Journal
TRIALS
Volume 21, Issue 1, Pages -Publisher
BMC
DOI: 10.1186/s13063-019-3846-x
Keywords
Coronavirus; MERS; Antiviral; Clinical trial; Lopinavir; ritonavir; Interferon-beta 1b; Statistical analysis plan; Protocol
Categories
Funding
- King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia
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The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-beta 1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-beta 1b 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.
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