Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia
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| Publication Date: | 2024 |
| Other Authors: | , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Article |
| Language: | eng |
| Source: | Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) |
| Download full: | http://hdl.handle.net/10362/176784 |
Summary: | Funding Information: Medical writing and editorial support were provided by Laura Watts, PhD, of Lumanity Communications Inc. (Yardley, Pennsylvania, USA), and were funded by Gilead Sciences. Investigators thank the patients and their families for their participation This work was supported by Gilead Sciences. Publisher Copyright: © The Author(s) 2024. |
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Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 PneumoniaA Randomized Clinical TrialCOVID-19kidney impairmentremdesivirSARS-CoV-2Microbiology (medical)Infectious DiseasesSDG 3 - Good Health and Well-beingFunding Information: Medical writing and editorial support were provided by Laura Watts, PhD, of Lumanity Communications Inc. (Yardley, Pennsylvania, USA), and were funded by Gilead Sciences. Investigators thank the patients and their families for their participation This work was supported by Gilead Sciences. Publisher Copyright: © The Author(s) 2024.Background. Few antiviral therapies have been studied in patients with coronavirus disease 2019 (COVID-19) and kidney impairment. Herein, the efficacy, safety, and pharmacokinetics of remdesivir, its metabolites, and sulfobutylether-β-cyclodextrin excipient were evaluated in hospitalized patients with COVID-19 and severe kidney impairment. Methods. In REDPINE, a phase 3, randomized, double-blind, placebo-controlled study, participants aged ≥12 years hospitalized for COVID-19 pneumonia with acute kidney injury, chronic kidney disease, or kidney failure were randomized 2:1 to receive intravenous remdesivir (200 mg on day 1; 100 mg daily up to day 5) or placebo (enrollment from March 2021 to March 2022). The primary efficacy end point was the composite of the all-cause mortality rate or invasive mechanical ventilation rate through day 29. Safety was evaluated through day 60. Results. Although enrollment concluded early, 243 participants were enrolled and treated (remdesivir, n = 163; placebo, n = 80). At baseline, 90 participants (37.0%) had acute kidney injury (remdesivir, n = 60; placebo, n = 30), 64 (26.3%) had chronic kidney disease (remdesivir, n = 44; placebo, n = 20), and 89 (36.6%) had kidney failure (remdesivir, n = 59; placebo, n = 30); and 31 (12.8%) were vaccinated against COVID-19. Composite all-cause mortality or invasive mechanical ventilation rates through day 29 were 29.4% and 32.5% in the remdesivir and placebo group, respectively (P = .61). Treatment-emergent adverse events were reported in 80.4% for remdesivir versus 77.5% for placebo, and serious adverse events in 50.3% versus 50.0%, respectively. Pharmacokinetic plasma exposure to remdesivir was not affected by kidney function. Conclusions. Although the study was underpowered, no significant difference in efficacy was observed between treatment groups. REDPINE demonstrated that remdesivir is safe in patients with COVID-19 and severe kidney impairment.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNSise, Meghan E.Santos, Jose RamonGoldman, Jason D.Tuttle, Katherine R.Pedro Teixeira, J.Seibert, Allan F.Koullias, YiannisLlewellyn, JoeRegan, SeanZhao, YangHuang, HailinHyland, Robert H.Osinusi, AnuWinter, HelenHumeniuk, RitaHulter, Henry N.Gottlieb, Robert L.Fusco, Dahlene N.Birne, RitaStancampiano, Fernando F.Libertin, Claudia R.Small, Catherine B.Plate, MarkusMcPhail, Mark J.2024-12-27T21:31:05Z2024-11-152024-11-15T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article10application/pdfhttp://hdl.handle.net/10362/176784eng1058-4838PURE: 104906557https://doi.org/10.1093/cid/ciae333info:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2025-01-13T01:44:03Zoai:run.unl.pt:10362/176784Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-28T19:20:34.782221Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse |
| dc.title.none.fl_str_mv |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia A Randomized Clinical Trial |
| title |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| spellingShingle |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia Sise, Meghan E. COVID-19 kidney impairment remdesivir SARS-CoV-2 Microbiology (medical) Infectious Diseases SDG 3 - Good Health and Well-being |
| title_short |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| title_full |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| title_fullStr |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| title_full_unstemmed |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| title_sort |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| author |
Sise, Meghan E. |
| author_facet |
Sise, Meghan E. Santos, Jose Ramon Goldman, Jason D. Tuttle, Katherine R. Pedro Teixeira, J. Seibert, Allan F. Koullias, Yiannis Llewellyn, Joe Regan, Sean Zhao, Yang Huang, Hailin Hyland, Robert H. Osinusi, Anu Winter, Helen Humeniuk, Rita Hulter, Henry N. Gottlieb, Robert L. Fusco, Dahlene N. Birne, Rita Stancampiano, Fernando F. Libertin, Claudia R. Small, Catherine B. Plate, Markus McPhail, Mark J. |
| author_role |
author |
| author2 |
Santos, Jose Ramon Goldman, Jason D. Tuttle, Katherine R. Pedro Teixeira, J. Seibert, Allan F. Koullias, Yiannis Llewellyn, Joe Regan, Sean Zhao, Yang Huang, Hailin Hyland, Robert H. Osinusi, Anu Winter, Helen Humeniuk, Rita Hulter, Henry N. Gottlieb, Robert L. Fusco, Dahlene N. Birne, Rita Stancampiano, Fernando F. Libertin, Claudia R. Small, Catherine B. Plate, Markus McPhail, Mark J. |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) RUN |
| dc.contributor.author.fl_str_mv |
Sise, Meghan E. Santos, Jose Ramon Goldman, Jason D. Tuttle, Katherine R. Pedro Teixeira, J. Seibert, Allan F. Koullias, Yiannis Llewellyn, Joe Regan, Sean Zhao, Yang Huang, Hailin Hyland, Robert H. Osinusi, Anu Winter, Helen Humeniuk, Rita Hulter, Henry N. Gottlieb, Robert L. Fusco, Dahlene N. Birne, Rita Stancampiano, Fernando F. Libertin, Claudia R. Small, Catherine B. Plate, Markus McPhail, Mark J. |
| dc.subject.por.fl_str_mv |
COVID-19 kidney impairment remdesivir SARS-CoV-2 Microbiology (medical) Infectious Diseases SDG 3 - Good Health and Well-being |
| topic |
COVID-19 kidney impairment remdesivir SARS-CoV-2 Microbiology (medical) Infectious Diseases SDG 3 - Good Health and Well-being |
| description |
Funding Information: Medical writing and editorial support were provided by Laura Watts, PhD, of Lumanity Communications Inc. (Yardley, Pennsylvania, USA), and were funded by Gilead Sciences. Investigators thank the patients and their families for their participation This work was supported by Gilead Sciences. Publisher Copyright: © The Author(s) 2024. |
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2024 |
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2024-12-27T21:31:05Z 2024-11-15 2024-11-15T00:00:00Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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http://hdl.handle.net/10362/176784 |
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http://hdl.handle.net/10362/176784 |
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eng |
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eng |
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1058-4838 PURE: 104906557 https://doi.org/10.1093/cid/ciae333 |
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