COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04655586

Marc Bonaca

Jennifer Meriwether, jennifer.meriwether@arcabio.com (PI email not reported)

2020-12-07

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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 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

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

3

ARCA Biopharma, Inc.

18

90

Argentina;Brazil;United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

160

Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b)

None

Phase 2/Phase 3

[{"arm_notes": "Low dose", "treatment_id": 1126, "treatment_name": "Rnapc2", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "High dose", "treatment_id": 1126, "treatment_name": "Rnapc2", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]