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.

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.

Keywords: Antiviral; Clinical trial; Coronavirus; Interferon-β1b; Lopinavir/ritonavir; MERS; Protocol; Statistical analysis plan.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Coronavirus Infections / diagnosis
  • Coronavirus Infections / drug therapy*
  • Coronavirus Infections / mortality
  • Coronavirus Infections / virology
  • Data Interpretation, Statistical
  • Double-Blind Method
  • Drug Combinations
  • Host-Pathogen Interactions
  • Humans
  • Interferon beta-1b / adverse effects
  • Interferon beta-1b / therapeutic use*
  • Lopinavir / adverse effects
  • Lopinavir / therapeutic use*
  • Middle East Respiratory Syndrome Coronavirus / drug effects*
  • Middle East Respiratory Syndrome Coronavirus / pathogenicity
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Ritonavir / adverse effects
  • Ritonavir / therapeutic use*
  • Saudi Arabia
  • Time Factors
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Drug Combinations
  • lopinavir-ritonavir drug combination
  • Interferon beta-1b
  • Lopinavir
  • Ritonavir

Associated data

  • ClinicalTrials.gov/NCT02845843