rNAPc2 as a potential treatment for severe COVID-19
Phase 2b Clinical Trial
ASPEN-COVID-19 began enrolling patients in Dec 2020
Topline clinical trial data anticipated Q4 2021
U.S. FDA Fast Track designation granted Nov 2020
Summary of Trial
Assessing Safety, Hospitalization and Efficacy of rNAPc2 in Patients with COVID-19
ASPEN-COVID-19 Phase 2b is a randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin prescribed per local standard of care in approximately 160 hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level. The primary endpoint of the trial is safety and change in D-dimer level from baseline to Day 8 relative to standard of care heparin. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes.