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NCT04655586 · ClinicalTrials.gov registry record · Phase 2
Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19
A Phase 2 study, sponsored by ARCA Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT04655586: Completed Phase 2 study, sponsored by ARCA Biopharma.
NCT04655586 is a Phase 2 study that has completed, run by ARCA Biopharma. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04655586, a Phase 2 study, has completed, sponsored by ARCA Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study 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.
Primary Outcome
Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 8 or early discharge - D-Dimer level at baseline) / D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory, i.e. both from central laboratory, or local laboratory paired samples if the central laboratory values are not available.
Interventions
- DRUG Heparin
- DRUG rNAPc2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2022-03-07 |
| Phase | Phase 2 |
What the finished NCT04655586 record still lists
NCT04655586 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Heparin is the first listed.
NCT04655586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04655586 about?
NCT04655586 is a clinical study titled "Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19". 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 hospital...
What is the current status of trial NCT04655586?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2020-12-10. Estimated completion is 2022-03-07.
What interventions are being tested in trial NCT04655586?
The interventions under investigation include: Heparin (DRUG), rNAPc2 (DRUG).
Who is sponsoring clinical trial NCT04655586?
This trial is sponsored by ARCA Biopharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04655586's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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