According to BI’s lead investigators, Dr. Lorraine B. Ware, Ralph and Lulu Oven from Vanderbilt University, hope is high that future vaccines will help reduce cases of severe COVID-19, "there remains an unmet need to address respiratory complications in infected patients, and provide healthcare professionals an effective alternative to mechanical ventilation that can potentially reduce the treatment burden within the hospital setting.”
About a third of the 15% of diagnosed COVID-19 patients who develop severe disease are admitted to the intensive care unit (ICU). Approximately, 67 – 85% of this patient group develops ARDS. BI 764198 is designed to reduce severe respiratory distress caused by reactive oxygene species released due to airway injury. According to BI, ROS have been shown to activate TRPC6, which may cause a cascade of cellular damage resulting in disruption of cellular barrier function, hyper-permeability, edema and ultimately acute respiratory distress syndrome (ARDS). BI 764198 treatment in animal models of lung injury has been shown to reduce cellular damage and lung edema.
In the Phase II double-blinded, placebo-controlled trial BI 764198, hospitalised COVID-19 patients will get one dose per day for up to four weeks. The primary endpoint will be the percentage of survivors and patients that do not need mechanical ventilation at day 29. Other endpoints include clinical improvement, oxygen saturation and ICU admission.