https://socictopen.socict.org/files/original/0bac1ee415f263af7c7906b9be5640e4.pdf 64b425d28cbb72ad6e64dbf31c488d83 Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Coronavirus Description An account of the resource Dominio científico: Coronavirus Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource 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 Creator An entity primarily responsible for making the resource 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 Description An account of the resource 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. Date A point or period of time associated with an event in the lifecycle of the resource 2020 Subject The topic of the resource coronavirus, MERS, antiviral, clinical trial, Lopinavir/ritonavir, Interferon-β1b Identifier An unambiguous reference to the resource within a given context DOI: 10.1186/s13063-019-3846-x Source A related resource from which the described resource is derived Trials Publisher An entity responsible for making the resource available BMC Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Medicine (General) Language A language of the resource EN