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Clinical trial

Hamburg Edoxaban for Anticoagulation in COVID-19 Study

ID
Name
HERO-19
Description
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.
Trial arms
Trial start
2020-11-12
Estimated PCD
2022-09-06
Trial end
2023-01-15
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
Intensive anticoagulation strategy
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
Arms:
Moderate anticoagulation strategy
Size
140
Primary endpoint
Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism
42 days
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ACTUAL'}}
Updated at
2023-05-23

1 organization

2 products

1 indication

Organization
Universitätsklinikum Hamburg-Eppendorf
Product
Anticoagulation Agents (Edoxaban and/or high dose LMWH)
Indication
COVID-19
Product
Low molecular weight heparin