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
coronavirus, MERS, antiviral, clinical trial, Lopinavir/ritonavir, Interferon-β1b
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.
Yaseen M. Arabi, Ayed Y. Asiri, Abdullah M. Assiri, Hani A. Aziz Jokhdar, Adel Alothman, Hanan H Balkhy, Sameera Al Johani, 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. Almekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Abdullah Almotairi, Ali Al Bshabshe, Ayman Kharaba, Jesna Jose, Abdulrahman AL-Harthy, Mohammed Alsulaiman, Ahmed Mady, Robert A Fowler, Frederick G. Hayden, Abdulaziz Al Dawood, Mohamed Abd Elzaher, Wail Bajhmom, Mohamed A. Hussein, and the Saudi Critical Care Trials group