Clinical Trials Logo

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

See also
  Status Clinical Trial Phase
Recruiting NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Not yet recruiting NCT05047640 - COVID-19 3rd Dose Vaccine in Transplant Patients Phase 3
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Enrolling by invitation NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Recruiting NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Active, not recruiting NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Not yet recruiting NCT05012826 - Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID N/A
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Recruiting NCT05008003 - Dietary Supplements Vit D, Quercetin and Curcumin Combination for Early Symptoms of COVID-19 N/A
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Recruiting NCT04505774 - Anti-thrombotics for Adults Hospitalized With COVID-19 (ACTIV-4) Phase 4