Evaluated rNAPc2 as a potential treatment for severe COVID-19
Phase 2b Clinical Trial
ASPEN-COVID-19 topline results reported March 2022
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 was 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 had an elevated D-dimer level. The primary endpoint of the trial was 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.