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.

Authors

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

Document Type

Article

Publication Date

1-3-2020

Publication Title

Trials

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.

Volume

21

Issue

1

First Page

8

Last Page

8

Recommended Citation

Arabi YM, Asiri AY, Assiri AM, Aziz Jokhdar HA, Alothman A, Balkhy HH, AlJohani S, Al Harbi S, Kojan S, Al Jeraisy M, Deeb AM, Memish ZA, Ghazal S, Al Faraj S, Al-Hameed F, AlSaedi A, Mandourah Y, Al Mekhlafi GA, Sherbeeni NM, Elzein FE, Almotairi A, Al Bshabshe A, Kharaba A, Jose J, Al Harthy A, Al Sulaiman M, Mady A, Fowler RA, Hayden FG, Al-Dawood A, Abdelzaher M, Bajhmom W, Hussein MA; and the Saudi Critical Care Trials group. 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. Trials. 2020 Jan 3;21(1):8. doi: 10.1186/s13063-019-3846-x. PMID: 31900204; PMCID: PMC6942374.

DOI

10.1186/s13063-019-3846-x

ISSN

1745-6215

PubMed ID

31900204