drugset / Trial / NCT05040776
COVID-19 ThromboprophylaXIs Study of Novel FXIa Inhibitor Frunexian (EP-7041) in ICU Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, open-label, single cohort study of patients with confirmed COVID-19 syndrome who based on clinical judgment require care in an intensive care unit, regardless of whether or not mechanical ventilation is in use or is anticipated. Patients should be enrolled on the first day of the ICU stay; withdrawal of prior thromboprophylaxis, if any, will follow specific protocol guidance. Enrolled patients will thereafter be administered intravenous frunexian (EP-7041) until disposition from the hospital (including post-ICU non-critical care management)
Timeline
- Start
- 2023-10
- Primary completion
- 2024-05
- Completion
- 2025-05
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FRUNEXIAN | Small molecule | 0.6 mg/kg | Intravenous |
| Subject | FRUNEXIAN | Small molecule | 1 mg/kg | Intravenous |