中东呼吸综合征的洛匹那韦/利托那韦联合干扰素-β1b 治疗（MIRACLE 试验）：递归两阶段分组序贯随机对照试验的统计分析计划。
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.
机构信息
College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Intensive Care Department, Ministry of the National Guard - Health Affairs, ICU 1425, P.O. Box 22490, Riyadh, 11426, Saudi Arabia.
出版信息
Trials. 2020 Jan 3;21(1):8. doi: 10.1186/s13063-019-3846-x.
The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b 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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02845843. Registered on 27 July 2016.
MIRACLE 试验（用洛匹那韦/利托那韦和干扰素-β1b 联合治疗中东呼吸综合征冠状病毒感染）研究了洛匹那韦/利托那韦联合重组干扰素-β1b 联合标准支持治疗与安慰剂联合标准支持治疗在住院的实验室确诊中东呼吸综合征患者中的疗效。MIRACLE 试验是一项递归、两阶段、分组序贯、多中心、安慰剂对照、双盲随机对照试验。本文旨在描述 MIRACLE 试验的统计分析计划。主要结局是 90 天死亡率。主要分析将遵循意向治疗原则。MIRACLE 试验是首个针对中东呼吸综合征治疗的随机对照试验。临床试验注册：ClinicalTrials.gov，NCT02845843。注册于 2016 年 7 月 27 日。
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