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

Sponsor
ARCA Biopharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04655586
Collaborator
Colorado Prevention Center (Other)
160
Enrollment
24
Locations
3
Arms
13.3
Actual Duration (Months)
6.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
investigational product compared to active comparatorinvestigational 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 :
Dec 10, 2020
Actual Primary Completion Date :
Dec 6, 2021
Actual Study Completion Date :
Jan 19, 2022

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Proportional change in D-dimer level from Baseline to Day 8, or day of discharge if prior to Day 8 (Phase 2b) [8 days]

      central lab D-dimer results

    2. Number of major or non-major clinically relevant bleeding events within eight (8) days of randomization as compared to heparin (Phase 2b and 3) [8 days]

      clinical events as reported by site

    3. Time to recovery within thirty (30) days of randomization using the ACTT ordinal scale (Phase 3) [30 days]

      scale as assessed by investigator and clinical adjudication committee

    Secondary Outcome Measures

    1. Proportional change in D-dimer level from baseline to 24 hours post-dose (Day 2) and Day 3 (Phase 2b) [3 days]

      central lab D-dimer results

    2. Number of major or non-major clinically relevant bleeding events with rNAPc2 vs. heparin through Day 30 (Phase 2b and 3) [30 days]

      clinical events as reported by site

    3. Number of bleeding events in subjects treated with higher vs. lower dose rNAPc2 through Day 30 (Phase 2b) [30 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) [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) [30 days]

      clinical events as reported by site

    6. Time to all-cause mortality within thirty (30) days of randomization (Phase 3 only) [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 through Day 8 (Phase 2b) [8 days]

      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 through Day 8 (Phase 2b) [8 days]

      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 through Day 8 (Phase 2b) [8 days]

      central lab samples collected per protocol

    10. Composite of death, thrombotic events, organ support, and rehospitalization within thirty (30) days adjudicated as to its relatedness to COVID-19 [30 days]

      adjudicated events reported by site

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 of 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. 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:

    1. 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 <25,000/uL, current therapeutic anticoagulation for a medical indication other than COVID-19, e.g. atrial fibrillation, known thrombosis, hereditary or acquired coagulopathy treated with therapeutic anticoagulation. 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 5 days 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ARCA Investigational Site #119 Fairhope Alabama United States 36532
    2 ARCA Investigational Site #118 Phoenix Arizona United States 85006
    3 ARCA Investigational Site #120 Tucson Arizona United States 85724
    4 ARCA Investigational Site #104 Aurora Colorado United States 80045
    5 ARCA Investigational Site #117 Denver Colorado United States 80204
    6 ARCA Investigational Site #101 Jacksonville Florida United States 32209
    7 ARCA Investigational Site #128 Evanston Illinois United States 60201
    8 ARCA Investigational Site #113 New Orleans Louisiana United States 70121
    9 ARCA Investigational Site #105 Falls Church Virginia United States 22042
    10 ARCA Investigational Site #114 Richmond Virginia United States 23230
    11 ARCA Investigational Site #103 Tacoma Washington United States 98405
    12 ARCA Investigational Site #127 San Nicolás Buenos Aires Argentina
    13 ARCA Investigational Site #130 Rosario Santa Fe Argentina
    14 ARCA Investigational Site #112 Rosario Sante Fe Argentina
    15 ARCA Investigational Site #111 Buenos Aires Argentina
    16 ARCA Investigational Site #115 Caba Argentina
    17 ARCA Investigational Site #126 Cordoba Argentina
    18 ARCA Investigational Site #129 San Miguel de Tucuman Argentina
    19 ARCA Investigational Site #106 San Miguel De Tucumán Argentina
    20 ARCA Investigational Site #125 Campo Grande Mato Grosso Do Sul Brazil
    21 ARCA Investigational Site #124 Braganca Paulista Sao Paolo Brazil
    22 ARCA Investigational Site #122 Sao Jose do Rio Preto Sao Paolo Brazil
    23 ARCA Investigational Site #123 Porto Alegre Brazil
    24 ARCA Investigational Site #121 São Paulo Brazil

    Sponsors and Collaborators

    • ARCA Biopharma, Inc.
    • Colorado Prevention Center

    Investigators

    • Principal Investigator: Marc Bonaca, MD, MPH, CPC Clinical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ARCA Biopharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT04655586
    Other Study ID Numbers:
    • NAPc-201/301
    First Posted:
    Dec 7, 2020
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    COVID-19
    Heparin
    Protein C
    Anticoagulants

    Study Results

    No Results Posted as of May 26, 2022