Covid19 Clinical Trial
— HERO-19Official title:
Hamburg Edoxaban for Anticoagulation in COVID-19 Study
Verified date | May 2023 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | January 15, 2023 |
Est. primary completion date | September 6, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | 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 |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism | All-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism during follow-up (42 days). Thromboembolisms will be detected by duplex ultrasonography of arms and legs. | 42 days | |
Secondary | All-cause mortality | All-cause mortality during follow-up (42 days) | 42 days | |
Secondary | Mortality related to venous thromboembolism | Mortality related to venous thromboembolism during follow-up (42 days) | 42 days | |
Secondary | Mortality related to arterial thromboembolism | Mortality related to arterial thromboembolism during follow-up (42 days) | 42 days | |
Secondary | Rate of venous and/ or arterial thromboembolism | Rate of venous and/ or arterial thromboembolism during follow-up (42 days) Thromboembolisms will be detected by duplex ultrasonography of arms and legs | 42 days | |
Secondary | Rate and length of mechanical ventilation | Rate and length of mechanical Ventilation during follow-up (42 days) | 42 days | |
Secondary | Length of initial stay at ICU after application of IMP | Length of initial stay at ICU after application of IMP during follow-up (42 days) | 42 days | |
Secondary | Rehospitalisation | Rehospitalisation during follow-up (42 days) | 42 days | |
Secondary | Rate and length of renal replacement therapy | Rate and length of renal replacement therapy during follow-up (42 days) | 42 days | |
Secondary | Cardiac arrest/ CPR | Cardiac arrest/ CPR during follow-up (42 days) | 42 days |
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