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

• Type of Material: Article
• Authors: Yaseem M. Arabi, King Saud bin Abdulaziz University for Health Sciences; Ayed Y. Asiri, Prince Mohammed Bin Abdulaziz Hospital; Abdullah M. Assiri, Ministry of Health Saudi Arabia; Hani A. Aziz Jokhdar, Ministry of Health 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 Ahmed Memish, Emory University; 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, Prince Sultan Military Medical City; Ghaleb A. Al Mekhlafi, Prince Sultan Military Medical City; Nisreen Murad Sherbeeni, Prince Sultan Military Medical City; Fatehi Elnour Elzein, Prince Sultan Military Medical City; Abdullah Almotairi, King Fahad Medical City
• Language: English
• Date: 2020-01-03
• Publisher: BMC (part of Springer Nature)
• Publication Version: Final Published Version
• Copyright Statement: Copyright © The Author(s). 2020
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s13063-019-3846-x
• Title of Journal or Parent Work: Trials
• ISSN: 1745-6215
• Volume: 21
• Issue: 1
• Start Page: 8
• End Page: 8
• Grant/Funding Information: The MIRACLE trial is funded by King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
• Keywords: MERS; Lopinavir/ritonavir; Statistical analysis plan; Antiviral; Clinical trial; Coronavirus; Interferon-β1b; Protocol
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Public Health; Health Sciences, Pharmacology

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.