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Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients (ETHIC)

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ClinicalTrials.gov Identifier: NCT04492254
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Thrombosis Research Institute

Brief Summary:

Evidence has shown that COVID-19 infections can lead to an increased risk of blood clots. These blood clots can lead to individuals being admitted to hospital, or, unfortunately in severe cases, death. Enoxaparin is a blood-thinning drug which has been used by doctors and nurses in hospitals for many years to prevent the thickening of blood which may lead to a clot. It is easier for doctors to prevent new blood clots from forming than treating existing blood clots.

Currently, there are no treatments for COVID-19. There is an urgent need to find a safe and effective treatment to prevent worsening of the disease that may lead to hospital admission and/or death. The ETHIC (Early Thromboprophylaxis in COVID-19) study aims to find out if giving enoxaparin in an early stage of the COVID-19 disease can prevent individuals being admitted to hospital and/or death. The study will take place in approximately 8 to 10 countries, in approximately 30 to 50 centres.

Patients will be allowed to take part if they have had a confirmed COVID-19 infection, are ≥ 55 years of age and have at least two of the following additional risk factors; age ≥ 70 years, body mass index > 25 kg/m2, chronic obstructive pulmonary disease, diabetes, cardiovascular disease, or corticosteroid use.

Half the patients in the study will receive the blood-thinning drug enoxaparin for three weeks, and half will receive no treatment. Individuals will be randomly allocated to one of these groups. After 21 days, the number of patients in each group who were either admitted to hospital, or died, will be compared. The number of patients in each group who developed a blood clot (venous thromboembolism) will also be compared. Further comparisons will be made at both 50 and 90 days after the beginning of the study.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Enoxaparin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label, multicentre, multi-national, randomized controlled trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Thromboprophylaxis in COVID-19 (ETHIC Trial): an Open Label, Randomized Phase IIIb Trial of Community-based (LMWH) Versus Standard of Care (no Enoxaparin) in COVID-19 Positive Patients
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Enoxaparin
(40 mg o/d if < 100 kg, 40 mg b/d if ≥ 100 kg)
Drug: Enoxaparin
The treatment provided will be enoxaparin sodium 40mg/0.4 mL. All doses will be provided in pre-filled, single-dose syringes for subcutaneous injection.
Other Name: Lovenox/Clexane

No Intervention: Current standard of care (no enoxaparin)
Standard of care



Primary Outcome Measures :
  1. Hospital Admission [ Time Frame: 21 days ]

    Hospital admission including:

    Pneumonia Acute Respiratory distress syndrome Admission to intensive care unit (ICU) Mechanical ventilation (MV)/intubation requirement Continuous positive airway pressure (CPAP)/Non-invasive ventilation Extracorporeal membrane oxygenation (ECMO)


  2. Hospital Admission [ Time Frame: 50 days ]

    Hospital admission including:

    Pneumonia Acute Respiratory distress syndrome Admission to intensive care unit (ICU) Mechanical ventilation (MV)/intubation requirement Continuous positive airway pressure (CPAP)/Non-invasive ventilation Extracorporeal membrane oxygenation (ECMO)


  3. Hospital Admission [ Time Frame: 90 days ]

    Hospital admission including:

    Pneumonia Acute Respiratory distress syndrome Admission to intensive care unit (ICU) Mechanical ventilation (MV)/intubation requirement Continuous positive airway pressure (CPAP)/Non-invasive ventilation Extracorporeal membrane oxygenation (ECMO)


  4. Death [ Time Frame: 21 days ]
    All-cause Cardiovascular Non-Cardiovascular Specific causes Fatal bleed

  5. Death [ Time Frame: 50 days ]
    All-cause Cardiovascular Non-Cardiovascular Specific causes Fatal bleed

  6. Death [ Time Frame: 90 days ]
    All-cause Cardiovascular Non-Cardiovascular Specific causes Fatal bleed


Secondary Outcome Measures :
  1. Bleeding (as defined by ISTH criteria) [ Time Frame: 21 and 50 days ]
    Frequency Location Treatment (transfusion and units of blood products transfused) Severity (classified as major, clinically relevant non-major and minor)

  2. Diagnosis of VTE [ Time Frame: 21, 50 and 90 days ]
    Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed consent
  • Confirmed COVID-19 (i.e. symptoms + positive test for SARS-CoV-2)
  • Male or female, age ≥ 55 years
  • At least two of the following additional risk factors:

Age ≥ 70 years Body mass index > 25 kg/m2 Chronic obstructive pulmonary disease (COPD)* Diabetes* Cardiovascular disease* Corticosteroid use

*Defined as any disease requiring medical intervention or treatment.

Exclusion Criteria:

  • Contraindications to unfractionated heparin or LMWH
  • Recent (<48 hours) or planned spinal or epidural anesthesia or puncture, PCI or thrombolytic therapy within the preceding 24 hours
  • Increased risk for bleeding complications
  • Pregnant women
  • Severe renal impairment (GFR < 30 mL/min)
  • Receiving any antiplatelet therapy (with the exception of low dose (≤100mg) aspirin) or anticoagulant therapy (e.g. VKA, DOAC)
  • Patients participating in an interventional study that is outside the purview of TRI sponsored studies.

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): NCT04492254


Contacts
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Contact: Hilary Vitkus 07795833510 hvitkus@cyteglobal.com

Locations
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Australia
Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital Recruiting
Melbourne, Australia
Principal Investigator: Harry Gibbs         
Belgium
Dr Frank Cools, National Co-ordinating Investigator, AZ Klina Recruiting
Brasschaat, Belgium
Contact: Frank Cools         
South Africa
Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand Recruiting
Johannesburg, South Africa
Contact: Barry Jacobson         
Sponsors and Collaborators
Thrombosis Research Institute
Sanofi
Investigators
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Study Director: Ajay Kakkar Thrombosis Research Institute
Publications:

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Responsible Party: Thrombosis Research Institute
ClinicalTrials.gov Identifier: NCT04492254    
Other Study ID Numbers: TRI-08892
2020-003125-39 ( EudraCT Number )
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Thrombosis Research Institute:
Low Molecular Weight Heparin
Enoxaparin
Additional relevant MeSH terms:
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Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action