Phase 3
Completed N=160
Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19
Source: ClinicalTrials.gov NCT04655586 ↗Enrolled (actual)
160
Serious AEs
46.8%
Results posted
Feb 2023
Primary outcomePrimary: Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b) — 137; 41.4; 34.7 Percent change — p=0.4715
◆ Published Evidence
Emerging
12citations · ~4 / year
Novel Tissue Factor Inhibition for Thromboprophylaxis in COVID-19: Primary Results of the ASPEN-COVID-19 Trial.
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.
Linked Publications
-
Novel Tissue Factor Inhibition for Thromboprophylaxis in COVID-19: Primary Results of the ASPEN-COVID-19 Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b) |
137; 41.4; 34.7 | 0.4715 |
| SECONDARY Proportional Change in D-dimer Level From Baseline to 24 Hours Post-dose (Day 2) and Day 3 (Phase 2b) |
23.9; -0.1; 43.5; 65.8; -2.3; 21.5 | 0.1883 |
| SECONDARY Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b) |
0; 0; 1; 1; 0; 1 | — |
| SECONDARY Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) |
1; 1; 1; 0; 1; 1 | — |
| SECONDARY Change in High Sensitivity C-reactive Protein Laboratory Values From Baseline Through Day 8 (Phase 2b) |
-26.1; 270.9; 12.8 | 1.0 |
| SECONDARY Change in Interleukin-6 Laboratory Values From Baseline Through Day 8 (Phase 2b) |
317.4; 768.1; 8.4 | 0.0254 sig |
| SECONDARY Change in Tissue Factor Laboratory Values From Baseline Through Day 8 (Phase 2b) |
-21.2; -1.8; 23.3 | 0.0535 |
| SECONDARY Change in Antiphospholipid Antibodies Laboratory Values From Baseline Through Day 8 (Anti-Beta 2 Glycoprotein IgG) (Phase 2b) |
-24.04; -274.3; 62.99 | 0.8300 |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years and ≤ 90 years at the Screening assessment
- Weight ≥ 50 kg at randomization
- Hospitalized with a diagnosis of COVID-19 and in need of inpatient medical care
- Positive for SARS-CoV-2 on nasopharyngeal, oropharyngeal or other tissue/body fluid samples by PCR or validated other test of ongoing infection (not an antibody test for prior exposure), within seven (7) days of hospitalization or screening assessment
- D-dimer level > upper limit of normal at screening
- Provided electronic or written informed consent, either personally or through a legally authorized representative (LAR)
- Must agree not to participate in a concurrent interventional study involving anticoagulation or anti-platelet therapy
- Female patients of reproductive or child-bearing potential must be willing to use an effective method of contraception for the duration of the study, and male patients must be willing to use an effective method of contraception to avoid partner pregnancy and abstain from sperm donation for at least 90 days after last dose
Exclusion Criteria
- High bleeding risk, e.g. major surgery within prior 1 month, history of a major bleed while receiving anticoagulation, recent hemorrhagic stroke, current or planned (during current hospitalization) dual anti-platelet therapy, platelet count 3.5 mg/dL (60 umol/L))
- Life expectancy estimated to be < 72 hours based on current clinical condition
- Anticipated hospital discharge or transfer within 5 days based on current clinical condition
- Known anti-phospholipid syndrome
- Unable to receive heparin, e.g. history of heparin-induced thrombocytopenia and thrombosis (HITT)
- Participation in any interventional clinical study with an investigational product within seven (7) days of the Screening assessment or within 5 half-lives of the investigational agent, whichever is longer
Data sourced from ClinicalTrials.gov (NCT04655586) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.