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":12505,"journal":{"name":"Future Virology","volume":null,"pages":null},"PeriodicalIF":2.1000,"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\":12505,\"journal\":{\"name\":\"Future Virology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.1000,\"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\":\"Future Virology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2217/fvl-2023-0064\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/6/23 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"VIROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Future Virology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2217/fvl-2023-0064","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/6/23 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"VIROLOGY","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：
Future Virology is a peer-reviewed journal that delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this ever-expanding area of research. It is an interdisciplinary forum for all scientists working in the field today.
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