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