http://socictopen.socict.org/files/original/8d1c2ebb0179a9024b45de7fe6fad5ba.pdf db84bd629e8184538ffaa459c5da2f19 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): study protocol for a randomized controlled trial Creator An entity primarily responsible for making the resource Yaseen M. Arabi, Adel Alothman, Hanan H Balkhy, Abdulaziz Al Dawood, Sameera Al Johani, Shmeylan Al-Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Abdullah M. Assiri, Fahad Al Hameed, Asim AlSaedi, Yasser Mandourah, Ghaleb A. Almekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Javed Memon, Yusri Taha, Abdullah Almotairi, Khalid A. Maghrabi, Ismael Qushmaq, Ali Al Bshabshe, Ayman Kharaba, Sarah Shalhoub, Jesna Jose, Robert A Fowler, Frederick G. Hayden, Mohamed A. Hussein, And the MIRACLE trial group Description An account of the resource Abstract Background It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. Methods The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. Discussion This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. Trial registration ClinicalTrials.gov, ID: NCT02845843. Registered on 27 July 2016. Date A point or period of time associated with an event in the lifecycle of the resource 2018 Subject The topic of the resource coronavirus, MERS, antiviral, Saudi Arabia, clinical trial, Lopinavir/ritonavir Identifier An unambiguous reference to the resource within a given context DOI: 10.1186/s13063-017-2427-0 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