Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.
Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-017-2427-0
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发表时间：
2018-01-30
期刊：
影响因子：
2.5
通讯作者：
And the MIRACLE trial group
中科院分区：
文献类型：
--
作者：
Arabi YM;Alothman A;Balkhy HH;Al-Dawood A;AlJohani S;Al Harbi S;Kojan S;Al Jeraisy M;Deeb AM;Assiri AM;Al-Hameed F;AlSaedi A;Mandourah Y;Almekhlafi GA;Sherbeeni NM;Elzein FE;Memon J;Taha Y;Almotairi A;Maghrabi KA;Qushmaq I;Al Bshabshe A;Kharaba A;Shalhoub S;Jose J;Fowler RA;Hayden FG;Hussein MA;And the MIRACLE trial group
自第一例中东呼吸综合征冠状病毒感染（MERS-CoV）被记录以来已经超过5年，但在随机临床试验中没有研究过具体的治疗方法。体外和动物研究的结果表明，洛匹那韦/利托那韦和干扰素-β1b（IFN-β1b）的组合可能对MERS-CoV有效。本研究的目的是在需要住院的实验室确诊MERS患者中，研究与安慰剂治疗相比，洛匹那韦/利托那韦和重组IFN-β1b联合治疗并提供标准支持治疗的疗效。本方案根据SPIRIT（标准方案项目：介入试验建议）指南编制。实验室确诊MERS的住院成人患者将入组这项递归、两阶段、成组序贯、多中心、安慰剂对照、双盲随机对照试验。试验最初设计包括2个两阶段组成部分。第一个两阶段组件旨在调整样本量并确定无效停止，但不确定有效停止。第二个两阶段组成部分旨在确定有效性停止和可能的样本量重新调整。主要结局是90天死亡率。这将是第一个关于MERS潜在治疗方法的随机对照试验。这项研究由沙特阿拉伯利雅得的阿卜杜拉国王国际医学研究中心赞助。本研究于2016年11月开始入组，截至2018年1月24日，已入组13例患者。ClinicalTrials.gov，ID：NCT02845843。于2016年7月27日注册。本文的在线版本（doi：10.1186/s13063-017-2427-0）包含补充材料，可供授权用户使用。
It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843. Registered on 27 July 2016. The online version of this article (doi:10.1186/s13063-017-2427-0) contains supplementary material, which is available to authorized users.
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发表时间：
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期刊：
Critical care (London, England)
影响因子：
--
作者：
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