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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 EP-7041 until disposition from the hospital (including post-ICU non-critical care management)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: eXIthera Pharmaceuticals

Criteria

Inclusion Criteria:

• 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

• Patient or legally authorized representative (LAR) able and willing to provide written informed consent

• No contraindication to receiving anticoagulation

• One D-dimer value ≥2 times local ULN (within 72 hours of hospital admission)

Exclusion criteria

Patients who meet ANY of the following criteria are not eligible for inclusion:

• Moribund patient not expected to survive 24 hours

• ICU length of stay > 24 hours prior to initiation of EP-7041 infusion

• Existing venous thromboembolism

• Known immune compromise (HIV/AIDS, chemotherapy, 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

• major surgery within prior 30 days

• known bleeding within the last 30 days requiring emergency department presentation or hospitalization

• known history of a bleeding disorder of an inherited or active acquired bleeding disorder

• recent (<48 hours) or planned spinal or epidural anesthesia or puncture

• anticipated transfer to another hospital that is not a study site within 72 hours

• enrollment in other trials related to anticoagulation or antiplatelet therapy

• use of pneumatic compression devices for thromboprophylaxis

• Failure to meet ALL Inclusion Criteria