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Fondapariniux for Coronavirus (IMPACT Trial)

Phase 4
Waitlist Available
Led By Maria T DeSancho, MD, MSc
Research Sponsored by Weill Medical College of Cornell University
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 6 months
Awards & highlights

IMPACT Trial Summary

This trial is testing whether a higher dose of anticoagulation medication can improve survival rates for people with COVID-19, compared to a lower dose given for prevention.

Eligible Conditions
  • Coronavirus
  • COVID-19

IMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
30-day Mortality
Secondary outcome measures
Length of Intensive Care Unit (ICU) Stay in Days
Number of Documented Venous Thromboembolism (VTE), Arterial Thrombosis (Stroke, Myocardial Infarction, Other) and Microthrombosis Events
Number of Major and Clinically Relevant Non-major Bleeding Events

IMPACT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Therapeutic Dose AnticoagulationExperimental Treatment4 Interventions
Subjects will receive one of the following interventions, at their physician's discretion: Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol). Enoxaparin 1 mg/kg subcutaneously every 12 hours Argatroban (if heparin-induced thrombocytopenia [HIT]), dosed according to institutional protocol. Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight: ≥100 kg: 10 mg daily <100 kg but ≥50 kg: 7.5 mg daily <50 kg: 5 mg daily
Group II: Intermediate Dose ProphylaxisActive Control3 Interventions
Subjects will receive one of the following interventions, at their physician's discretion: Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours. Fondaparinux (if history of heparin-inducted thrombocytopenia [HIT]) 2.5 mg daily subcutaneously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enoxaparin
FDA approved
Argatroban
FDA approved
Heparin
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,316,129 Total Patients Enrolled
Maria T DeSancho, MD, MScPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Fondapariniux Clinical Trial Eligibility Overview. Trial Name: NCT04406389 — Phase 4
Coronavirus Research Study Groups: Therapeutic Dose Anticoagulation, Intermediate Dose Prophylaxis
Coronavirus Clinical Trial 2023: Fondapariniux Highlights & Side Effects. Trial Name: NCT04406389 — Phase 4
Fondapariniux 2023 Treatment Timeline for Medical Study. Trial Name: NCT04406389 — Phase 4
~3 spots leftby May 2025
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