Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-beta 1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial

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; Saudi Critical Care Trials Grp

doi:10.1186/s13063-019-3846-x

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Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-beta 1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial

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Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-beta 1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial

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, …

Trials, Vol.21(1)

03/01/2020

DOI: https://doi.org/10.1186/s13063-019-3846-x

PMID: 31900204

Abstract

Life Sciences & Biomedicine

Medicine, Research & Experimental

Research & Experimental Medicine

Science & Technology

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.

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Title: Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-beta 1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial
Creators - without role: Yaseen M. Arabi - King Saud bin Abdulaziz University for Health Sciences
Ayed Y. Asiri - Prince Mohammed bin Abdulaziz Hospital
Abdullah M. Assiri - Ministry of Health
Hani A. Aziz Jokhdar - Minist Hlth, Publ Hlth, Riyadh, Saudi Arabia
Adel Alothman - King Saud bin Abdulaziz University for Health Sciences
Hanan H. Balkhy - King Saud bin Abdulaziz University for Health Sciences
Sameera AlJohani - King Saud bin Abdulaziz University for Health Sciences
Shmeylan Al Harbi - King Saud bin Abdulaziz University for Health Sciences
Suleiman Kojan - King Saud bin Abdulaziz University for Health Sciences
Majed Al Jeraisy - King Saud bin Abdulaziz University for Health Sciences
Ahmad M. Deeb - King Saud bin Abdulaziz University for Health Sciences
Ziad A. Memish - Prince Mohammed bin Abdulaziz Hospital
Sameeh Ghazal - Prince Mohammed bin Abdulaziz Hospital
Sarah Al Faraj - Prince Mohammed bin Abdulaziz Hospital
Fahad Al-Hameed - King Saud bin Abdulaziz University for Health Sciences
Asim AlSaedi - King Saud bin Abdulaziz University for Health Sciences
Yasser Mandourah - Riyadh Armed Forces Hospital
Ghaleb A. Al Mekhlafi - Riyadh Armed Forces Hospital
Nisreen Murad Sherbeeni - Riyadh Armed Forces Hospital
Fatehi Elnour Elzein - Riyadh Armed Forces Hospital
Abdullah Almotairi - King Fahd Medical City
Ali Al Bshabshe - Asir Central Hospital
Ayman Kharaba - King Fahad Hospital Jeddah
Jesna Jose - King Abdullah International Medical Research Center
Abdulrahman Al Harthy - King Saud Medical City
Mohammed Al Sulaiman - King Saud Medical City
Ahmed Mady - King Saud Medical City
Robert A. Fowler - University of Toronto
Frederick G. Hayden - University of Virginia
Abdulaziz Al-Dawood - King Saud bin Abdulaziz University for Health Sciences
Mohamed Abdelzaher - King Abdullah Medical City
Wail Bajhmom - King Fahad Hospital Jeddah
Mohamed A. Hussein - National Guard Health Affairs
Saudi Critical Care Trials Grp
Publication Details: Trials, Vol.21(1)
Publisher: Springer Nature
Number of pages: 8
Grant note: King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia
Identifiers: 9913908908331
Academic Unit: Alfaisal University; King Abdulaziz University; King Saud Bin Abdulaziz University for Health Sciences
Language: English
Resource Type: Journal article