NCT04542408.

Study name	Hamburg edoxaban for anticoagulation in COVID‐19 study (HERO‐19)
Methods	Prospective, double‐blind RCT
Participants	Number of participants: 172 Age: ≥ 18 years Gender: male and female Inclusion criteria Diagnosis of COVID‐19 and hospitalisation on ICU Diagnosis of COVID‐19 and hospitalisation on normal ward 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
Interventions	Intervention: therapeutic anticoagulation using LMWH body weight‐adapted during course of hospital stay and oral anticoagulation using edoxaban according to summary of product characteristics (60 mg once a day) after being discharged from hospital/outpatient course Control: prophylactic anticoagulation using LMWH as part of standard of care while inpatient course, and placebo after discharge/outpatient course
Outcomes	Primary outcomes Combined endpoint: all‐cause mortality and/or venous thromboembolism and/or arterial thromboembolism (time frame: 42 days) Secondary outcomes All‐cause mortality (time frame: 42 days) Mortality related to VTE (time frame: 42 days) Mortality related to arterial thromboembolism (time frame: 42 days) Rate of venous and/or arterial thromboembolism (time frame: 42 days) Rate and length of mechanical ventilation (time frame: 42 days) Length of initial stay at ICU after application of IMP (time frame: 42 days) Rehospitalisation (time frame: 42 days) Rate and length of renal replacement therapy (time frame: 42 days) Cardiac arrest/cardiopulmonary resuscitation (time frame: 42 days)
Starting date	12 November 2020
Contact information	s.kluge@uke.de m.karakas@uke.de
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