Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID-19 Infection.
Identifieur interne : 001096 ( Main/Corpus ); précédent : 001095; suivant : 001097Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID-19 Infection.
Auteurs : Melanie R. Nicol ; Abhay Joshi ; Matthew L. Rizk ; Philip E. Sabato ; Radojka M. Savic ; David Wesche ; Jenny H. Zheng ; Jack CookSource :
- Clinical pharmacology and therapeutics [ 1532-6535 ] ; 2020.
English descriptors
- KwdEn :
- Age Factors (MeSH), Aging (MeSH), Antiviral Agents (administration & dosage), Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), COVID-19 (drug therapy), Chloroquine (adverse effects), Chloroquine (pharmacokinetics), Chloroquine (pharmacology), Chloroquine (therapeutic use), Clinical Trials, Phase II as Topic (MeSH), Clinical Trials, Phase III as Topic (MeSH), Drug Interactions (MeSH), Drug Therapy, Combination (MeSH), Humans (MeSH), Hydroxychloroquine (adverse effects), Hydroxychloroquine (pharmacokinetics), Hydroxychloroquine (pharmacology), Hydroxychloroquine (therapeutic use), Liver Failure (epidemiology), Malaria (drug therapy), Prospective Studies (MeSH), Renal Insufficiency (epidemiology), SARS-CoV-2 (MeSH).
- MESH :
- chemical , administration & dosage : Antiviral Agents.
- chemical , adverse effects : Antiviral Agents, Chloroquine, Hydroxychloroquine.
- chemical , pharmacokinetics : Chloroquine, Hydroxychloroquine.
- chemical , pharmacology : Chloroquine, Hydroxychloroquine.
- chemical , therapeutic use : Antiviral Agents, Chloroquine, Hydroxychloroquine.
- drug therapy : COVID-19, Malaria.
- epidemiology : Liver Failure, Renal Insufficiency.
- Age Factors, Aging, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Drug Interactions, Drug Therapy, Combination, Humans, Prospective Studies, SARS-CoV-2.
Abstract
Chloroquine and hydroxychloroquine are quinoline derivatives used to treat malaria. To date, these medications are not approved for the treatment of viral infections, and there are no well-controlled, prospective, randomized clinical studies or evidence to support their use in patients with coronavirus disease 2019 (COVID-19). Nevertheless, chloroquine and hydroxychloroquine are being studied alone or in combination with other agents to assess their effectiveness in the treatment or prophylaxis for COVID-19. The effective use of any medication involves an understanding of its pharmacokinetics, safety, and mechanism of action. This work provides basic clinical pharmacology information relevant for planning and initiating COVID-19 clinical studies with chloroquine or hydroxychloroquine, summarizes safety data from healthy volunteer studies, and summarizes safety data from phase II and phase II/III clinical studies in patients with uncomplicated malaria, including a phase II/III study in pediatric patients following administration of azithromycin and chloroquine in combination. In addition, this work presents data describing the proposed mechanisms of action against the severe acute respiratory distress syndrome coronavirus-2 and summarizes clinical efficacy to date.
DOI: 10.1002/cpt.1993
PubMed: 32687630
PubMed Central: PMC7404755
Links to Exploration step
pubmed:32687630Le document en format XML
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Rizk</name><affiliation><nlm:affiliation>Quantitative Pharmacology and Pharmacometrics, Merck & Co Inc, Kenilworth, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sabato, Philip E" sort="Sabato, Philip E" uniqKey="Sabato P" first="Philip E" last="Sabato">Philip E. Sabato</name><affiliation><nlm:affiliation>Quantitative Pharmacology and Pharmacometrics, Merck & Co Inc, Kenilworth, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Savic, Radojka M" sort="Savic, Radojka M" uniqKey="Savic R" first="Radojka M" last="Savic">Radojka M. Savic</name><affiliation><nlm:affiliation>Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Wesche, David" sort="Wesche, David" uniqKey="Wesche D" first="David" last="Wesche">David Wesche</name><affiliation><nlm:affiliation>Certara, Princeton, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Zheng, Jenny H" sort="Zheng, Jenny H" uniqKey="Zheng J" first="Jenny H" last="Zheng">Jenny H. 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Nicol</name><affiliation><nlm:affiliation>Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Joshi, Abhay" sort="Joshi, Abhay" uniqKey="Joshi A" first="Abhay" last="Joshi">Abhay Joshi</name><affiliation><nlm:affiliation>Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Rizk, Matthew L" sort="Rizk, Matthew L" uniqKey="Rizk M" first="Matthew L" last="Rizk">Matthew L. Rizk</name><affiliation><nlm:affiliation>Quantitative Pharmacology and Pharmacometrics, Merck & Co Inc, Kenilworth, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sabato, Philip E" sort="Sabato, Philip E" uniqKey="Sabato P" first="Philip E" last="Sabato">Philip E. Sabato</name><affiliation><nlm:affiliation>Quantitative Pharmacology and Pharmacometrics, Merck & Co Inc, Kenilworth, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Savic, Radojka M" sort="Savic, Radojka M" uniqKey="Savic R" first="Radojka M" last="Savic">Radojka M. Savic</name><affiliation><nlm:affiliation>Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Wesche, David" sort="Wesche, David" uniqKey="Wesche D" first="David" last="Wesche">David Wesche</name><affiliation><nlm:affiliation>Certara, Princeton, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Zheng, Jenny H" sort="Zheng, Jenny H" uniqKey="Zheng J" first="Jenny H" last="Zheng">Jenny H. Zheng</name><affiliation><nlm:affiliation>Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Cook, Jack" sort="Cook, Jack" uniqKey="Cook J" first="Jack" last="Cook">Jack Cook</name><affiliation><nlm:affiliation>Clinical Pharmacology Department, Global Product Development, Pfizer Inc, Groton, Connecticut, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Clinical pharmacology and therapeutics</title><idno type="eISSN">1532-6535</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Age Factors (MeSH)</term><term>Aging (MeSH)</term><term>Antiviral Agents (administration & dosage)</term><term>Antiviral Agents (adverse effects)</term><term>Antiviral Agents (therapeutic use)</term><term>COVID-19 (drug therapy)</term><term>Chloroquine (adverse effects)</term><term>Chloroquine (pharmacokinetics)</term><term>Chloroquine (pharmacology)</term><term>Chloroquine (therapeutic use)</term><term>Clinical Trials, Phase II as Topic (MeSH)</term><term>Clinical Trials, Phase III as Topic (MeSH)</term><term>Drug Interactions (MeSH)</term><term>Drug Therapy, Combination (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (adverse effects)</term><term>Hydroxychloroquine (pharmacokinetics)</term><term>Hydroxychloroquine (pharmacology)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Liver Failure (epidemiology)</term><term>Malaria (drug therapy)</term><term>Prospective Studies (MeSH)</term><term>Renal Insufficiency (epidemiology)</term><term>SARS-CoV-2 (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiviral Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term><term>Malaria</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Liver Failure</term><term>Renal Insufficiency</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Age Factors</term><term>Aging</term><term>Clinical Trials, Phase II as Topic</term><term>Clinical Trials, Phase III as Topic</term><term>Drug Interactions</term><term>Drug Therapy, Combination</term><term>Humans</term><term>Prospective Studies</term><term>SARS-CoV-2</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Chloroquine and hydroxychloroquine are quinoline derivatives used to treat malaria. To date, these medications are not approved for the treatment of viral infections, and there are no well-controlled, prospective, randomized clinical studies or evidence to support their use in patients with coronavirus disease 2019 (COVID-19). Nevertheless, chloroquine and hydroxychloroquine are being studied alone or in combination with other agents to assess their effectiveness in the treatment or prophylaxis for COVID-19. The effective use of any medication involves an understanding of its pharmacokinetics, safety, and mechanism of action. This work provides basic clinical pharmacology information relevant for planning and initiating COVID-19 clinical studies with chloroquine or hydroxychloroquine, summarizes safety data from healthy volunteer studies, and summarizes safety data from phase II and phase II/III clinical studies in patients with uncomplicated malaria, including a phase II/III study in pediatric patients following administration of azithromycin and chloroquine in combination. In addition, this work presents data describing the proposed mechanisms of action against the severe acute respiratory distress syndrome coronavirus-2 and summarizes clinical efficacy to date.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32687630</PMID><DateCompleted><Year>2020</Year><Month>12</Month><Day>04</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>14</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1532-6535</ISSN><JournalIssue CitedMedium="Internet"><Volume>108</Volume><Issue>6</Issue><PubDate><Year>2020</Year><Month>12</Month></PubDate></JournalIssue><Title>Clinical pharmacology and therapeutics</Title><ISOAbbreviation>Clin Pharmacol Ther</ISOAbbreviation></Journal><ArticleTitle>Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID-19 Infection.</ArticleTitle><Pagination><MedlinePgn>1135-1149</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/cpt.1993</ELocationID><Abstract><AbstractText>Chloroquine and hydroxychloroquine are quinoline derivatives used to treat malaria. To date, these medications are not approved for the treatment of viral infections, and there are no well-controlled, prospective, randomized clinical studies or evidence to support their use in patients with coronavirus disease 2019 (COVID-19). Nevertheless, chloroquine and hydroxychloroquine are being studied alone or in combination with other agents to assess their effectiveness in the treatment or prophylaxis for COVID-19. The effective use of any medication involves an understanding of its pharmacokinetics, safety, and mechanism of action. This work provides basic clinical pharmacology information relevant for planning and initiating COVID-19 clinical studies with chloroquine or hydroxychloroquine, summarizes safety data from healthy volunteer studies, and summarizes safety data from phase II and phase II/III clinical studies in patients with uncomplicated malaria, including a phase II/III study in pediatric patients following administration of azithromycin and chloroquine in combination. In addition, this work presents data describing the proposed mechanisms of action against the severe acute respiratory distress syndrome coronavirus-2 and summarizes clinical efficacy to date.</AbstractText><CopyrightInformation>© 2020 The Authors Clinical Pharmacology & Therapeutics © 2020 American Society for Clinical Pharmacology and Therapeutics.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Nicol</LastName><ForeName>Melanie R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Joshi</LastName><ForeName>Abhay</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rizk</LastName><ForeName>Matthew L</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Quantitative Pharmacology and Pharmacometrics, Merck & Co Inc, Kenilworth, New Jersey, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sabato</LastName><ForeName>Philip E</ForeName><Initials>PE</Initials><AffiliationInfo><Affiliation>Quantitative Pharmacology and Pharmacometrics, Merck & Co Inc, Kenilworth, New Jersey, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Savic</LastName><ForeName>Radojka M</ForeName><Initials>RM</Initials><AffiliationInfo><Affiliation>Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wesche</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Certara, Princeton, New Jersey, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zheng</LastName><ForeName>Jenny H</ForeName><Initials>JH</Initials><AffiliationInfo><Affiliation>Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cook</LastName><ForeName>Jack</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Clinical Pharmacology Department, Global Product Development, Pfizer Inc, Groton, Connecticut, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><Agency>Pfizer Inc</Agency><Country>International</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>09</Month><Day>01</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Pharmacol Ther</MedlineTA><NlmUniqueID>0372741</NlmUniqueID><ISSNLinking>0009-9236</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical><Chemical><RegistryNumber>886U3H6UFF</RegistryNumber><NameOfSubstance UI="D002738">Chloroquine</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000367" MajorTopicYN="N">Age Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000375" MajorTopicYN="N">Aging</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000998" MajorTopicYN="N">Antiviral Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002738" MajorTopicYN="N">Chloroquine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000493" MajorTopicYN="N">pharmacokinetics</QualifierName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017322" MajorTopicYN="N">Clinical Trials, Phase II as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017326" MajorTopicYN="N">Clinical Trials, Phase III as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004347" MajorTopicYN="N">Drug Interactions</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000493" MajorTopicYN="N">pharmacokinetics</QualifierName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017093" MajorTopicYN="N">Liver Failure</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008288" MajorTopicYN="N">Malaria</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D051437" MajorTopicYN="N">Renal Insufficiency</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>05</Month><Day>12</Day></PubMedPubDate><PubMedPubDate 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