus. The probability of negative conversion by 28 days in the standard of care plus hydroxychloroquine group was 85.4% (95% confidence interval 73.8% to 93.8%), similar to that in the standard of care group (81.3%, 71.2% to 89.6%). The difference between groups was 4.1% (95% confidence interval -10.3% to 18.5%). In the safety population, adverse events were recorded in 7/80 (9%) hydroxychloroquine non-recipients and in 21/70 (30%) hydroxychloroquine recipients. The most common adverse event in the hydroxychloroquine recipients was diarrhoea, reported in 7/70 (10%) patients. Two hydroxychloroquine recipients reported serious adverse events.</AbstractText><AbstractText Label="CONCLUSIONS">Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19. Adverse events were higher in hydroxychloroquine recipients than in non-recipients.</AbstractText><AbstractText Label="TRIAL REGISTRATION">ChiCTR2000029868.</AbstractText><CopyrightInformation>© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Tang</LastName><ForeName>Wei</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cao</LastName><ForeName>Zhujun</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Han</LastName><ForeName>Mingfeng</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Respiratory Medicine, No 2 People's Hospital of Fuyang City, Fuyang, Anhui, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Zhengyan</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Department of Respiratory Medicine, Suizhou Hospital, Hubei University of Medicine, Suizhou, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Junwen</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Respiratory and Critical Care Medicine, Xiangyang No 1 People's Hospital, Hubei University of Medicine, Xiangyang, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sun</LastName><ForeName>Wenjin</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Central Hospital of Ezhou, Ezhou, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wu</LastName><ForeName>Yaojie</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Cardiovascular Medicine, Yunmeng People's Hospital, Xiaogan, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xiao</LastName><ForeName>Wei</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Respiratory Medicine, First People's Hospital of Jingzhou City, Jingzhou, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Shengyong</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Erzhen</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Emergency Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Wei</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Xiongbiao</ForeName><Initials>X</Initials><AffiliationInfo><Affiliation>Department of Respiratory Medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yang</LastName><ForeName>Jiuyong</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Respiratory Medicine, Hubei Space Hospital of Xiaogan, Xiaogan, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lin</LastName><ForeName>Jun</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhao</LastName><ForeName>Qingxia</ForeName><Initials>Q</Initials><AffiliationInfo><Affiliation>Department of Infectious Disease, The Sixth People's Hospital of Zhengzhou, Zhengzhou, Henan, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yan</LastName><ForeName>Youqin</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Infectious Disease, Wuhan No 7 Hospital, Wuhan, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xie</LastName><ForeName>Zhibin</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Departments of Respiratory Medicine, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China xieqingrjh@163.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Dan</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Respiratory Medicine, The Third People's Hospital of Yichang, Yichang, Hubei, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yang</LastName><ForeName>Yaofeng</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Respiratory Medicine, Xiao Gan First People's Hospital, Xiaogan, Hubei Province, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Leshan</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Clinical Research Centre, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Qu</LastName><ForeName>Jieming</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ning</LastName><ForeName>Guang</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Shanghai National Research Centre for Endocrine and Metabolic Diseases, State Key Laboratory of Medical Genomics, Shanghai Institute for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shi</LastName><ForeName>Guochao</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xie</LastName><ForeName>Qing</ForeName><Initials>Q</Initials><Identifier Source="ORCID">0000-0002-2582-8803</Identifier><AffiliationInfo><Affiliation>Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China xieqingrjh@163.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>05</Month><Day>14</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMJ</MedlineTA><NlmUniqueID>8900488</NlmUniqueID><ISSNLinking>0959-8138</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections 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MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><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="D058873" MajorTopicYN="N">Pandemics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><CoiStatement>Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any 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