NCT04655586

Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19

Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: ARCA Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that rNAPc2 (AB201), a novel, potent and highly selective tissue factor inhibitor with anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer levels.

Detailed description

Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that rNAPc2, a novel, potent and highly selective tissue factor inhibitor with anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer levels. Study participants and Clinical Endpoint Committee (CEC) members assessing the clinical endpoints will be blinded to treatment assignment. The protocol comprises sequential Phase 2b and Phase 3 studies. Analysis of Phase 2b data could lead to study discontinuation, adjustment of eligibility criteria or sample size, and will inform the rNAPc2 dose level to be studied in Phase 3.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	rNAPc2	two dose levels of rNAPc2
DRUG	Heparin	standard of care heparin per institution (therapeutic or prophylactic regimen)

Timeline

• Start date: 2020-12-10
• Primary completion: 2021-12-06
• Completion: 2022-03-07
• First posted: 2020-12-07
• Last updated: 2023-02-21
• Results posted: 2023-02-21

Locations

24 sites across 3 countries: United States, Argentina, Brazil

Regulatory

• FDA-regulated drug study