Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19.

IF 2.1 4区 医学 Q3 VIROLOGY Future Virology Pub Date : 2023-06-01 Epub Date: 2023-06-23 DOI:10.2217/fvl-2023-0064
Arantxa Horga, Daniel R Kuritzkes, John J Kowalczyk, Keith Pietropaolo, Bruce Belanger, Kai Lin, Kristen Perkins, Janet Hammond
{"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}
引用次数: 2

Abstract

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.

Clinical trial registration: NCT04396106 (ClinicalTrials.gov).

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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
背景:贝尼非布韦是一种新型、口服、非致突变、非致畸的核苷酸类似物,可在体外抑制SARS-CoV-2复制。材料和方法:在医院环境中患有中度COVID-19的成年人按1:1的比例随机分配贝尼非布韦/安慰剂。经中期分析,研究修改为两部分;由于护理标准的发展,B部分的入组人数有限。结果:尽管研究提前结束,未达到主要疗效终点,但贝米非布韦耐受性良好,不会导致全因死亡率。与安慰剂相比,贝尼非布韦治疗导致第2天病毒载量平均变化增加0.61 log10;趋势持续至第8天。两组治疗后出现的不良事件相似;大多数是轻度/中度,与研究药物无关。结论:我们的研究结果表明贝尼非布韦在减缓COVID-19进展方面具有潜在作用。临床试验注册:NCT04396106 (ClinicalTrials.gov)
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
Future Virology
Future Virology 医学-病毒学
CiteScore
4.00
自引率
3.20%
发文量
84
审稿时长
6-12 weeks
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.
期刊最新文献
A review: cellular attachment and entry factors of human tumor-associated viruses Exploration of the cross-immunity between SARS-CoV and SARS-CoV-2 in mice It's time for a booster: here's your 19th dose of Future Virology! Post-COVID-19 symptom burden: treatment with Forsythiae Fructus Conference proceedings from the 26th Bangkok International Symposium on HIV Medicine
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1