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FXIa Inhibitor
Active for Coronavirus
Phase 2
Waitlist Available
Research Sponsored by eXIthera Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after discharge
Awards & highlights
Study Summary
This triallooks at how a drug (Frunexian) can help treat COVID-19 in seriously ill patients. It will monitor those in ICU until they are discharged from the hospital.
Eligible Conditions
- Coronavirus
- Low Platelet Count
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ActiveExperimental Treatment1 Intervention
Frunexian infusion 0.6 mg/kg/hr or 1 mg/kg/hr. 0.6 mg/kg/hr dose will be completed first.
Group II: Institutional StandardActive Control1 Intervention
Clinician's choice of prophylaxis strategy
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Who is running the clinical trial?
eXIthera PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
Charles V. Pollack, Jr.,, MA, MDStudy DirectorDepartment of Emergency Medicine, University of Mississippi School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are using pneumatic compression devices to prevent blood clots.You have had a bleeding in your brain or stomach that required hospitalization or blood transfusion in the last 3 months.Patients who are very sick and not expected to live for another day.You are already participating in other studies that involve medication for blood thinning or platelet control.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Institutional Standard
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies remaining in this experiment for participants?
"Unfortunately, according to clinicaltrials.gov this medical study is no longer recruiting patients - the trial was initially posted on November 1st 2022 and last updated on October 25th 2022. Nonetheless, there are currently 1155 other trials open for recruitment across the globe."
Answered by AI
What risks do patients face when adhering to the established Institutional Standard?
"Based on our assessment, the safety of Institutional Standard was given a score of 2 since it is currently at Phase 2 trials. While there are some data sets proving its safety, none have been provided to show efficacy."
Answered by AI
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