CORONA - INFLIXCOVID - Phase 2 study evaluating infliximab in patients with severe COVID-19 progression.

This project aims to make a significant contribution to the management of the COVID-19 crisis. In sepsis, also known as blood poisoning, a dysregulated host response of the body to an infection leads to life-threatening organ failure; this is also the case in severe cases of the disease "Coronavirus Disease-2019 (COVID-19)" caused by the virus SARS-CoV-2. These particularly severe courses with high mortality are characterized in most cases by the development of a pronounced systemic, self-perpetuating inflammatory response. Tumor necrosis factor a (TNF-a) is a signaling molecule of the immune system, a so-called cytokine, which is involved in local and systemic inflammatory reactions and regulates the activity of various immune cells. TNF-a is regularly elevated in severe courses of COVID-19. The overall objective of this project is to evaluate the safety and efficacy of the anti-TNF-a antibody infliximab compared to standard therapy in the treatment of patients with severe COVID-19 disease. It is planned to conduct a so-called randomized, controlled, multicenter, open-label Phase 2 study. COVID-19 patients who are hospitalized and have a defined severe systemic inflammatory response and impaired lung function will be treated with infliximab, a drug already established and approved for other disease entities, by expanding the indication. We hope that by neutralizing TNF-a with infliximab, the strong inflammatory reaction that occurs will be slowed down, the severity of the disease course will be mitigated, and thus the development of sepsis will be prevented. The results of this study could directly influence the therapy of patients with COVID-19 worldwide, as the drug used is already available internationally.