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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04655586
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : January 6, 2021
Sponsor:
Collaborator:
Colorado Prevention Center
Information provided by (Responsible Party):
ARCA Biopharma, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: rNAPc2 Drug: Heparin Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: investigational product compared to active comparator
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participant, clinical events committee members will be blind to treatment assignment. Investigator assessing outcomes will be blinded wherever possible.
Primary Purpose: Treatment
Official Title: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19)
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: rNAPc2 Higher Dose
loading dose of 7.5 μg/kg SC on day 1 followed by 5 μg/kg SC on days 3 and 5
Drug: rNAPc2
two dose levels of rNAPc2
Other Names:
  • AB201
  • Recombinant Nematode Anticoagulant Protein c2

Experimental: rNAPc2 Lower Dose
loading dose of 5 ug/kg SC on day 1 followed by 3 ug/kg SC on days 3 and 5
Drug: rNAPc2
two dose levels of rNAPc2
Other Names:
  • AB201
  • Recombinant Nematode Anticoagulant Protein c2

Active Comparator: Heparin
heparin at either prophylactic or therapeutic doses per Standard of Care at Institution
Drug: Heparin
standard of care heparin per institution (therapeutic or prophylactic regimen)




Primary Outcome Measures :
  1. Change in D-dimer level from Baseline to Day 8 (Phase 2b) [ Time Frame: 8 days ]
    central lab D-dimer results

  2. Number of major or non-major clinically relevant bleeding events within thirty (30) days of randomization (Phase 2b) [ Time Frame: 30 days ]
    clinical events as reported by site

  3. Time to recovery within thirty (30) days of randomization using the ACTT ordinal scale (Phase 3) [ Time Frame: 30 days ]
    scale as assessed by investigator and clinical adjudication committee


Secondary Outcome Measures :
  1. Change in D-dimer level from baseline to Day 10 (Phase 2b) [ Time Frame: 10 days ]
    central lab D-dimer results

  2. Number of major or non-major clinically relevant bleeding events with rNAPc2 vs. heparin (Phase 2b and 3) [ Time Frame: 30 days ]
    clinical events as reported by site

  3. Number of bleeding events in subjects treated with higher vs. lower dose rNAPc2 at Day 10 (Phase 2b) [ Time Frame: 10 days ]
    clinical events as reported by site

  4. Time to first occurrence of a composite of thrombotic events and all-cause mortality within thirty (30) days of randomization (Phase 3 only) [ Time Frame: 30 days ]
    clinical events as reported by site

  5. Time to first occurrence of thrombotic events within thirty (30) days of randomization (Phase 3 only) [ Time Frame: 30 days ]
    clinical events as reported by site

  6. Time to all-cause mortality within thirty (30) days of randomization (Phase 3 only) [ Time Frame: 30 days ]
    clinical events as reported by site

  7. Change in Tissue Factor laboratory values in rNAPc2 treated subjects who had clinical events related to coagulation and inflammation from baseline to Days 8 and 10 (Phase 2b) [ Time Frame: day 8 and day 10 ]
    central lab samples collected per protocol

  8. Change in interleukin-6 laboratory values in rNAPc2 treated subjects who had clinical events related to coagulation and inflammation from baseline to Days 8 and 10 (Phase 2b) [ Time Frame: day 8 and day 10 ]
    central lab samples collected per protocol

  9. Change in high sensitivity C-reactive protein laboratory values in rNAPc2 treated subjects who had clinical events related to coagulation and inflammation from baseline to Days 8 and 10 (Phase 2b) [ Time Frame: day 8 and day 10 ]
    central lab samples collected per protocol



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 90 years at the Screening assessment
  2. Weight ≥ 50 kg at randomization
  3. Hospitalized with a diagnosis of COVID-19 and in need of inpatient medical care
  4. 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 prior to hospitalization or screening assessment
  5. D-dimer level > upper limit of normal at screening
  6. Provided electronic or written informed consent, either personally or through a legally authorized representative (LAR)
  7. Must agree not to participate in a concurrent interventional study involving anticoagulation or anti-platelet therapy
  8. Any woman who suspects she may be pregnant must have a negative pregnancy test prior to randomization. Women of child-bearing potential should agree to avoid pregnancy for 3 weeks following randomization

Exclusion Criteria:

  1. High bleeding risk, e.g. major surgery within prior 1 month, history of a major bleed while receiving anticoagulation, current or planned (during current hospitalization) dual anti-platelet therapy, platelet count <25,000/uL, current anticoagulation for a medical indication. e.g. atrial fibrillation. Patients receiving prophylactic anticoagulation are eligible if they are willing to discontinue current anticoagulation.
  2. Sustained systolic blood pressure < 90 mmHg considered to be clinically significant
  3. Persistent eGFR <20 ml/min/1.73m2
  4. Known severe liver disease (e.g. bilirubin >3.5 mg/dL (60 umol/L))
  5. Life expectancy estimated to be < 72 hours based on current clinical condition
  6. Anticipated hospital discharge or transfer within 72 hours based on current clinical condition
  7. Known anti-phospholipid syndrome
  8. Unable to receive heparin, e.g. history of heparin-induced thrombocytopenia and thrombosis (HITT)
  9. Participation in a clinical study or treatment with an investigational drug or device, defined as one not approved for any indication in the US, Europe or Japan, within seven (7) days of the Screening assessment or within 5 half-lives of the investigational agent, whichever is longer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655586


Contacts
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Contact: Jennifer Meriwether 720-940-2132 jennifer.meriwether@arcabio.com

Locations
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United States, Colorado
ARCA Investigational Site #104 Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
ARCA Investigational Site #101 Recruiting
Jacksonville, Florida, United States, 32209
United States, Washington
ARCA Investigational Site #103 Recruiting
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
ARCA Biopharma, Inc.
Colorado Prevention Center
Investigators
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Principal Investigator: Marc Bonaca, MD, MPH CPC Clinical Research
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Responsible Party: ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT04655586    
Other Study ID Numbers: NAPc-201/301
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ARCA Biopharma, Inc.:
D-dimer
Thromboprophylaxis
Anti-coagulant
Thrombotic Events
Coagulation
Inflammation
Heparin
Additional relevant MeSH terms:
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Heparin
Protein C
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action