Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Ubicaciones

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