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

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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

Tracking Information
First Submitted Date  ICMJE May 26, 2020
First Posted Date  ICMJE May 28, 2020
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE October 13, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)
Official Title  ICMJE InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Enoxaparin sodium
    • Drug: Unfractionated heparin
    • Drug: Fondapariniux
  • 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
    Interventions:
    • Drug: Enoxaparin sodium
    • Drug: Unfractionated heparin
    • Drug: Fondapariniux
    • Drug: Argatroban
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2020)		 186
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria T DeSancho, MD, MSc 646-962-2065 mtd2002@med.cornell.edu
Contact: Marina Loizou 212-746-2190 mal2091@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04406389
Other Study ID Numbers  ICMJE 20-04021936
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria T DeSancho, MD, MSc Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP