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Eli Lilly Initiates P-III Study Evaluating Baricitinib in Hospitalized Patients with COVID-19

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Eli Lilly Initiates P-III Study Evaluating Baricitinib in Hospitalized Patients with COVID-19

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  • Eli Lilly has reported that the first patient has been enrolled in a P-III study assessing the efficacy and safety of baricitinib (4mg- qd) vs PBO in hospitalized patients with COVID-19 with at least one elevated marker of inflammation but not requiring invasive mechanical ventilation at study entry. The company anticipates enrolling 400 patients with its expected data in the next few months
  • The study will be conducted in the US- EU- and Latin America and includes patients hospitalized with COIVD-19. The 1EPs of study is the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by day 28 while the 2EPs include the proportion of patients with clinical improvement at different time points- time to recovery- duration of hospitalization- number of ventilator-free days and mortality over a 28-day period
  • The results will complement data from the study of baricitinib + remdesivir in the ACTT-2 study- led by NIAID. The study enrolled its first patient last month & assesses the efficacy and safety of the baricitinib + remdesivir (4mg- qd) vs remdesivir

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Ref: Eli Lilly | Image: Eli Lilly

 


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