Eli Lilly and Co. has initiated a Phase III randomized, double-blind, placebo–controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized COVID-19 patients. Baricitinib, marketed as OLUMIANT, is approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).

Lilly expects to enroll 400 patients in the trial, with data expected in the next few months. The study will be conducted in the U.S., Europe and Latin America and includes patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry.

In COVID-19 infection, increased disease severity can be associated with a hyperinflammatory state. Through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications of this infection. In addition, baricitinib may have a role in inhibiting the host cell proteins that assist in viral reproduction.

The primary endpoint is the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 28 in patients treated with baricitinib compared to placebo.