Clinical Experience with Use of Remdesivir in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2: a Case Series.
Identifieur interne : 000F72 ( Main/Corpus ); précédent : 000F71; suivant : 000F73Clinical Experience with Use of Remdesivir in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2: a Case Series.
Auteurs : Choongman Lee ; Mi Young Ahn ; Kyeongmin Byeon ; Jae Phil Choi ; Chorom Hahm ; Hyeonmok Kim ; Suhyun Kim ; Tae Ho Kim ; Jungkyun Oh ; Dong Hyun OhSource :
- Infection & chemotherapy [ 2093-2340 ] ; 2020.
Abstract
BACKGROUND
A novel antiviral agent, remdesivir (RDV), is a promising candidate treatment for coronavirus disease 2019 (COVID-19) in the absence of any proven therapy.
MATERIALS AND METHODS
This retrospective case series included 10 patients with a clinically and laboratory confirmed diagnosis of severe COVID-19 pneumonia who had received RDV for 5 days (n = 5) or 10 days (n = 5) in the Phase III clinical trial of RDV (GS-US-540-5773) conducted by Gilead Sciences. The clinical and laboratory data for these patients were extracted.
RESULTS
One patient in the 10-day group received RDV for only 5 days because of nausea and elevated liver transaminases. No patient had respiratory comorbidity. Seven patients had bilateral lesions and three had unilateral lesions on imaging. All patients had received other medications for COVID-19, including lopinavir/ritonavir and hydroxychloroquine, before administration of RDV. Five patients required supplemental oxygen and one required mechanical ventilation. All patients showed clinical and laboratory evidence of improvement. Half of the patients developed elevated liver transaminases and three had nausea. There were no adverse events exceeding grade 2.
CONCLUSION
Our experience indicates that RDV could be a therapeutic option for COVID-19. A well-designed randomized controlled clinical trial is now needed to confirm the efficacy of RDV in patients with COVID-19.
DOI: 10.3947/ic.2020.52.3.369
PubMed: 32757500
PubMed Central: PMC7533211
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Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Choi, Jae Phil" sort="Choi, Jae Phil" uniqKey="Choi J" first="Jae Phil" last="Choi">Jae Phil Choi</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Hahm, Chorom" sort="Hahm, Chorom" uniqKey="Hahm C" first="Chorom" last="Hahm">Chorom Hahm</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Hyeonmok" sort="Kim, Hyeonmok" uniqKey="Kim H" first="Hyeonmok" last="Kim">Hyeonmok Kim</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Suhyun" sort="Kim, Suhyun" uniqKey="Kim S" first="Suhyun" last="Kim">Suhyun Kim</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Tae Ho" sort="Kim, Tae Ho" uniqKey="Kim T" first="Tae Ho" last="Kim">Tae Ho Kim</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Oh, Jungkyun" sort="Oh, Jungkyun" uniqKey="Oh J" first="Jungkyun" last="Oh">Jungkyun Oh</name><affiliation><nlm:affiliation>Department of Hospital Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Oh, Dong Hyun" sort="Oh, Dong Hyun" uniqKey="Oh D" first="Dong Hyun" last="Oh">Dong Hyun Oh</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea. nemesisx2000@gmail.com.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32757500</idno><idno type="pmid">32757500</idno><idno type="doi">10.3947/ic.2020.52.3.369</idno><idno type="pmc">PMC7533211</idno><idno type="wicri:Area/Main/Corpus">000F72</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000F72</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Clinical Experience with Use of Remdesivir in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2: a Case Series.</title><author><name sortKey="Lee, Choongman" sort="Lee, Choongman" uniqKey="Lee C" first="Choongman" last="Lee">Choongman Lee</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Ahn, Mi Young" sort="Ahn, Mi Young" uniqKey="Ahn M" first="Mi Young" last="Ahn">Mi Young Ahn</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Byeon, Kyeongmin" sort="Byeon, Kyeongmin" uniqKey="Byeon K" first="Kyeongmin" last="Byeon">Kyeongmin Byeon</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Choi, Jae Phil" sort="Choi, Jae Phil" uniqKey="Choi J" first="Jae Phil" last="Choi">Jae Phil Choi</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Hahm, Chorom" sort="Hahm, Chorom" uniqKey="Hahm C" first="Chorom" last="Hahm">Chorom Hahm</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Hyeonmok" sort="Kim, Hyeonmok" uniqKey="Kim H" first="Hyeonmok" last="Kim">Hyeonmok Kim</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Suhyun" sort="Kim, Suhyun" uniqKey="Kim S" first="Suhyun" last="Kim">Suhyun Kim</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Tae Ho" sort="Kim, Tae Ho" uniqKey="Kim T" first="Tae Ho" last="Kim">Tae Ho Kim</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Oh, Jungkyun" sort="Oh, Jungkyun" uniqKey="Oh J" first="Jungkyun" last="Oh">Jungkyun Oh</name><affiliation><nlm:affiliation>Department of Hospital Medicine, Seoul Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Oh, Dong Hyun" sort="Oh, Dong Hyun" uniqKey="Oh D" first="Dong Hyun" last="Oh">Dong Hyun Oh</name><affiliation><nlm:affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea. nemesisx2000@gmail.com.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Infection & chemotherapy</title><idno type="ISSN">2093-2340</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>A novel antiviral agent, remdesivir (RDV), is a promising candidate treatment for coronavirus disease 2019 (COVID-19) in the absence of any proven therapy.</p></div><div type="abstract" xml:lang="en"><p><b>MATERIALS AND METHODS</b></p><p>This retrospective case series included 10 patients with a clinically and laboratory confirmed diagnosis of severe COVID-19 pneumonia who had received RDV for 5 days (n = 5) or 10 days (n = 5) in the Phase III clinical trial of RDV (GS-US-540-5773) conducted by Gilead Sciences. The clinical and laboratory data for these patients were extracted.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>One patient in the 10-day group received RDV for only 5 days because of nausea and elevated liver transaminases. No patient had respiratory comorbidity. Seven patients had bilateral lesions and three had unilateral lesions on imaging. All patients had received other medications for COVID-19, including lopinavir/ritonavir and hydroxychloroquine, before administration of RDV. Five patients required supplemental oxygen and one required mechanical ventilation. All patients showed clinical and laboratory evidence of improvement. Half of the patients developed elevated liver transaminases and three had nausea. There were no adverse events exceeding grade 2.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>Our experience indicates that RDV could be a therapeutic option for COVID-19. A well-designed randomized controlled clinical trial is now needed to confirm the efficacy of RDV in patients with COVID-19.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">32757500</PMID><DateRevised><Year>2020</Year><Month>10</Month><Day>16</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">2093-2340</ISSN><JournalIssue CitedMedium="Print"><Volume>52</Volume><Issue>3</Issue><PubDate><Year>2020</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Infection & chemotherapy</Title><ISOAbbreviation>Infect Chemother</ISOAbbreviation></Journal><ArticleTitle>Clinical Experience with Use of Remdesivir in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2: a Case Series.</ArticleTitle><Pagination><MedlinePgn>369-380</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3947/ic.2020.52.3.369</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">A novel antiviral agent, remdesivir (RDV), is a promising candidate treatment for coronavirus disease 2019 (COVID-19) in the absence of any proven therapy.</AbstractText><AbstractText Label="MATERIALS AND METHODS" NlmCategory="METHODS">This retrospective case series included 10 patients with a clinically and laboratory confirmed diagnosis of severe COVID-19 pneumonia who had received RDV for 5 days (n = 5) or 10 days (n = 5) in the Phase III clinical trial of RDV (GS-US-540-5773) conducted by Gilead Sciences. The clinical and laboratory data for these patients were extracted.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">One patient in the 10-day group received RDV for only 5 days because of nausea and elevated liver transaminases. No patient had respiratory comorbidity. Seven patients had bilateral lesions and three had unilateral lesions on imaging. All patients had received other medications for COVID-19, including lopinavir/ritonavir and hydroxychloroquine, before administration of RDV. Five patients required supplemental oxygen and one required mechanical ventilation. All patients showed clinical and laboratory evidence of improvement. Half of the patients developed elevated liver transaminases and three had nausea. There were no adverse events exceeding grade 2.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Our experience indicates that RDV could be a therapeutic option for COVID-19. A well-designed randomized controlled clinical trial is now needed to confirm the efficacy of RDV in patients with COVID-19.</AbstractText><CopyrightInformation>Copyright © 2020 by The Korean Society of Infectious Diseases, Korean Society for Antimicrobial Therapy, and The Korean Society for AIDS.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Choongman</ForeName><Initials>C</Initials><Identifier Source="ORCID">https://orcid.org/0000-0003-1521-4493</Identifier><AffiliationInfo><Affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ahn</LastName><ForeName>Mi Young</ForeName><Initials>MY</Initials><Identifier Source="ORCID">https://orcid.org/0000-0002-7312-8502</Identifier><AffiliationInfo><Affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Byeon</LastName><ForeName>Kyeongmin</ForeName><Initials>K</Initials><Identifier Source="ORCID">https://orcid.org/0000-0001-9037-381X</Identifier><AffiliationInfo><Affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Choi</LastName><ForeName>Jae Phil</ForeName><Initials>JP</Initials><Identifier Source="ORCID">https://orcid.org/0000-0003-4805-7930</Identifier><AffiliationInfo><Affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hahm</LastName><ForeName>Chorom</ForeName><Initials>C</Initials><Identifier Source="ORCID">https://orcid.org/0000-0002-6027-2185</Identifier><AffiliationInfo><Affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Hyeonmok</ForeName><Initials>H</Initials><Identifier Source="ORCID">https://orcid.org/0000-0002-1756-8300</Identifier><AffiliationInfo><Affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Suhyun</ForeName><Initials>S</Initials><Identifier Source="ORCID">https://orcid.org/0000-0002-7802-5967</Identifier><AffiliationInfo><Affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Tae Ho</ForeName><Initials>TH</Initials><Identifier Source="ORCID">https://orcid.org/0000-0002-3720-8011</Identifier><AffiliationInfo><Affiliation>Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author 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DateType="Electronic"><Year>2020</Year><Month>07</Month><Day>23</Day></ArticleDate></Article><MedlineJournalInfo><Country>Korea (South)</Country><MedlineTA>Infect Chemother</MedlineTA><NlmUniqueID>101531537</NlmUniqueID><ISSNLinking>1598-8112</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">Coronavirus disease 2019</Keyword><Keyword MajorTopicYN="N">Pneumonia</Keyword><Keyword MajorTopicYN="N">Remdesivir</Keyword><Keyword MajorTopicYN="N">Severe acute respiratory syndrome coronavirus 2</Keyword></KeywordList><CoiStatement>DHO, MYA, KB, JC, CH, HK, SK, THK, and JO received research grants from Gilead Sciences.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>06</Month><Day>29</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>07</Month><Day>05</Day></PubMedPubDate><PubMedPubDate 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