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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406389
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Enoxaparin sodium Drug: Unfractionated heparin Drug: Fondapariniux Drug: Argatroban Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial)
Actual Study Start Date : October 13, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Arixtra

Drug: Argatroban

Therapeutic Dose Anticoagulation Arm:

Dosed according to institutional protocol





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406389


Contacts
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Contact: Maria T DeSancho, MD, MSc 646-962-2065 mtd2002@med.cornell.edu
Contact: Marina Loizou 212-746-2190 mal2091@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Maria T DeSancho, MD, MSc    646-962-2065    mtd2002@med.cornell.edu   
Contact: Marina Loizou    212-746-2190    mal2091@med.cornell.edu   
Principal Investigator: Maria T DeSancho, MD, MSc         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Maria T DeSancho, MD, MSc Weill Medical College of Cornell University
Publications:

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04406389    
Other Study ID Numbers: 20-04021936
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Weill Medical College of Cornell University:
COVID-19
Anticoagulation
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Heparin
Calcium heparin
Enoxaparin
Argatroban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors