[A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19].
Identifieur interne : 001742 ( Main/Corpus ); précédent : 001741; suivant : 001743[A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19].
Auteurs : Jun Chen ; Danping Liu ; Li Liu ; Ping Liu ; Qingnian Xu ; Lu Xia ; Yun Ling ; Dan Huang ; Shuli Song ; Dandan Zhang ; Zhiping Qian ; Tao Li ; Yinzhong Shen ; Hongzhou LuSource :
- Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences [ 1008-9292 ] ; 2020.
English descriptors
- KwdEn :
- Betacoronavirus (isolation & purification), COVID-19 (MeSH), China (MeSH), Coronavirus Infections (diagnostic imaging), Coronavirus Infections (drug therapy), Humans (MeSH), Hydroxychloroquine (therapeutic use), Pandemics (MeSH), Pilot Projects (MeSH), Pneumonia, Viral (diagnostic imaging), Pneumonia, Viral (drug therapy), RNA, Viral (isolation & purification), SARS-CoV-2 (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , isolation & purification : RNA, Viral.
- chemical , therapeutic use : Hydroxychloroquine.
- geographic : China.
- diagnostic imaging : Coronavirus Infections, Pneumonia, Viral.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- isolation & purification : Betacoronavirus.
- COVID-19, Humans, Pandemics, Pilot Projects, SARS-CoV-2, Treatment Outcome.
Abstract
OBJECTIVE
To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of patients with moderate coronavirus disease 2019 (COVID-19).
METHODS
We prospectively enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center. The patients were randomized 1：1 to HCQ group and the control group. Patients in HCQ group were given HCQ 400 mg per day for 5 days plus conventional treatments, while those in the control group were given conventional treatment only. The primary endpoint was negative conversion rate of SARS-CoV-2 nucleic acid in respiratory pharyngeal swab on days 7 after randomization. This study has been approved by the Ethics Committee of Shanghai Public Health Clinical Center and registered online (NCT04261517).
RESULTS
One patient in HCQ group developed to severe during the treatment. On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group (
CONCLUSIONS
The prognosis of COVID-19 moderate patients is good. Larger sample size study are needed to investigate the effects of HCQ in the treatment of COVID-19. Subsequent research should determine better endpoint and fully consider the feasibility of experiments such as sample size.
DOI: 10.3785/j.issn.1008-9292.2020.03.03
PubMed: 32391667
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pubmed:32391667Le document en format XML
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201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Ping" sort="Liu, Ping" uniqKey="Liu P" first="Ping" last="Liu">Ping Liu</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xu, Qingnian" sort="Xu, Qingnian" uniqKey="Xu Q" first="Qingnian" last="Xu">Qingnian Xu</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xia, Lu" sort="Xia, Lu" uniqKey="Xia L" first="Lu" last="Xia">Lu Xia</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Ling, Yun" sort="Ling, Yun" uniqKey="Ling Y" first="Yun" last="Ling">Yun Ling</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Dan" sort="Huang, Dan" uniqKey="Huang D" first="Dan" last="Huang">Dan Huang</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Song, Shuli" sort="Song, Shuli" uniqKey="Song S" first="Shuli" last="Song">Shuli Song</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Dandan" sort="Zhang, Dandan" uniqKey="Zhang D" first="Dandan" last="Zhang">Dandan Zhang</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Qian, Zhiping" sort="Qian, Zhiping" uniqKey="Qian Z" first="Zhiping" last="Qian">Zhiping Qian</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Li, Tao" sort="Li, Tao" uniqKey="Li T" first="Tao" last="Li">Tao Li</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Shen, Yinzhong" sort="Shen, Yinzhong" uniqKey="Shen Y" first="Yinzhong" last="Shen">Yinzhong Shen</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Lu, Hongzhou" sort="Lu, Hongzhou" uniqKey="Lu H" first="Hongzhou" last="Lu">Hongzhou Lu</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32391667</idno><idno type="pmid">32391667</idno><idno type="doi">10.3785/j.issn.1008-9292.2020.03.03</idno><idno type="wicri:Area/Main/Corpus">001742</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001742</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">[A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19].</title><author><name sortKey="Chen, Jun" sort="Chen, Jun" uniqKey="Chen J" first="Jun" last="Chen">Jun Chen</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Danping" sort="Liu, Danping" uniqKey="Liu D" first="Danping" last="Liu">Danping Liu</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Li" sort="Liu, Li" uniqKey="Liu L" first="Li" last="Liu">Li Liu</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Ping" sort="Liu, Ping" uniqKey="Liu P" first="Ping" last="Liu">Ping Liu</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xu, Qingnian" sort="Xu, Qingnian" uniqKey="Xu Q" first="Qingnian" last="Xu">Qingnian Xu</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Xia, Lu" sort="Xia, Lu" uniqKey="Xia L" first="Lu" last="Xia">Lu Xia</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Ling, Yun" sort="Ling, Yun" uniqKey="Ling Y" first="Yun" last="Ling">Yun Ling</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Dan" sort="Huang, Dan" uniqKey="Huang D" first="Dan" last="Huang">Dan Huang</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Song, Shuli" sort="Song, Shuli" uniqKey="Song S" first="Shuli" last="Song">Shuli Song</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Dandan" sort="Zhang, Dandan" uniqKey="Zhang D" first="Dandan" last="Zhang">Dandan Zhang</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Qian, Zhiping" sort="Qian, Zhiping" uniqKey="Qian Z" first="Zhiping" last="Qian">Zhiping Qian</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Li, Tao" sort="Li, Tao" uniqKey="Li T" first="Tao" last="Li">Tao Li</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Shen, Yinzhong" sort="Shen, Yinzhong" uniqKey="Shen Y" first="Yinzhong" last="Shen">Yinzhong Shen</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author><author><name sortKey="Lu, Hongzhou" sort="Lu, Hongzhou" uniqKey="Lu H" first="Hongzhou" last="Lu">Hongzhou Lu</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences</title><idno type="ISSN">1008-9292</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Betacoronavirus (isolation & purification)</term><term>COVID-19 (MeSH)</term><term>China (MeSH)</term><term>Coronavirus Infections (diagnostic imaging)</term><term>Coronavirus Infections (drug therapy)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Pandemics (MeSH)</term><term>Pilot Projects (MeSH)</term><term>Pneumonia, Viral (diagnostic imaging)</term><term>Pneumonia, Viral (drug therapy)</term><term>RNA, Viral (isolation & purification)</term><term>SARS-CoV-2 (MeSH)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="isolation & purification" xml:lang="en"><term>RNA, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>China</term></keywords><keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" xml:lang="en"><term>COVID-19</term><term>Humans</term><term>Pandemics</term><term>Pilot Projects</term><term>SARS-CoV-2</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of patients with moderate coronavirus disease 2019 (COVID-19).</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>We prospectively enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center. The patients were randomized 1：1 to HCQ group and the control group. Patients in HCQ group were given HCQ 400 mg per day for 5 days plus conventional treatments, while those in the control group were given conventional treatment only. The primary endpoint was negative conversion rate of SARS-CoV-2 nucleic acid in respiratory pharyngeal swab on days 7 after randomization. This study has been approved by the Ethics Committee of Shanghai Public Health Clinical Center and registered online (NCT04261517).</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>One patient in HCQ group developed to severe during the treatment. On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group (</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>The prognosis of COVID-19 moderate patients is good. Larger sample size study are needed to investigate the effects of HCQ in the treatment of COVID-19. Subsequent research should determine better endpoint and fully consider the feasibility of experiments such as sample size.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" IndexingMethod="Curated" Owner="NLM"><PMID Version="1">32391667</PMID><DateCompleted><Year>2020</Year><Month>05</Month><Day>12</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>18</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">1008-9292</ISSN><JournalIssue CitedMedium="Print"><Volume>49</Volume><Issue>2</Issue><PubDate><Year>2020</Year><Month>May</Month><Day>25</Day></PubDate></JournalIssue><Title>Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences</Title><ISOAbbreviation>Zhejiang Da Xue Xue Bao Yi Xue Ban</ISOAbbreviation></Journal><ArticleTitle>[A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19].</ArticleTitle><Pagination><MedlinePgn>215-219</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3785/j.issn.1008-9292.2020.03.03</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of patients with moderate coronavirus disease 2019 (COVID-19).</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We prospectively enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center. The patients were randomized 1：1 to HCQ group and the control group. Patients in HCQ group were given HCQ 400 mg per day for 5 days plus conventional treatments, while those in the control group were given conventional treatment only. The primary endpoint was negative conversion rate of SARS-CoV-2 nucleic acid in respiratory pharyngeal swab on days 7 after randomization. This study has been approved by the Ethics Committee of Shanghai Public Health Clinical Center and registered online (NCT04261517).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">One patient in HCQ group developed to severe during the treatment. On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group (<i>P</i>>0.05). The median duration from hospitalization to virus nucleic acid negative conservation was 4 (1,9) days in HCQ group, which is comparable to that in the control group [2 (1,4) days, Z=1.27, <i>P</i>>0.05]. The median time for body temperature normalization in HCQ group was 1 (0,2) day after hospitalization, which was also comparable to that in the control group [1 (0,3) day]. Radiological progression was shown on CT images in 5 cases (33.3%) of the HCQ group and 7 cases (46.7%) of the control group, and all patients showed improvement in follow-up examinations. Four cases (26.7%) of the HCQ group and 3 cases (20%) of the control group had transient diarrhea and abnormal liver function (<i>P</i>>0.05).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The prognosis of COVID-19 moderate patients is good. Larger sample size study are needed to investigate the effects of HCQ in the treatment of COVID-19. Subsequent research should determine better endpoint and fully consider the feasibility of experiments such as sample size.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Jun</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Danping</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Li</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Ping</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xu</LastName><ForeName>Qingnian</ForeName><Initials>Q</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xia</LastName><ForeName>Lu</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ling</LastName><ForeName>Yun</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huang</LastName><ForeName>Dan</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Song</LastName><ForeName>Shuli</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Dandan</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Qian</LastName><ForeName>Zhiping</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Tao</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shen</LastName><ForeName>Yinzhong</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lu</LastName><ForeName>Hongzhou</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.</Affiliation></AffiliationInfo></Author></AuthorList><Language>chi</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04261517</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>China</Country><MedlineTA>Zhejiang Da Xue Xue Bao Yi Xue Ban</MedlineTA><NlmUniqueID>100927946</NlmUniqueID><ISSNLinking>1008-9292</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D012367">RNA, 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