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01-12-2020 | Coronavirus | Update

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

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

Published in: Trials | Issue 1/2020

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.

Available only for authorised users

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Title: 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
Authors: Yaseen M. Arabi
Ayed Y. Asiri
Abdullah M. Assiri
Hani A. Aziz Jokhdar
Adel Alothman
Hanan H. Balkhy
Sameera AlJohani
Shmeylan Al Harbi
Suleiman Kojan
Majed Al Jeraisy
Ahmad M. Deeb
Ziad A. Memish
Sameeh Ghazal
Sarah Al Faraj
Fahad Al-Hameed
Asim AlSaedi
Yasser Mandourah
Ghaleb A. Al Mekhlafi
Nisreen Murad Sherbeeni
Fatehi Elnour Elzein
Abdullah Almotairi
Ali Al Bshabshe
Ayman Kharaba
Jesna Jose
Abdulrahman Al Harthy
Mohammed Al Sulaiman
Ahmed Mady
Robert A. Fowler
Frederick G. Hayden
Abdulaziz Al-Dawood
Mohamed Abdelzaher
Wail Bajhmom
Mohamed A. Hussein
and the Saudi Critical Care Trials group
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Coronavirus
Ritonavir
Middle Eastern Respiratory Syndrome
Interferon
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-019-3846-x

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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

Abstract

Trial registration

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Abstract

Trial registration

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