A Phase II Study of DAS181, a Novel Host Directed Antiviral for the Treatment of Influenza Infection
A Phase II Study of DAS181, a Novel Host Directed Antiviral for the Treatment of Influenza Infection
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DOI：
10.1093/infdis/jis622
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发表时间：
2012-12-15
影响因子：
6.4
通讯作者：
Steigbigel, Roy T.
中科院分区：
文献类型：
--
作者：
Moss, Ronald B.;Hansen, Carrie;Steigbigel, Roy T.
背景DAS 181是一种正在开发用于流感治疗的新型宿主定向抗病毒药物，在该II期临床试验中进行了评估。本研究是一项双盲、安慰剂对照的II期临床试验，评估健康流感感染受试者的流感病毒载量和患者安全性。参与者被随机分为单剂量、多剂量或安慰剂组，并随访安全性和病毒学结果。共有177名实验室确诊的流感感染受试者入组该试验，该试验涵盖了北方和南半球2009-2011年的3个流感季节。37%的参与者确认感染了B型流感，33%感染了季节性H3 N2，29%感染了2009年H1N1大流行，1名参与者对B型流感和2009年H1N1大流行均呈阳性。通过定量聚合酶链反应测定，与安慰剂组相比，多次给药组的病毒载量和病毒脱落较基线变化减少，
Background. DAS181, a novel host-directed antiviral in development for influenza treatment, was assessed in this phase II clinical trial.Methods. This study was a double-blind, placebo-controlled phase II clinical trial assessing influenza viral load and patient safety in otherwise healthy influenza-infected participants. Participants were randomized to a single-dose, multiple-dose, or placebo group and were followed for safety and virologic outcomes.Results. A total of 177 laboratory-confirmed influenza-infected participants were enrolled in the trial, which encompassed 3 influenza seasons from 2009-2011 in both the Northern and Southern Hemispheres. Thirty-seven percent of participants had confirmed infection with influenza B, 33% with seasonal H3N2, 29% with pandemic 2009 H1N1, and 1 participant was positive for both influenza B and pandemic 2009 H1N1. Significant effects were observed in regard to decreased change from baseline viral load and viral shedding in the multiple-dose group compared with placebo as measured by quantitative polymerase chain reaction (P