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

NCT05040776 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 2020-eXIthera-Prophy-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Thrombopenia; Covid19

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Identify the appropriate dose of EP-7041 that demonstrates safety as defined by incidence of treatment-emergent adverse events

  30 days after discharge

Study Arms (2)

Active

OTHER

Frunexian infusion 0.6 mg/kg/hr or 1 mg/kg/hr. 0.6 mg/kg/hr dose will be completed first.

Drug: EP-7041 Injection

Institutional Standard

ACTIVE COMPARATOR

Clinician's choice of prophylaxis strategy

Drug: EP-7041 Injection

Interventions

EP-7041 Injection DRUG

EP-7041 infusion

Also known as: EP-7041, Frunexian

Active; Institutional Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SARS-CoV-2 test (by local evaluation) positive
• Symptom severity and general risk of decompensation warrants, in the opinion of the treating clinician, admission to/care in an intensive care unit setting
• Patient or legally authorized representative (LAR) able and willing to provide written informed consent
• No contraindication to receiving anticoagulation
• At least one D-dimer value ≥2 times local ULN (within 72 hours of hospital admission)

You may not qualify if:

• Moribund patient not expected to survive 24 hours
• ICU length of stay \> 24 hours prior to initiation of frunexian infusion
• Existing venous thromboembolism
• Known immune compromise (HIV/AIDS, chemotherapy, chronic corticosteroid therapy, transplant patient, etc.)
• Active cancer diagnosis
• Pregnant, lactating, or parturient woman
• bodyweight \<40kg
• hemoglobin \<8.0 g/L in the last 72 hours
• platelet count \<50 x 109/L in the last 72 hours
• known fibrinogen \<1.5 g/L (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation)
• known INR \>1.8 (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation)
• patient already on therapeutic anticoagulation at the time of screening (low or high dose nomogram UFH, LMWH, warfarin, or any regular dose of a direct oral anticoagulant)
• patient on dual antiplatelet therapy, when at least one of the agents cannot be stopped safely
• history of spontaneous intracranial bleeding; gastrointestinal bleeding requiring hospitalization and/or transfusion within prior 3 months
• major surgery within prior 30 days

Sponsors & Collaborators

• eXIthera Pharmaceuticals: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Thrombocytopenia; COVID-19

Interventions

(2S,3R)-3-((2-aminopyridin-4-yl)methyl)-1-(((1R)-1-cyclohexylethyl) carbamoyl)-4-oxoazetidine-2-carboxylic acid

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Charles V. Pollack, Jr.,, MA, MD

  Department of Emergency Medicine, University of Mississippi School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Open Label, Single Dose Escalation Study

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 10, 2021
• Study Start: October 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)