Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019
DC Field | Value | Language |
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dc.contributor.author | Streinu-Cercel, Anca | - |
dc.contributor.author | Sandulescu, Oana | - |
dc.contributor.author | Preotescu, Liliana-Lucia | - |
dc.contributor.author | Kim, Jin Yong | - |
dc.contributor.author | Kim, Yeon-Sook | - |
dc.contributor.author | Cheon, Shinhye | - |
dc.contributor.author | Jang, Young Rock | - |
dc.contributor.author | Lee, Sang Joon | - |
dc.contributor.author | Kim, Sung Hyun | - |
dc.contributor.author | Chang, Ilsung | - |
dc.contributor.author | Suh, Jee Hye | - |
dc.contributor.author | Lee, Seul Gi | - |
dc.contributor.author | Kim, Mi Rim | - |
dc.contributor.author | Chung, Da Rae | - |
dc.contributor.author | Kim, Han Na | - |
dc.contributor.author | Streinu-Cercel, Adrian | - |
dc.contributor.author | Eom, Joong Sik | - |
dc.date.accessioned | 2022-04-12T07:40:05Z | - |
dc.date.available | 2022-04-12T07:40:05Z | - |
dc.date.created | 2022-04-06 | - |
dc.date.issued | 2022-04-01 | - |
dc.identifier.issn | 2328-8957 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/83929 | - |
dc.description.abstract | Background Regdanvimab (CT-P59) is a monoclonal antibody with neutralizing activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report on part 1 of a 2-part randomized, placebo-controlled, double-blind study for patients with mild-to-moderate coronavirus disease 2019 (COVID-19). Methods Outpatients with mild-to-moderate COVID-19 received a single dose of regdanvimab 40 mg/kg (n = 100), regdanvimab 80 mg/kg (n = 103), or placebo (n = 104). The primary end points were time to negative conversion of SARS-CoV-2 from nasopharyngeal swab based on quantitative reverse transcription polymerase chain reaction (RT-qPCR) up to day 28 and time to clinical recovery up to day 14. Secondary end points included the proportion of patients requiring hospitalization, oxygen therapy, or mortality due to COVID-19. Results Median (95% CI) time to negative conversion of RT-qPCR was 12.8 (9.0-12.9) days with regdanvimab 40 mg/kg, 11.9 (8.9-12.9) days with regdanvimab 80 mg/kg, and 12.9 (12.7-13.9) days with placebo. Median (95% CI) time to clinical recovery was 5.3 (4.0-6.8) days with regdanvimab 40 mg/kg, 6.2 (5.5-7.9) days with regdanvimab 80 mg/kg, and 8.8 (6.8-11.6) days with placebo. The proportion (95% CI) of patients requiring hospitalization or oxygen therapy was lower with regdanvimab 40 mg/kg (4.0% [1.6%-9.8%]) and regdanvimab 80 mg/kg (4.9% [2.1%-10.9%]) vs placebo (8.7% [4.6%-15.6%]). No serious treatment-emergent adverse events or deaths occurred. Conclusions Regdanvimab showed a trend toward a minor decrease in time to negative conversion of RT-qPCR results compared with placebo and reduced the need for hospitalization and oxygen therapy in patients with mild-to-moderate COVID-19. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | OXFORD UNIV PRESS INC | - |
dc.relation.isPartOf | OPEN FORUM INFECTIOUS DISEASES | - |
dc.title | Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019 | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000769066200001 | - |
dc.identifier.doi | 10.1093/ofid/ofac053 | - |
dc.identifier.bibliographicCitation | OPEN FORUM INFECTIOUS DISEASES, v.9, no.4 | - |
dc.description.isOpenAccess | N | - |
dc.citation.title | OPEN FORUM INFECTIOUS DISEASES | - |
dc.citation.volume | 9 | - |
dc.citation.number | 4 | - |
dc.contributor.affiliatedAuthor | Eom, Joong Sik | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | COVID-19 | - |
dc.subject.keywordAuthor | CT-P59 | - |
dc.subject.keywordAuthor | regdanvimab | - |
dc.subject.keywordAuthor | SARS-CoV-2 | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalResearchArea | Infectious Diseases | - |
dc.relation.journalResearchArea | Microbiology | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.relation.journalWebOfScienceCategory | Infectious Diseases | - |
dc.relation.journalWebOfScienceCategory | Microbiology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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