About: Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial

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About: Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	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	Assiri, Abdullah Balkhy, Hanan Fowler, Robert Al Bshabshe, Ali Al Harbi, Shmeylan Al Jeraisy, Majed Al-Dawood, Abdulaziz Al-Hameed, Fahad Almotairi, Abdullah Alothman, Adel Jose, Jesna Kharaba, Ayman Kojan, Suleiman Mandourah, Yasser Memon, Javed Qushmaq, Ismael Shalhoub, Sarah Taha, Yusri Hayden, Frederick Arabi, Yaseen Elzein, Fatehi Aljohani, Sameera Alsaedi, Asim Deeb, Ahmad Hussein, Mohamed Sherbeeni, Nisreen Almekhlafi, Ghaleb Maghrabi, Khalid
Source	Medline; PMC
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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2427-0) contains supplementary material, which is available to authorized users.
has issue date	2018-01-30(xsd:dateTime)
bibo:doi	10.1186/s13063-017-2427-0
bibo:pmid	29382391
has license	cc-by
sha1sum (hex)	01c6ed4b3dee404e4d908af40ab93183b573e9ec
schema:url	https://doi.org/10.1186/s13063-017-2427-0
resource representing a document's title	Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial
has PubMed Central identifier	PMC5791210
has PubMed identifier	29382391
schema:publication	Trials
resource representing a document's body	covid:01c6ed4b3dee404e4d908af40ab93183b573e9ec#body_text
is schema:about of	named entity 'AIM' named entity 'HOSPITAL ADMISSION' named entity 'PLACEBO' named entity 'STANDARD' named entity 'MAY BE' named entity 'RESULTS' named entity 'LOPINAVIR' named entity 'EFFECTIVE' named entity 'RECORDED' named entity 'COMBINATION' named entity 'TREATMENT' named entity 'IN VITRO' named entity 'STUDY' named entity 'IFN' named entity 'PROVIDED' named entity 'CONFIRMED' named entity 'specific' named entity 'randomized clinical trials' named entity 'combination' named entity 'Treatment' named entity 'Middle East Respiratory Syndrome' named entity 'CASE' named entity 'MERS' named entity 'EFFICACY' named entity 'TO INVESTIGATE' named entity 'CORONAVIRUS INFECTION' named entity 'COMPARED' named entity 'ANIMAL STUDIES' named entity 'INTERFERON' named entity 'RITONAVIR' named entity 'MIDDLE EAST RESPIRATORY SYNDROME ' named entity 'TREATMENT' named entity 'INTERFERON' named entity 'LOPINAVIR' named entity 'COMBINATION' named entity 'RANDOMIZED CONTROLLED TRIAL' named entity 'STUDY PROTOCOL' named entity 'BUT' named entity 'SPECIFIC' named entity 'BACKGROUND' named entity 'RECOMBINANT' named entity 'INVESTIGATED' named entity 'MIDDLE EAST RESPIRATORY SYNDROME CORONAVIRUS' named entity 'MORE THAN 5 YEARS' named entity 'SUPPORTIVE CARE' named entity 'TRIAL' named entity 'LABORATORY' named entity 'RANDOMIZED CLINICAL TRIALS' named entity 'SUGGEST' named entity 'PATIENTS' named entity 'recombinant' named entity 'placebo' named entity 'study' named entity 'infection'

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