Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial
Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial
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DOI：
10.1186/s13063-019-3846-x
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发表时间：
2020-01-03
期刊：
影响因子：
2.5
通讯作者：
Hussein, Mohamed A.
中科院分区：
文献类型：
--
作者：
Arabi, Yaseen M.;Asiri, Ayed Y.;Hussein, Mohamed A.
这项奇迹试验(MERS冠状病毒感染使用洛比那韦/利托那韦和干扰素-β1b的组合治疗)调查了在实验室确认的MERS住院患者中，提供标准支持治疗的洛比那韦/利托那韦和重组干扰素-β1b的联合治疗与提供标准支持治疗的安慰剂的疗效。奇迹试验设计为递归、两阶段、分组序贯、多中心、安慰剂对照、双盲随机对照试验。本文的目的是描述奇迹试验的统计分析方案。主要结果是90天的死亡率。初步分析将遵循意向治疗原则。这项奇迹试验是治疗MERS的第一个随机对照试验。
The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-beta 1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-beta 1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment.