Stopped: The trial was stopped prematurely due to external evidence that arose during the study period showing that the IMP, baricitinib, was not effective in the primary study population.
EU SolidAct is a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to hospital with COVID-19. The platform is designed for running phase 2 and phase 3 trials, and with modular data capture (end point/safety data, biobanking, add-on studies) depending on the capacity of participating sites. The study consists of two parts with different primary end points depending on disease stage: EU SolidAct part A includes hospitalized patients with moderate disease, whereas EU SolidAct part B includes hospitalized patients with severe and critical disease.
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Occurrence of death within 60 days (primary end point, EU SolidAct part B)
Timeframe: 60 days
Occurrence of disease progression within 14 days (primary end point, EU SolidAct part A)
Timeframe: 14 days
SpO2/FiO2-ratio at day 5 (primary end point, phase 2 trials)
Timeframe: 5 days