At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 160 enrolled
Drug / intervention
rNAPc2 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19)
In Brief
A Phase 3 clinical trial evaluating rNAPc2 and Heparin for Covid19. Completed, enrolled 160 participants across 24 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesArgentina, Brazil, United States
CollaboratorsColorado Prevention Center
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartDec 2020
Primary CompletionDec 2021
Study CompletionMar 2022
TodayJul 2026
First PostedDec 7, 2020
Enrollment StartDec 10, 2020
Primary CompletionDec 6, 2021
Study CompletionMar 7, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.6 years ago
Interventions
rNAPc2drug
two dose levels of rNAPc2
Heparindrug
standard of care heparin per institution (therapeutic or prophylactic regimen)