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.
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.
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
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
UK Aachen
Aachen, Germany
Universitätsklinikum Augsburg
Augsburg, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Freiburg
Freiburg, Germany
Asklepios Klinik Altona
Hamburg, Germany
Asklepios Klinik Barmbek
Hamburg, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Universitärsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
TU München Klinikum rechts der Isar
München, Germany
Stefan Kluge, MD, Principal Investigator
Universitätsklinikum Hamburg-Eppendorf