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

IF 4.7 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials 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
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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).

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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)
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来源期刊
ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
自引率
2.10%
发文量
464
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.
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