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Hamburg Edoxaban for Anticoagulation in COVID-19 Study (HERO-19)

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: NCT04542408
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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Brief Summary:
Hero-19 aims to evaluate if an intensive anticoagulation strategy using Edoxaban on top of standard of care (SOC) of COVID-19 therapy is superior to SOC (in-hospital moderate anticoagulation strategy = low-dose low-molecular weight heparin [LMWH], ambulatory no anticoagulation, i.e. placebo within this trial) in reduction of morbidity and mortality endpoints in patients with COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Anticoagulation Agents (Edoxaban and/or high dose LMWH) Drug: Low dose Low molecular weight heparin or Placebo Phase 3

Detailed Description:
Coagulopathy in the context of COVID-19 is a major threat to affected patients due to deep vein thromboses and pulmonary embolisms. Actual data show an unexpectedly high incidence of partially fatal complications without any prior clinical evidence in some cases. Therefore, this prospective, randomized, assessor-blinded, multicenter, placebo-controlled, interventional trial will investigate whether therapeutic anticoagulation on top of SOC compared to prophylactic anticoagulation as part of SOC- can improve objective patient-relative endpoints, relevant for prognosis in patients with COVID-19. 172 eligible patients will be randomized 1:1 to experimental or control group. Patients enrolled to experimental group will receive therapeutic anticoagulation using LMWH body weight-adapted during course of hospital stay and oral anticoagulation using Edoxaban according to SmPC (60mg once a day) after being discharged from hospital / outpatient course. Patients enrolled to control group will receive prophylactic anticoagulation using LMWH as part of SOC whilst inpatient course, and placebo after discharge / outpatient course. Patients will be informed of their allocation to the placebo group, as it has been shown that the effect of placebo is still detectable.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hamburg Edoxaban for Anticoagulation in COVID-19 Study
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intensive anticoagulation strategy
In-hospital (ICU & normal ward): weight-adapted LMWH, high dose/ therapeutic dose (according to respective SmPC) After discharge and in ambulatory patients: Edoxaban according to SmPC
 Drug: Anticoagulation Agents (Edoxaban and/or high dose LMWH)
In-hospital (ICU & normal ward): weight-adapted LMWH, high dose/ therapeutic dose (according to respective SmPC) After discharge and in ambulatory patients: Edoxaban according to SmPC until
Moderate anticoagulation strategy
In-hospital (ICU & normal ward): LMWH, prophylactic dose as part of SOC After discharge and in ambulatory patients: Administration of oral placebo according to the dosing rules for Edoxaban
 Drug: Low dose Low molecular weight heparin or Placebo
In-hospital (ICU & normal ward): LMWH, prophylactic dose as part of SOC After discharge and in ambulatory patients: Administration of oral pla-cebo according to the dosing rules for Edoxaban


Outcome Measures
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Primary Outcome Measures :
  1. Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism [ Time Frame: 42 days ]
    All-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism during follow-up (42 days). Thromboembolisms will be detected by duplex ultrasonography of arms and legs.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 42 days ]
    All-cause mortality during follow-up (42 days)

  2. Mortality related to venous thromboembolism [ Time Frame: 42 days ]
    Mortality related to venous thromboembolism during follow-up (42 days)

  3. Mortality related to arterial thromboembolism [ Time Frame: 42 days ]
    Mortality related to arterial thromboembolism during follow-up (42 days)

  4. Rate of venous and/ or arterial thromboembolism [ Time Frame: 42 days ]
    Rate of venous and/ or arterial thromboembolism during follow-up (42 days) Thromboembolisms will be detected by duplex ultrasonography of arms and legs

  5. Rate and length of mechanical ventilation [ Time Frame: 42 days ]
    Rate and length of mechanical Ventilation during follow-up (42 days)

  6. Length of initial stay at ICU after application of IMP [ Time Frame: 42 days ]
    Length of initial stay at ICU after application of IMP during follow-up (42 days)

  7. Rehospitalisation [ Time Frame: 42 days ]
    Rehospitalisation during follow-up (42 days)

  8. Rate and length of renal replacement therapy [ Time Frame: 42 days ]
    Rate and length of renal replacement therapy during follow-up (42 days)

  9. Cardiac arrest/ CPR [ Time Frame: 42 days ]
    Cardiac arrest/ CPR during follow-up (42 days)


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Diagnosis of COVID-19 and hospitalization on ICU, or
  • Diagnosis of COVID-19 and hospitalization on normal ward, or
  • Diagnosis of COVID-19 (within 10 days) and troponin ≥ ULN and/or D-dimer ≥0.5 mg/L

Exclusion Criteria:

  • Age below 18
  • Life expectancy less than 3 months before COVID-19
  • Resuscitation > 30 minutes
  • Hypersensitivity to the active substance, to Edoxaban or any of its excipients
  • Significantly increased bleeding risk
  • Other indication for anticoagulation beyond COVID-19
  • GFR < 15 ml/min
  • Planned transfer of the patient to another clinic within the next 42 days
Contacts and Locations
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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): NCT04542408


Contacts
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Contact: Stefan Kluge, MD +49 40 7410 ext 57010 s.kluge@uke.de
Contact: Mahir Karakas, MD +49 152 22817493 m.karakas@uke.de

Locations
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Germany
UK Aachen Recruiting
Aachen, Germany
Contact: Tim-Phillip Simon         
Universitätsklinikum Augsburg Recruiting
Augsburg, Germany
Contact: Elisabeth Schnoy, MD         
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Contact: Bode, MD         
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany
Contact: Hans-Jörg Busch         
Asklepios Klinik Altona Recruiting
Hamburg, Germany
Contact: Dirk Arnold, MD         
Asklepios Klinik Barmbek Recruiting
Hamburg, Germany
Contact: Axel Stang, MD         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany
Contact: Berthold Bein, MD         
Universitärsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany
Contact: Stefan Kluge, MD       s.kluge@uke.de   
Medizinische Hochschule Hannover Recruiting
Hanover, Germany
Contact: Tobias Welte, MD         
TU München Klinikum rechts der Isar Recruiting
München, Germany
Contact: Tobias Lahmer         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Stefan Kluge, MD Universitätsklinikum Hamburg-Eppendorf
More Information
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04542408    
Other Study ID Numbers: HERO-19
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
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
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Coagulopathy
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Heparin
 Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Edoxaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors