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

  • STATUS
    Recruiting
  • End date
    Mar 23, 2023
  • participants needed
    172
  • sponsor
    Universitätsklinikum Hamburg-Eppendorf
Updated on 23 May 2022

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.

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.

Details
Condition Covid19
Treatment Anticoagulation Agents (Edoxaban and/or high dose LMWH), Low dose Low molecular weight heparin or Placebo
Clinical Study IdentifierNCT04542408
SponsorUniversitätsklinikum Hamburg-Eppendorf
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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
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