Hamburg Edoxaban foR anticoagulation in COvid-19 study

Hamburg Edoxaban foR anticoagulation in COvid-19 study - HERO-19

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002504-39-DE

Enrollment

172

Registered

2020-08-14

Start date

2020-11-10

Completion date

Unknown

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 [Coronavirus disease 2019] MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Lixiana Product Name: Lixiana Pharmaceutical Form: Film-coated tablet INN or Proposed INN: EDOXABAN CAS Number: 480449-70-5 Other descriptive name: EDOXABAN Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion 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 and troponin = ULN and/or D-dimer =0.5 mg/L • Legally effective declaration of informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 59 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 113

Exclusion criteria

Exclusion criteria: • Age below 18 • Life expectancy less than 3 months before COVID-19 • Resuscitation > 30 minutes • Contraindications against the use of each of the standard LMWH/ Fondaparinux according to the • respective SmPC • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: (i) 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 pa-tients with COVID-19 (ii) To assess safety and tolerability of Edoxaban and high dose LMWH on top of SOC in patients with COVID-19;Secondary Objective: Furthermore, secondary objectives intend to evaluate the effect of both treatment regimes with respect to all-cause mortality, mortality related to venous and arterial thromboembolism, rate of arterial/ venous throm-boembolism, rate and length of mechanical ventilation, length of inital stay at ICU, rehospitalization, rate and length of renal replacement ther-apy, cardiac arrest and CPR.;Primary end point(s): Efficacy: Combined endpoint: all-cause mortality and/ or venous thromboembolism and/ or arterial thromboembolism within 42 days Safety endpoints: •Rate of SAEs/ AEs/ SUSARs in both arms within 42 days •Major and clinically relevant non-major bleeding according ISTH •Interruption of therapy due to intolerability to Edoxaban •New treatment-emergent adverse events (and changes in severity and frequency in these) related to Edoxaban ;Timepoint(s) of evaluation of this end point: 42 days	—

Measure

Time frame

Main Objective: (i) 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 pa-tients with COVID-19 (ii) To assess safety and tolerability of Edoxaban and high dose LMWH on top of SOC in patients with COVID-19;Secondary Objective: Furthermore, secondary objectives intend to evaluate the effect of both treatment regimes with respect to all-cause mortality, mortality related to venous and arterial thromboembolism, rate of arterial/ venous throm-boembolism, rate and length of mechanical ventilation, length of inital stay at ICU, rehospitalization, rate and length of renal replacement ther-apy, cardiac arrest and CPR.;Primary end point(s): Efficacy: Combined endpoint: all-cause mortality and/ or venous thromboembolism and/ or arterial thromboembolism within 42 days Safety endpoints: •Rate of SAEs/ AEs/ SUSARs in both arms within 42 days •Major and clinically relevant non-major bleeding according ISTH •Interruption of therapy due to intolerability to Edoxaban •New treatment-emergent adverse events (and changes in severity and frequency in these) related to Edoxaban ;Timepoint(s) of evaluation of this end point: 42 days

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Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy objectives are to compare the active treatment and placebo groups with respect to: • All-cause mortality within 42 days • Mortality related to venous thromboembolism • Mortality related to arterial thromboembolism • Rate of venous and/ or arterial thromboembolism • Rate and length of mechanical ventilation until day 42 • Length of initial stay at ICU after application of IMP up to a total of 42 days • Rehospitalisation within 42 days • Rate and length of renal replacement therapy until day 42 • Cardiac arrest/ CPR until day 42 Further assessment of safety: An expanded safety composite event including death, MI, stroke, recur-rent hospitalization, bleeding, acute kidney injury, and gastrointestinal disorders will be collected, analysed and reported. Upon medical need and/ or regulatory requirements additional visits may be scheduled. ;Timepoint(s) of evaluation of this end point: 42 days	—

Measure

Time frame

Secondary end point(s): The secondary efficacy objectives are to compare the active treatment and placebo groups with respect to: • All-cause mortality within 42 days • Mortality related to venous thromboembolism • Mortality related to arterial thromboembolism • Rate of venous and/ or arterial thromboembolism • Rate and length of mechanical ventilation until day 42 • Length of initial stay at ICU after application of IMP up to a total of 42 days • Rehospitalisation within 42 days • Rate and length of renal replacement therapy until day 42 • Cardiac arrest/ CPR until day 42 Further assessment of safety: An expanded safety composite event including death, MI, stroke, recur-rent hospitalization, bleeding, acute kidney injury, and gastrointestinal disorders will be collected, analysed and reported. Upon medical need and/ or regulatory requirements additional visits may be scheduled. ;Timepoint(s) of evaluation of this end point: 42 days

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Countries

Germany

Contacts

Public ContactElizabeth Abari

CTC North GmbH

regulatory@ctc-north.com+49040524719216

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026