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