Hamburg Edoxaban for Anticoagulation in COVID-19 Study

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Treatments: Anticoagulants; Dalteparin; Edoxaban; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

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