Clinical Characteristics and Outcomes of COVID-19 Patients Receiving Compassionate Use Leronlimab.
Identifieur interne : 000989 ( Main/Corpus ); précédent : 000988; suivant : 000990Clinical Characteristics and Outcomes of COVID-19 Patients Receiving Compassionate Use Leronlimab.
Auteurs : Bryant Yang ; Jennifer A. Fulcher ; Jenny Ahn ; Marlene Berro ; David Goodman-Meza ; Kush Dhody ; Jonah B. Sacha ; Arash Naeim ; Otto O. YangSource :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [ 1537-6591 ] ; 2020.
Abstract
BACKGROUND
Leronlimab, a monoclonal antibody blocker of CCR5 originally developed to treat HIV-1 infection, was administered as an open label compassionate use therapeutic for COVID-19.
METHODS
23 hospitalized severe/critical COVID-19 patients received 700mg leronlimab subcutaneously, repeated after seven days in 17/23 patients still hospitalized. 18/23 received other experimental treatments, including convalescent plasma, hydroxychloroquine, steroids, and/or tocilizumab. 5/23 received leronlimab after blinded placebo-controlled trials of remdesivir, sarilumab, selinexor, or tocilizumab. Outcomes and results were extracted from medical records.
RESULTS
Mean age was 69.5±14.9 years. 20/23 had significant co-morbidities. At baseline, 22/23 were receiving supplemental oxygen (3/23 high flow, 7/23 mechanical ventilation). Blood showed markedly elevated inflammatory markers (ferritin, D-dimer, C-reactive protein) and elevated neutrophil:lymphocyte ratio. By day 30 after initial dosing, 17/23 were recovered, 2/23 were still hospitalized, and 4/23 had died. Of the 7 intubated at baseline, 4/7 were fully recovered off oxygen, 2/7 were still hospitalized, and 1/7 had died.
CONCLUSIONS
Leronlimab appeared safe and well tolerated. The high recovery rate suggested benefit, and those with lower inflammatory markers had better outcomes. Some but not all patients appeared to have dramatic clinical responses, indicating that unknown factors may determine responsiveness to leronlimab. Routine inflammatory and cell prognostic markers did not markedly change immediately after treatment, although IL-6 tended to fall. In some persons C-reactive protein clearly dropped only after the second leronlimab dose, suggesting that a higher loading dose might be more effective. Future controlled trials will be informative.
DOI: 10.1093/cid/ciaa1583
PubMed: 33079180
PubMed Central: PMC7665416
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Fulcher</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>VA Greater Los Angeles Healthcare System, Los Angeles, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Ahn, Jenny" sort="Ahn, Jenny" uniqKey="Ahn J" first="Jenny" last="Ahn">Jenny Ahn</name><affiliation><nlm:affiliation>Clinical and Translational Science Institute Office of Clinical Research, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Berro, Marlene" sort="Berro, Marlene" uniqKey="Berro M" first="Marlene" last="Berro">Marlene Berro</name><affiliation><nlm:affiliation>Clinical and Translational Science Institute Office of Clinical Research, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Goodman Meza, David" sort="Goodman Meza, David" uniqKey="Goodman Meza D" first="David" last="Goodman-Meza">David Goodman-Meza</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Dhody, Kush" sort="Dhody, Kush" uniqKey="Dhody K" first="Kush" last="Dhody">Kush Dhody</name><affiliation><nlm:affiliation>Amarex Clinical Research, LLC, Germantown, MD.</nlm:affiliation></affiliation></author><author><name sortKey="Sacha, Jonah B" sort="Sacha, Jonah B" uniqKey="Sacha J" first="Jonah B" last="Sacha">Jonah B. 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Fulcher</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>VA Greater Los Angeles Healthcare System, Los Angeles, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Ahn, Jenny" sort="Ahn, Jenny" uniqKey="Ahn J" first="Jenny" last="Ahn">Jenny Ahn</name><affiliation><nlm:affiliation>Clinical and Translational Science Institute Office of Clinical Research, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Berro, Marlene" sort="Berro, Marlene" uniqKey="Berro M" first="Marlene" last="Berro">Marlene Berro</name><affiliation><nlm:affiliation>Clinical and Translational Science Institute Office of Clinical Research, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Goodman Meza, David" sort="Goodman Meza, David" uniqKey="Goodman Meza D" first="David" last="Goodman-Meza">David Goodman-Meza</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Dhody, Kush" sort="Dhody, Kush" uniqKey="Dhody K" first="Kush" last="Dhody">Kush Dhody</name><affiliation><nlm:affiliation>Amarex Clinical Research, LLC, Germantown, MD.</nlm:affiliation></affiliation></author><author><name sortKey="Sacha, Jonah B" sort="Sacha, Jonah B" uniqKey="Sacha J" first="Jonah B" last="Sacha">Jonah B. Sacha</name><affiliation><nlm:affiliation>Vaccine and Gene Therapy Institute and Oregon National Primate Research Center, Oregon Health & Science University, Beaverton, OR.</nlm:affiliation></affiliation></author><author><name sortKey="Naeim, Arash" sort="Naeim, Arash" uniqKey="Naeim A" first="Arash" last="Naeim">Arash Naeim</name><affiliation><nlm:affiliation>Clinical and Translational Science Institute Office of Clinical Research, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Yang, Otto O" sort="Yang, Otto O" uniqKey="Yang O" first="Otto O" last="Yang">Otto O. Yang</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Microbiology, Immunology, and Molecular Genetics, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</title><idno type="eISSN">1537-6591</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Leronlimab, a monoclonal antibody blocker of CCR5 originally developed to treat HIV-1 infection, was administered as an open label compassionate use therapeutic for COVID-19.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>23 hospitalized severe/critical COVID-19 patients received 700mg leronlimab subcutaneously, repeated after seven days in 17/23 patients still hospitalized. 18/23 received other experimental treatments, including convalescent plasma, hydroxychloroquine, steroids, and/or tocilizumab. 5/23 received leronlimab after blinded placebo-controlled trials of remdesivir, sarilumab, selinexor, or tocilizumab. Outcomes and results were extracted from medical records.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Mean age was 69.5±14.9 years. 20/23 had significant co-morbidities. At baseline, 22/23 were receiving supplemental oxygen (3/23 high flow, 7/23 mechanical ventilation). Blood showed markedly elevated inflammatory markers (ferritin, D-dimer, C-reactive protein) and elevated neutrophil:lymphocyte ratio. By day 30 after initial dosing, 17/23 were recovered, 2/23 were still hospitalized, and 4/23 had died. Of the 7 intubated at baseline, 4/7 were fully recovered off oxygen, 2/7 were still hospitalized, and 1/7 had died.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Leronlimab appeared safe and well tolerated. The high recovery rate suggested benefit, and those with lower inflammatory markers had better outcomes. Some but not all patients appeared to have dramatic clinical responses, indicating that unknown factors may determine responsiveness to leronlimab. Routine inflammatory and cell prognostic markers did not markedly change immediately after treatment, although IL-6 tended to fall. In some persons C-reactive protein clearly dropped only after the second leronlimab dose, suggesting that a higher loading dose might be more effective. Future controlled trials will be informative.</p></div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">33079180</PMID><DateRevised><Year>2020</Year><Month>12</Month><Day>16</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1537-6591</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Oct</Month><Day>20</Day></PubDate></JournalIssue><Title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</Title><ISOAbbreviation>Clin Infect Dis</ISOAbbreviation></Journal><ArticleTitle>Clinical Characteristics and Outcomes of COVID-19 Patients Receiving Compassionate Use Leronlimab.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">ciaa1583</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1093/cid/ciaa1583</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Leronlimab, a monoclonal antibody blocker of CCR5 originally developed to treat HIV-1 infection, was administered as an open label compassionate use therapeutic for COVID-19.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">23 hospitalized severe/critical COVID-19 patients received 700mg leronlimab subcutaneously, repeated after seven days in 17/23 patients still hospitalized. 18/23 received other experimental treatments, including convalescent plasma, hydroxychloroquine, steroids, and/or tocilizumab. 5/23 received leronlimab after blinded placebo-controlled trials of remdesivir, sarilumab, selinexor, or tocilizumab. Outcomes and results were extracted from medical records.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Mean age was 69.5±14.9 years. 20/23 had significant co-morbidities. At baseline, 22/23 were receiving supplemental oxygen (3/23 high flow, 7/23 mechanical ventilation). Blood showed markedly elevated inflammatory markers (ferritin, D-dimer, C-reactive protein) and elevated neutrophil:lymphocyte ratio. By day 30 after initial dosing, 17/23 were recovered, 2/23 were still hospitalized, and 4/23 had died. Of the 7 intubated at baseline, 4/7 were fully recovered off oxygen, 2/7 were still hospitalized, and 1/7 had died.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Leronlimab appeared safe and well tolerated. The high recovery rate suggested benefit, and those with lower inflammatory markers had better outcomes. Some but not all patients appeared to have dramatic clinical responses, indicating that unknown factors may determine responsiveness to leronlimab. Routine inflammatory and cell prognostic markers did not markedly change immediately after treatment, although IL-6 tended to fall. In some persons C-reactive protein clearly dropped only after the second leronlimab dose, suggesting that a higher loading dose might be more effective. Future controlled trials will be informative.</AbstractText><CopyrightInformation>© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Yang</LastName><ForeName>Bryant</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fulcher</LastName><ForeName>Jennifer A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>VA Greater Los Angeles Healthcare System, Los Angeles, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ahn</LastName><ForeName>Jenny</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Clinical and Translational Science Institute Office of Clinical Research, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Berro</LastName><ForeName>Marlene</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Clinical and Translational Science Institute Office of Clinical Research, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goodman-Meza</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dhody</LastName><ForeName>Kush</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Amarex Clinical Research, LLC, Germantown, MD.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sacha</LastName><ForeName>Jonah B</ForeName><Initials>JB</Initials><AffiliationInfo><Affiliation>Vaccine and Gene Therapy Institute and Oregon National Primate Research Center, Oregon Health & Science University, Beaverton, OR.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Naeim</LastName><ForeName>Arash</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Clinical and Translational Science Institute Office of Clinical Research, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yang</LastName><ForeName>Otto O</ForeName><Initials>OO</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Microbiology, Immunology, and Molecular Genetics, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>UL1 TR001881</GrantID><Acronym>TR</Acronym><Agency>NCATS NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>10</Month><Day>20</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Infect Dis</MedlineTA><NlmUniqueID>9203213</NlmUniqueID><ISSNLinking>1058-4838</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">SARS-CoV-2</Keyword><Keyword MajorTopicYN="N">immunomodulatory therapy</Keyword><Keyword MajorTopicYN="N">leronlimab</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>08</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>10</Month><Day>20</Day><Hour>12</Hour><Minute>12</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>10</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>10</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33079180</ArticleId><ArticleId IdType="pii">5932277</ArticleId><ArticleId IdType="doi">10.1093/cid/ciaa1583</ArticleId><ArticleId IdType="pmc">PMC7665416</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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