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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

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

in Antiretroviral drugs / Antiviral / Antiviral Agents - adverse effects / Antiviral Agents - therapeutic use / Antiviral drugs / Biomedicine / Clinical trial / Clinical trials / Coronavirus / Coronavirus Infections - diagnosis / Coronavirus Infections - drug therapy / Coronavirus Infections - mortality / Coronavirus Infections - virology / Data Interpretation, Statistical / Double-Blind Method / Drug Combinations / Health Sciences / Host-Pathogen Interactions / Humans / Interferon beta-1b - adverse effects / Interferon beta-1b - therapeutic use / Interferon-β1b / Lopinavir - adverse effects / Lopinavir - therapeutic use / Lopinavir/ritonavir / Medicine / Medicine & Public Health / MERS / Middle East respiratory syndrome / Middle East Respiratory Syndrome Coronavirus - drug effects / Middle East Respiratory Syndrome Coronavirus - pathogenicity / Mortality / Multicenter Studies as Topic / Randomized Controlled Trials as Topic / Respiratory diseases / Ritonavir - adverse effects / Ritonavir - therapeutic use / Saudi Arabia / Statistics for Life Sciences / Time Factors / Treatment Outcome / Update

2020

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Journal Article

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

AlJohani, Sameera,

Aziz Jokhdar, Hani A.,

Assiri, Abdullah M.,

Al-Hameed, Fahad,

Balkhy, Hanan H.,

Mandourah, Yasser,

Jose, Jesna,

Al Harthy, Abdulrahman,

Sherbeeni, Nisreen Murad,

Fowler, Robert A.,

Al-Dawood, Abdulaziz,

Al Faraj, Sarah,

Bajhmom, Wail,

Ghazal, Sameeh,

Al Bshabshe, Ali,

Abdelzaher, Mohamed,

Kojan, Suleiman,

Asiri, Ayed Y.,

Al Mekhlafi, Ghaleb A.,

Hayden, Frederick G.,

Alothman, Adel,

Deeb, Ahmad M.,

AlSaedi, Asim,

Elzein, Fatehi Elnour,

Mady, Ahmed,

Almotairi, Abdullah,

Kharaba, Ayman,

Al Sulaiman, Mohammed,

Hussein, Mohamed A.,

Al Harbi, Shmeylan,

Arabi, Yaseen M.,

Al Jeraisy, Majed,

Memish, Ziad A.

2020

Overview

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.

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Publisher

BioMed Central,Springer Nature B.V,BMC

Subject

Antiretroviral drugs

/ Antiviral

/ Antiviral Agents - adverse effects

/ Antiviral Agents - therapeutic use

/ Antiviral drugs

/ Biomedicine

/ Clinical trial