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-Reference-Cited by-同舟云学术

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

Published:2020-01-03 Issue:1 Volume:21 Page:
ISSN:1745-6215
Container-title:Trials
language:en
Short-container-title:Trials

Author:

Arabi Yaseen M.^ORCID, ,Asiri Ayed Y.,Assiri Abdullah M.,Aziz Jokhdar Hani A.,Alothman Adel,Balkhy Hanan H.,AlJohani Sameera,Al Harbi Shmeylan,Kojan Suleiman,Al Jeraisy Majed,Deeb Ahmad M.^ORCID,Memish Ziad A.,Ghazal Sameeh,Al Faraj Sarah,Al-Hameed Fahad^ORCID,AlSaedi Asim,Mandourah Yasser,Al Mekhlafi Ghaleb A.,Sherbeeni Nisreen Murad,Elzein Fatehi Elnour,Almotairi Abdullah,Al Bshabshe Ali,Kharaba Ayman,Jose Jesna,Al Harthy Abdulrahman,Al Sulaiman Mohammed,Mady Ahmed,Fowler Robert A.,Hayden Frederick G.,Al-Dawood Abdulaziz,Abdelzaher Mohamed,Bajhmom Wail,Hussein Mohamed A.

Abstract

Abstract 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.

Funder

King Abdullah International Medical Research Center

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1186/s13063-019-3846-x.pdf

Reference17 articles.

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