- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040776
COVID-19 ThromboprophylaXIs Study of Novel FXIa Inhibitor Frunexian (EP-7041) in ICU Patients
October 3, 2023 updated by: eXIthera Pharmaceuticals
Prospective, Open-Label Single Ascending Dose Study of Two Dose Levels of Frunexian (EP-7041), Followed by a Randomized Comparison of One Dose With Institutional Standard Care, for Thromboprophylaxis in Patients Managed in Intensive Care Settings for COVID-19 Syndrome: The COVID-ThromboprophylaXIs Study
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)
Study Overview
Detailed Description
The goal of the COVID-ThromboprophylaXIs Study is to determine the safety and tolerability of two doses of frunexian (EP-7041) for the prevention of thromboembolism in the management of COVID-19 patients, compared to control patients managed with institutional standard care thromboprophylaxis regimens.
Dosing of frunexian for the first 15 patients enrolled will be randomized to 0.6 mg/kg/hr IV (n=15) and next 15 patients will be randomized to 1.0 mg/kg/hr IV (n=15) for the duration of the index hospitalization.
Enrollment will be paused after treatment of these 30 patients, at which time a dedicated DSMB will evaluate all collected safety data through 7 days post-index hospital discharge.
If no adverse safety signal is identified for the 1.0 mg/kg/hr dose, enrollment will be resumed with the study dose of frunexian randomized 2:1 to 1.0 mg/kg/hr or institutional standard care for thromboprophylaxis in ICU patients with COVID-19.
If safety concerns are identified for the higher dose and not for the lower dose, then open-label randomized enrollment vs institutional standard of care for thromboprophylaxis will proceed with an frunexian dose of 0.6 mg/kg/hr.
The second phase of the study will enroll 60 additional patients, with 40 in the frunexian dosing arm, and 20 in the standard care arm.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 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)
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 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Active
Frunexian infusion 0.6 mg/kg/hr or 1 mg/kg/hr.
0.6 mg/kg/hr dose will be completed first.
|
EP-7041 infusion
Other Names:
|
Active Comparator: Institutional Standard
Clinician's choice of prophylaxis strategy
|
EP-7041 infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 30 days after discharge
|
Identify the appropriate dose of EP-7041 that demonstrates safety as defined by incidence of treatment-emergent adverse events
|
30 days after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Charles V. Pollack, Jr.,, MA, MD, Department of Emergency Medicine, University of Mississippi School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
September 7, 2021
First Submitted That Met QC Criteria
September 8, 2021
First Posted (Actual)
September 10, 2021
Study Record Updates
Last Update Posted (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-eXIthera-Prophy-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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