Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN)
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ClinicalTrials.gov Identifier: NCT04655586 |
Recruitment Status :
Recruiting
First Posted : December 7, 2020
Last Update Posted : January 6, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Drug: rNAPc2 Drug: Heparin | Phase 2 Phase 3 |
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 |

Arm | Intervention/treatment |
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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
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Drug: rNAPc2
two dose levels of rNAPc2
Other Names:
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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
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Drug: rNAPc2
two dose levels of rNAPc2
Other Names:
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Active Comparator: Heparin
heparin at either prophylactic or therapeutic doses per Standard of Care at Institution
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Drug: Heparin
standard of care heparin per institution (therapeutic or prophylactic regimen) |
- Change in D-dimer level from Baseline to Day 8 (Phase 2b) [ Time Frame: 8 days ]central lab D-dimer results
- 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
- 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
- Change in D-dimer level from baseline to Day 10 (Phase 2b) [ Time Frame: 10 days ]central lab D-dimer results
- 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
- 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
- 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
- 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
- Time to all-cause mortality within thirty (30) days of randomization (Phase 3 only) [ Time Frame: 30 days ]clinical events as reported by site
- 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
- 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
- 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

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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 |
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 prior to 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
- 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:
- 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.
- Sustained systolic blood pressure < 90 mmHg considered to be clinically significant
- Persistent eGFR <20 ml/min/1.73m2
- Known severe liver disease (e.g. bilirubin >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 72 hours 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 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

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
Contact: Jennifer Meriwether | 720-940-2132 | jennifer.meriwether@arcabio.com |
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 |
Principal Investigator: | Marc Bonaca, MD, MPH | CPC Clinical Research |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
D-dimer Thromboprophylaxis Anti-coagulant Thrombotic Events |
Coagulation Inflammation Heparin |
Heparin Protein C Anticoagulants |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |