安慰剂
医学
耐受性
不利影响
病毒
冠状病毒
内科学
随机对照试验
2019年冠状病毒病(COVID-19)
传输(电信)
严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)
临床试验
病毒学
免疫学
疾病
传染病(医学专业)
病理
电气工程
工程类
替代医学
作者
William A. Fischer,Joseph J. Eron,Wayne Holman,Myron S. Cohen,Lei Fang,Laura J. Szewczyk,Timothy P. Sheahan,Ralph S. Baric,Katie R. Mollan,Cameron R. Wolfe,Elizabeth R. Duke,Masoud M Azizad,Katyna BorrotoiEsoda,David A. Wohl,Amy James Loftis,Paul Alabanza,Felicia Lipansky,Wendy Painter
出处
期刊:Cold Spring Harbor Laboratory - medRxiv
日期:2021-06-17
被引量:77
标识
DOI:10.1101/2021.06.17.21258639
摘要
Abstract Background Easily distributed oral antivirals are urgently needed to treat coronavirus disease-2019 (COVID-19), prevent progression to severe illness, and block transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report the results of a Phase 2a trial evaluating the safety, tolerability, and antiviral efficacy of molnupiravir in the treatment of COVID-19 ( ClinicalTrials.gov NCT04405570 ). Methods Eligible participants included outpatients with confirmed SARS-CoV-2 infection and symptom onset within 7 days. Participants were randomized 1:1 to 200 mg molnupiravir or placebo, or 3:1 to molnupiravir (400 or 800 mg) or placebo, twice-daily for 5 days. Antiviral activity was assessed as time to undetectable levels of viral RNA by reverse transcriptase polymerase chain reaction and time to elimination of infectious virus isolation from nasopharyngeal swabs. Results Among 202 treated participants, virus isolation was significantly lower in participants receiving 800 mg molnupiravir (1.9%) versus placebo (16.7%) at Day 3 (p = 0.02). At Day 5, virus was not isolated from any participants receiving 400 or 800 mg molnupiravir, versus 11.1% of those receiving placebo (p = 0.03). Time to viral RNA clearance was decreased and a greater proportion overall achieved clearance in participants administered 800 mg molnupiravir versus placebo (p = 0.01). Molnupiravir was generally well tolerated, with similar numbers of adverse events across all groups. Conclusions Molnupiravir is the first oral, direct-acting antiviral shown to be highly effective at reducing nasopharyngeal SARS-CoV-2 infectious virus and viral RNA and has a favorable safety and tolerability profile.
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