Biotest Aktiengesellschaft announced that the first patients with COVID-19 were treated in the TRICOVID (TRImodulin against COVID-19) trial. This multinational phase III clinical trial plans to enrol more than 330 adult hospitalized patients with moderate or severe COVID-19. These are patients with signs of early systemic inflammation admitted to hospital and requiring supplemental oxygen due to the severity of their disease.

The trial will be conducted in Germany and up to 20 countries worldwide. After confirmation of SARS-CoV-2 infection, the patients will be treated either with trimodulin or with placebo as add-on therapy to standard of care. The clinical concept of this prospective, double-blind, placebo-controlled phase III trial, was developed based on positive results from the phase II trial (ESsCOVID) in a subgroup of patients with early systemic inflammation and after the German Authority (Paul-Ehrlich- Institute) confirmed that further development is warranted.

Due to these results and the advanced development stage of trimodulin Biotest received substantial funding from the German Federal Ministry of Education and Research for this project (FKZ: 16LW0112) within the framework of the funding programme ‘Promotion of the clinical development of COVID-19 drugs and their manufacturing capacities', in order to facilitate rapid development of additional treatment options for hospitalized patients with COVID-19. Biotest's development product trimodulin is a worldwide unique, innovative polyvalent antibody composition, purified from human plasma. In addition to the clinical development in COVID-19, trimodulin treatment has already demonstrated promising results in a phase II clinical trial (CIGMA) with 160 invasive mechanically ventilated patients suffering from severe community-acquired pneumonia (sCAP).

The phase III trial in sCAP (ESsCAPE) has been already submitted in some countries.