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Clinical Trial 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)


Clinical Trial Description

The goal of the COVID-ThromboprophylaXIs Study is to determine the safety and tolerability of two doses of 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 EP-7041 for the first 30 patients enrolled will be randomized 1:1 to 0.6 mg/kg/hr IV (n=15) or 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 EP-7041 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 EP-7041 dose of 0.6 mg/kg/hr. The second phase of the study will enroll 60 additional patients, with 40 in the EP-7041 dosing arm, and 20 in the standard care arm. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05040776
Study type Interventional
Source eXIthera Pharmaceuticals
Contact eXithera Pharmaceuticals
Phone (508) 983-1436
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date December 2021
Completion date December 2023

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