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

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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

Tracking Information
First Submitted Date  ICMJE September 6, 2020
First Posted Date  ICMJE September 9, 2020
Last Update Posted Date May 17, 2022
Actual Study Start Date  ICMJE November 12, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2020)
  • All-cause mortality [ Time Frame: 42 days ]
    All-cause mortality during follow-up (42 days)
  • Mortality related to venous thromboembolism [ Time Frame: 42 days ]
    Mortality related to venous thromboembolism during follow-up (42 days)
  • Mortality related to arterial thromboembolism [ Time Frame: 42 days ]
    Mortality related to arterial thromboembolism during follow-up (42 days)
  • 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
  • Rate and length of mechanical ventilation [ Time Frame: 42 days ]
    Rate and length of mechanical Ventilation during follow-up (42 days)
  • 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)
  • Rehospitalisation [ Time Frame: 42 days ]
    Rehospitalisation during follow-up (42 days)
  • Rate and length of renal replacement therapy [ Time Frame: 42 days ]
    Rate and length of renal replacement therapy during follow-up (42 days)
  • Cardiac arrest/ CPR [ Time Frame: 42 days ]
    Cardiac arrest/ CPR during follow-up (42 days)
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 Hamburg Edoxaban for Anticoagulation in COVID-19 Study
Official Title  ICMJE Hamburg Edoxaban for Anticoagulation in COVID-19 Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Anticoagulation Agents (Edoxaban and/or high dose LMWH)
  • 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
    Intervention: Drug: Low dose Low molecular weight heparin or Placebo
Publications * Not Provided

*   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: September 6, 2020)
172
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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: Stefan Kluge, MD +49 40 7410 ext 57010 s.kluge@uke.de
Contact: Mahir Karakas, MD +49 152 22817493 m.karakas@uke.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04542408
Other Study ID Numbers  ICMJE HERO-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Universitätsklinikum Hamburg-Eppendorf
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Kluge, MD Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date May 2022

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