Study Design

Asunercept is being evaluated in an Apogenix-sponsored clinical phase II trial in COVID-19 patients in Spain and 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 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 four hundred 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.

 

 

 

 

Current Status

Patient recrutiment is ongoing in both countries.

 

Study Design

Asunercept is being evaluated as part of an investigator initiated trial (IIT) in patients with COVID-19 sponsored by the Medical University of Vienna. The “Austrian CoronaVirus Adaptive Clinical Trial (ACOVACT)” is a randomized, controlled, multi-center, open-label trial that aims to compare various antiviral treatments for COVID-19.

The asunercept sub-study is a randomized controlled phase II dose-finding trial evaluating three different doses of asunercept plus standard of care versus standard of care alone. It is planned to include up to four hundred patients with moderate to severe COVID-19 disease in a two-stage recruitment process; the final number of patients will be subject to an interim analysis.



The primary endpoint is time to sustained clinical improvement, which is defined as time from randomization to a sustained 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. Further endpoints include oxygenation requirement, viral clearance, duration of hospitalization, and mortality.

 

 

 

Current Status

Patient recrutiment is ongoing.