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

Completed · Phase 2/Phase 3

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04655586

Run by

ARCA Biopharma, Inc.

People needed

160

Starts

2020-12-10

Expected to finish

2022-03-07

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 of 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
• 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

You may not qualify if…

• 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.
• 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 5 days 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 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

Where it is running

• ARCA Investigational Site #119 — Fairhope, Alabama, United States
• ARCA Investigational Site #118 — Phoenix, Arizona, United States
• ARCA Investigational Site #120 — Tucson, Arizona, United States
• ARCA Investigational Site #104 — Aurora, Colorado, United States
• ARCA Investigational Site #117 — Denver, Colorado, United States
• ARCA Investigational Site #101 — Jacksonville, Florida, United States
• ARCA Investigational Site #128 — Evanston, Illinois, United States
• ARCA Investigational Site #113 — New Orleans, Louisiana, United States
• ARCA Investigational Site #105 — Falls Church, Virginia, United States
• ARCA Investigational Site #114 — Richmond, Virginia, United States
• ARCA Investigational Site #103 — Tacoma, Washington, United States
• ARCA Investigational Site #127 — San Nicolás de los Arroyos, Buenos Aires, Argentina
• ARCA Investigational Site #130 — Rosario, Santa Fe Province, Argentina
• ARCA Investigational Site #112 — Rosario, Sante Fe, Argentina
• ARCA Investigational Site #111 — Buenos Aires, Argentina
• ARCA Investigational Site #115 — CABA, Argentina
• ARCA Investigational Site #126 — Córdoba, Argentina
• ARCA Investigational Site #106 — San Miguel de Tucumán, Argentina
• ARCA Investigational Site #129 — San Miguel de Tucumán, Argentina
• ARCA Investigational Site #125 — Campo Grande, Mato Grosso do Sul, Brazil
• ARCA Investigational Site #124 — Bragança Paulista, São Paulo, Brazil
• ARCA Investigational Site #122 — São José do Rio Preto, São Paulo, Brazil
• ARCA Investigational Site #123 — Porto Alegre, Brazil
• ARCA Investigational Site #121 — São Paulo, Brazil

Full record on ClinicalTrials.gov

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