← Back to Search

Fondapariniux for Coronavirus (IMPACT Trial)

Q: Has a similar examination been conducted previously?

As of now, 56 live trials for Unfractionated heparin are taking place across 388 cities and 29 countries. Initially conducted in 2006 by Ash Access Technology to assess the drug's safety, this Phase 3 trial was completed with 415 participants' involvement. Since then, 361 further studies have been launched.

Q: Has Unfractionated heparin been explored in other scientific investigations?

At present, there are 56 ongoing trials for Unfractionated heparin with 19 of them in their final stage. Most clinical tests are being conducted from Nieuwegein, Utrecht; however, trials can be found at 774 locations globally.

Q: How many people have taken part in this research endeavor?

Affirmative. According to clinicaltrials.gov, this trial is still recruiting participants after first being posted on October 13th 2020 and the most recent update taking place July 27th 2022. 186 patients are required at two separate sites.

Q: Does the US Food and Drug Administration recognize Unfractionated heparin as a viable treatment?

Unfractionated heparin is deemed safe and was assigned a score of 3, due to its approval after the completion of Phase 4 clinical trials.

Q: What are Unfractionated heparin's common applications?

Unfractionated heparin is regularly prescribed to treat heparin induced thrombocytopenia (HIT), as well as for prophylaxis of peripheral arterial embolism, acute, superficial, symptomatic vein thrombosis and fracture.

Q: Are enrollees currently being taken in for this medical experiment?

Affirmative. The data housed on clinicaltrials.gov confirms that this trial, which was initially uploaded to the platform in October 2020, is actively recruiting study participants. 186 individuals are required at two different sites for inclusion into the evaluation.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,514 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a similar examination been conducted previously?

"As of now, 56 live trials for Unfractionated heparin are taking place across 388 cities and 29 countries. Initially conducted in 2006 by Ash Access Technology to assess the drug's safety, this Phase 3 trial was completed with 415 participants' involvement. Since then, 361 further studies have been launched."

Answered by AI

Has Unfractionated heparin been explored in other scientific investigations?

"At present, there are 56 ongoing trials for Unfractionated heparin with 19 of them in their final stage. Most clinical tests are being conducted from Nieuwegein, Utrecht; however, trials can be found at 774 locations globally."

Answered by AI

How many people have taken part in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this trial is still recruiting participants after first being posted on October 13th 2020 and the most recent update taking place July 27th 2022. 186 patients are required at two separate sites."

Answered by AI

Does the US Food and Drug Administration recognize Unfractionated heparin as a viable treatment?

"Unfractionated heparin is deemed safe and was assigned a score of 3, due to its approval after the completion of Phase 4 clinical trials."

Answered by AI

What are Unfractionated heparin's common applications?

"Unfractionated heparin is regularly prescribed to treat heparin induced thrombocytopenia (HIT), as well as for prophylaxis of peripheral arterial embolism, acute, superficial, symptomatic vein thrombosis and fracture."

Answered by AI

Are enrollees currently being taken in for this medical experiment?

"Affirmative. The data housed on clinicaltrials.gov confirms that this trial, which was initially uploaded to the platform in October 2020, is actively recruiting study participants. 186 individuals are required at two different sites for inclusion into the evaluation."

Answered by AI

Recent research and studies

Journal of Thrombosis and HaemostasisJournal

Prevalence of Venous Thromboembolism in Patients with Severe Novel Coronavirus Pneumonia

Cui, Songping, Shuo Chen, Xiunan Li, Shi Liu, and Feng Wang. 2020. “Prevalence of Venous Thromboembolism in Patients with Severe Novel Coronavirus Pneumonia”. Journal of Thrombosis and Haemostasis. Wiley. doi:10.1111/jth.14830.

Intensive Care MedicineJournal

High Risk of Thrombosis in Patients with Severe Sars-cov-2 Infection: A Multicenter Prospective Cohort Study

Helms, Julie, CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis), Charles Tacquard, François Severac, Ian Leonard-Lorant, Mickaël Ohana, Xavier Delabranche, et al.. 2020. “High Risk of Thrombosis in Patients with Severe Sars-cov-2 Infection: A Multicenter Prospective Cohort Study”. Intensive Care Medicine. Springer Science and Business Media LLC. doi:10.1007/s00134-020-06062-x.

New England Journal of MedicineJournal

Clinical Characteristics of Covid-19 in New York City

Goyal, Parag, Justin J. Choi, Laura C. Pinheiro, Edward J. Schenck, Ruijun Chen, Assem Jabri, Michael J. Satlin, et al.. 2020. “Clinical Characteristics of Covid-19 in New York City”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmc2010419.

European Heart JournalJournal