Details

Autor(en) / Beteiligte

• 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 Murad
• Elzein, Fatehi Elnour
• 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

Titel

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

Ist Teil von

• Trials, 2020-01, Vol.21 (1), p.8-8, Article 8

Ort / Verlag

England: BioMed Central

Erscheinungsjahr

2020

Link zum Volltext

Quelle

SpringerLink

Beschreibungen/Notizen

• 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.