Study Design

Asunercept is being evaluated in an Apogenix-sponsored clinical phase II trial in COVID-19 patients in Russia. The ASUNCTIS trial is a multi-center, randomized, controlled, open-label trial to assess the efficacy and safety of asunercept in patients with severe COVID-19 disease. The plan is to include additional study centers in other European countries, in particular Spain.

The ASUNCTIS trial has four treatment arms to evaluate three different doses of asunercept plus standard of care versus standard of care alone. A total of 400 patients will be recruited, with an equal distribution across all four treatment arms.

The primary endpoint is the time to sustained clinical improvement by at least one category on two consecutive days compared to the status at randomization, measured on the clinical performance scale proposed by the World Health Organization. Secondary endpoints include efficacy according to the National Early Warning Score (NEWS), oxygenation requirement, mechanical ventilation requirement, duration of hospitalization including length of stay in the ICU and percentage of patients admitted to the ICU, and mortality on days 15 and 29.