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.
【저자키워드】 coronavirus, clinical trial, protocol, Lopinavir/ritonavir, Antiviral, MERS, Statistical analysis plan, Interferon-β1b, 【초록키워드】 Randomized controlled trial, Treatment, Efficacy, Mortality, Trial, combination therapy, MERS-CoV, Placebo, multicenter, placebo-controlled, double-blind, Primary outcome, intention-to-treat principle, primary analysis, laboratory-confirmed, standard supportive care, provided, hospitalized patient, 【제목키워드】 Randomized controlled trial, Combination, Middle East, syndrome,