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

NCT04655586 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-02-21

Study results available
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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.

Conditions

  • Covid19

Interventions

DRUG

rNAPc2

two dose levels of rNAPc2

DRUG

Heparin

standard of care heparin per institution (therapeutic or prophylactic regimen)

Sponsors & Collaborators

  • Colorado Prevention Center

    collaborator OTHER

  • ARCA Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Marc Bonaca, MD, MPH · CPC Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2021-12-06
Completion
2022-03-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04655586 on ClinicalTrials.gov