drugset / Trial / NCT05040776

COVID-19 ThromboprophylaXIs Study of Novel FXIa Inhibitor Frunexian (EP-7041) in ICU Patients

NCT05040776 ↗

Phase 2 Withdrawn eXIthera Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject FRUNEXIAN Small molecule 0.6 mg/kg Intravenous
Subject FRUNEXIAN Small molecule 1 mg/kg Intravenous