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Preventing COVID-19 Complications With Low- and High-dose Anticoagulation (COVID-HEP)

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: NCT04345848
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Marc Blondon, University Hospital, Geneva

Brief Summary:

The ongoing COVID-19 pandemic affects millions of humans worldwide and has led to thousands of acute medical hospitalizations. There is evidence that hospitalized cases often suffer from an important infection-related coagulopathy and from elevated risks of thrombosis. Anticoagulants may have positive effects here, to reduce the burden of thrombotic disease and the hyperactivity of coagulation, and may also hold beneficial anti-inflammatory effects against sepsis and the development of ARDS.

The investigators hypothesize that high-dose anticoagulants, compared with low-dose anticoagulants, lower the risk of venous and arterial thrombosis, disseminated intravascular coagulation (DIC) and mortality. This open-label controlled trial will randomize hospitalized adults with severe COVID-19 infection to therapeutic anticoagulation vs. thromboprophylaxis during the hospital stay.


Condition or disease Intervention/treatment Phase
COVID Sars-CoV2 Drug: Enoxaparin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Therapeutic anticoagulation
Participants will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or intravenous unfractionated heparin, from admission until the end of hospital stay or clinical recovery.
Drug: Enoxaparin
Two different doses of anticoagulation
Other Name: Unfractionated heparin

Active Comparator: Prophylactic anticoagulation
Participants will be treated with prophylactic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or unfractionated heparin, from admission until the end of hospital stay or clinical recovery. If hospitalized in the intensive care unit, they will receive an augmented thromboprophylaxis regimen as standard of care.
Drug: Enoxaparin
Two different doses of anticoagulation
Other Name: Unfractionated heparin




Primary Outcome Measures :
  1. Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality [ Time Frame: 30 days ]
    Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality


Secondary Outcome Measures :
  1. Arterial thrombosis [ Time Frame: 30 days ]
    Risk of ischemic stroke, myocardial infarction and/or limb ischemia

  2. Venous thromboembolism [ Time Frame: 30 days ]
    Risk of symptomatic venous thromboembolism or asymptomatic proximal leg deep vein thrombosis

  3. Disseminated intravascular coagulation [ Time Frame: 30 days ]
    Risk of DIC

  4. All-cause mortality [ Time Frame: 30 days ]
    Risk of all-cause mortality

  5. Sepsis-induced coagulopathy [ Time Frame: 30 days ]
    Risk of SIC

  6. Acute respiratory distress syndrome [ Time Frame: 30 days ]
    Risk of ARDS

  7. Durations of hospital stay, ICU stay, ventilation [ Time Frame: 30 days ]
    Number of days with these care processes

  8. Sequential organ failure assessment score [ Time Frame: 30 days ]
    Highest score per participant

  9. Clinical deterioration [ Time Frame: 30 days ]
    Risk of clinical deterioration


Other Outcome Measures:
  1. Major bleeding [ Time Frame: 30 days ]
    Risk of ISTH-defined major bleeding

  2. Clinically relevant non-major bleeding [ Time Frame: 30 days ]
    Risk of ISTH-defined CRNMB

  3. Heparin-induced thrombocytopenia [ Time Frame: 30 days ]
    Risk of documented HIT



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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: adult patient with COVID-19 infections, admitted to:

  • an acute non-critical medical ward with admission D-dimer levels >1,000ng/mL, or
  • an acute critical ward (ICU, intermediate care unit)

Exclusion Criteria:

  • ongoing or planned therapeutic anticoagulation for any other indication
  • contra-indication to therapeutic anticoagulation
  • hypersensitivity to heparin
  • personal history of heparin-induced thrombocytopenia
  • suspected or confirmed bacterial endocarditis
  • bleeding events or tendency due to a suspected or confirmed hemostatic bleeding disorder
  • organic lesion prone to bleeding
  • platelet count <50G/L, Hb level <80g/L
  • ongoing or recent (<30 days) major bleeding, ischemic stroke, trauma, surgery
  • use of dual antiplatelet therapy
  • pregnancy
  • bodyweight <40kg or >150kg.
  • end of life care setting
  • unwillingness to consent
  • ongoing participation in a COVID-19 randomized clinical trial testing another therapeutic intervention

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): NCT04345848


Locations
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Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland
Contact: Marc Blondon    +41.22.372.92.92    marc.blondon@hcuge.ch   
Centre Hospitalier Universitaire Vaudois (CHUV) Not yet recruiting
Lausanne, Switzerland
Contact: Lucia Mazzolai         
Ospedale Regionale di Locarno Not yet recruiting
Locarno, Switzerland
Contact: Hans Stricker         
Hôpital du Valais Not yet recruiting
Sion, Switzerland
Contact: Sara Manzocchi-Besson         
Sponsors and Collaborators
University Hospital, Geneva
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marc Blondon, Attending Physician, Angiology, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04345848    
Other Study ID Numbers: 2020-00794
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marc Blondon, University Hospital, Geneva:
anticoagulation
heparin
thrombosis
Additional relevant MeSH terms:
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Heparin
Calcium heparin
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action