Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience
Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience
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在正在进行的试验中嵌入 COVID-19 组序贯临床试验：不寻常经历的教训
DOI：
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发表时间：
2020
影响因子：
1.8
通讯作者：
S. Zohar
中科院分区：
文献类型：
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作者：
P. Dequin;A. Gouge;E. Tavernier;B. Giraudeau;S. Zohar
Cape-Covid试验是正在进行的Cape-Cod试验中的一项嵌入式临床试验。2019冠状病毒病大流行出现时，我们正在进行一项随机试验，评估皮质类固醇在严重社区获得性肺炎中的有效性。我们利用这项正在进行的试验，嵌入一个子试验，评估氢化可的松在SARS-CoV-2感染患者中的作用。在这份手稿中，我们希望分享我们的经验，当我们需要在两周的时间内在新冠肺炎大流行期间做出快速和稳健的方法决策时。
Abstract The Cape-Covid trial is an embedded clinical trial within the ongoing Cape-Cod trial. The Covid-19 pandemic appeared while we were conducting a randomized trial assessing the effectiveness of corticosteroids in severe community-acquired pneumonia. We took advantage of this ongoing trial to embed a sub-trial assessing hydrocortisone in SARS-CoV-2 infected patients. In this manuscript, we wish to share our experience when we needed to make fast and robust methodological decisions during the Covid-19 pandemic in a two weeks period of time.