Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) (IMPACT)

August 24, 2023 updated by: Weill Medical College of Cornell University

InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial)

The purpose of this study is to determine if therapeutic dose anticoagulation (experimental group) improves 30-day mortality in participants with COVID-19 compared to those patients receiving the intermediate dose prophylaxis (control group). Following screening, subjects will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11215
        • New York Presbyterian Brooklyn Methodist Hospital
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years old
  • COVID-19 positive on (RT-PCR) nasopharyngeal swab, or suspected COVID-19 infection with detectable SARS-CoV-2 IgG or IgM.
  • Intensive care unit (ICU) patient or non-ICU patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula.
  • D dimer level greater than 700 ng/mL (3 times the upper limit of normal).

Exclusion Criteria:

  • Objectively documented deep vein thrombosis or pulmonary embolism
  • Patients in whom there is very high suspicion for pulmonary embolism and are on full-dose anticoagulation as per the treating physician
  • Platelets <30,000 not due to disseminated intravascular coagulation (DIC), based on the International Society of Thrombosis and Haemostasis (ISTH) criteria and American Society of Hematology (ASH) Frequently Asked Questions
  • Active bleeding that poses a contraindication to therapeutic anticoagulation in the opinion of the investigator.
  • History of bleeding diathesis (e.g., hemophilia, severe von Willebrand disease, severe thrombocytopathy)
  • History of intracranial hemorrhage in the last 90 days
  • History of ischemic stroke in the past 2 weeks
  • Major neurosurgical procedure in the past 30 days
  • Cardiothoracic surgery in the past 30 days
  • Intra-abdominal surgery in the past 30 days
  • Intracranial malignancy
  • Patients who require therapeutic anticoagulation for other reasons like atrial fibrillation, deep venous thrombosis, pulmonary embolism, or antiphospholipid syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intermediate Dose Prophylaxis

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
Drug: Enoxaparin sodium

Intermediate Dose Prophylaxis Arm:

0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min

Therapeutic Dose Anticoagulation Arm:

1 mg/kg subcutaneously every 12 hours

Other Names:
  • Lovenox
Drug: Unfractionated heparin

Intermediate Dose Prophylaxis Arm:

7,500 units subcutaneously every 8 hours

Therapeutic Dose Anticoagulation Arm:

Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol

Other Names:
  • Sodium heparin
Drug: Fondapariniux

Intermediate Dose Prophylaxis Arm:

2.5 mg daily subcutaneously

Therapeutic Dose Anticoagulation Arm:

Dose by weight:

  • If greater than or equal to 100 kg: 10 mg daily
  • If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
  • If less than 50 kg: 5 mg daily
Other Names:
  • Arixtra
Experimental: Therapeutic Dose Anticoagulation

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
Drug: Enoxaparin sodium

Intermediate Dose Prophylaxis Arm:

0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min

Therapeutic Dose Anticoagulation Arm:

1 mg/kg subcutaneously every 12 hours

Other Names:
  • Lovenox
Drug: Unfractionated heparin

Intermediate Dose Prophylaxis Arm:

7,500 units subcutaneously every 8 hours

Therapeutic Dose Anticoagulation Arm:

Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol

Other Names:
  • Sodium heparin
Drug: Fondapariniux

Intermediate Dose Prophylaxis Arm:

2.5 mg daily subcutaneously

Therapeutic Dose Anticoagulation Arm:

Dose by weight:

  • If greater than or equal to 100 kg: 10 mg daily
  • If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
  • If less than 50 kg: 5 mg daily
Other Names:
  • Arixtra
Drug: Argatroban

Therapeutic Dose Anticoagulation Arm:

Dosed according to institutional protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Mortality
Time Frame: 30 days
Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Intensive Care Unit (ICU) Stay in Days
Time Frame: 6 months
Comparison of length of ICU stay in days between each treatment arm.
6 months
Number of Documented Venous Thromboembolism (VTE), Arterial Thrombosis (Stroke, Myocardial Infarction, Other) and Microthrombosis Events
Time Frame: 6 months
Comparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm
6 months
Number of Major and Clinically Relevant Non-major Bleeding Events
Time Frame: 6 months
Comparison of major and clinically-relevant non-major bleeding events on each treatment arm, as defined by the International Society of Thrombosis and Haemostasis (ISTH) criteria.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Maria T DeSancho, MD, MSc, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Actual)

April 17, 2021

Study Completion (Actual)

April 21, 2022

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-04021936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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