Arantxa Horga, Daniel R Kuritzkes, John J Kowalczyk, Keith Pietropaolo, Bruce Belanger, Kai Lin, Kristen Perkins, Janet Hammond
{"title":"在患有中度新冠肺炎的医院环境中,贝姆尼福布韦对高危参与者的II期研究","authors":"Arantxa Horga, Daniel R Kuritzkes, John J Kowalczyk, Keith Pietropaolo, Bruce Belanger, Kai Lin, Kristen Perkins, Janet Hammond","doi":"10.2217/fvl-2023-0064","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Bemnifosbuvir, a novel, oral, nonmutagenic, nonteratogenic nucleotide analogue inhibits SARS-CoV-2 replication <i>in vitro</i>.</p><p><strong>Materials & methods: </strong>Adults in hospital settings with moderate COVID-19 were randomized 1:1 bemnifosbuvir/placebo. Study amended to two parts after interim analysis; part B enrollment limited owing to evolving standard of care.</p><p><strong>Results: </strong>Although the study ended early and did not meet the primary efficacy end point, bemnifosbuvir was well tolerated and did not contribute to all-cause mortality. Compared with placebo, bemnifosbuvir treatment resulted in 0.61 log<sub>10</sub> greater viral load mean change on day 2; trend sustained through day 8. Treatment-emergent adverse events were similar in both groups; most were mild/moderate, unrelated to study drug.</p><p><strong>Conclusion: </strong>Our results suggest a potential role for bemnifosbuvir in blunting COVID-19 progression.</p><p><strong>Clinical trial registration: </strong>NCT04396106 (ClinicalTrials.gov).</p>","PeriodicalId":2,"journal":{"name":"ACS Applied Bio Materials","volume":" ","pages":"489-500"},"PeriodicalIF":4.7000,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10308776/pdf/","citationCount":"2","resultStr":"{\"title\":\"Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19.\",\"authors\":\"Arantxa Horga, Daniel R Kuritzkes, John J Kowalczyk, Keith Pietropaolo, Bruce Belanger, Kai Lin, Kristen Perkins, Janet Hammond\",\"doi\":\"10.2217/fvl-2023-0064\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Bemnifosbuvir, a novel, oral, nonmutagenic, nonteratogenic nucleotide analogue inhibits SARS-CoV-2 replication <i>in vitro</i>.</p><p><strong>Materials & methods: </strong>Adults in hospital settings with moderate COVID-19 were randomized 1:1 bemnifosbuvir/placebo. Study amended to two parts after interim analysis; part B enrollment limited owing to evolving standard of care.</p><p><strong>Results: </strong>Although the study ended early and did not meet the primary efficacy end point, bemnifosbuvir was well tolerated and did not contribute to all-cause mortality. Compared with placebo, bemnifosbuvir treatment resulted in 0.61 log<sub>10</sub> greater viral load mean change on day 2; trend sustained through day 8. Treatment-emergent adverse events were similar in both groups; most were mild/moderate, unrelated to study drug.</p><p><strong>Conclusion: </strong>Our results suggest a potential role for bemnifosbuvir in blunting COVID-19 progression.</p><p><strong>Clinical trial registration: </strong>NCT04396106 (ClinicalTrials.gov).</p>\",\"PeriodicalId\":2,\"journal\":{\"name\":\"ACS Applied Bio Materials\",\"volume\":\" \",\"pages\":\"489-500\"},\"PeriodicalIF\":4.7000,\"publicationDate\":\"2023-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10308776/pdf/\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ACS Applied Bio Materials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2217/fvl-2023-0064\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/6/23 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"MATERIALS SCIENCE, BIOMATERIALS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Bio Materials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2217/fvl-2023-0064","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/6/23 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"MATERIALS SCIENCE, BIOMATERIALS","Score":null,"Total":0}
Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19.
Background: Bemnifosbuvir, a novel, oral, nonmutagenic, nonteratogenic nucleotide analogue inhibits SARS-CoV-2 replication in vitro.
Materials & methods: Adults in hospital settings with moderate COVID-19 were randomized 1:1 bemnifosbuvir/placebo. Study amended to two parts after interim analysis; part B enrollment limited owing to evolving standard of care.
Results: Although the study ended early and did not meet the primary efficacy end point, bemnifosbuvir was well tolerated and did not contribute to all-cause mortality. Compared with placebo, bemnifosbuvir treatment resulted in 0.61 log10 greater viral load mean change on day 2; trend sustained through day 8. Treatment-emergent adverse events were similar in both groups; most were mild/moderate, unrelated to study drug.
Conclusion: Our results suggest a potential role for bemnifosbuvir in blunting COVID-19 progression.
期刊介绍:
ACS Applied Bio Materials is an interdisciplinary journal publishing original research covering all aspects of biomaterials and biointerfaces including and beyond the traditional biosensing, biomedical and therapeutic applications.
The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrates knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important bio applications. The journal is specifically interested in work that addresses the relationship between structure and function and assesses the stability and degradation of materials under relevant environmental and biological conditions.