Statistical analysis plan for the STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER) study: a randomised, open label, controlled trial in subjects with persistent neurological symptoms after COVID-19 infection
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We outline the statistical análysis plan (SAP) for the STatin TReatment for COVID-19 to Optimise NeuroloGical (STRONGER) study. STRONGER is an international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint (PROBE) study that aims to determine the safety, efficacy and cost-effectiveness of atorvastatin to improve cognitive function, mood, health-related quality of life, and physical function, in adults with a post-COVID-19 neurological syndrome. Participants are randomised (1:1) to either oral 40 mg atorvastatin for a treatment duration of 12 months (intervention group) or not (control group), on top of usual care. The treatment effect on neuroinflammation in the brain will be assessed by changes on magnetic resonance imaging (MRI) and blood biomarkers.The outcome assessments on participants will be completed in July 2025. The trial is registrated at Clinicaltrials.gov ( NCT04904536 ).
