Hamburg Edoxaban for Anticoagulation in COVID-19 Study (HERO-19)
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ClinicalTrials.gov Identifier: NCT04542408 |
Recruitment Status :
Recruiting
First Posted : September 9, 2020
Last Update Posted : November 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Drug: Anticoagulation Agents (Edoxaban and/or high dose LMWH) Drug: Low dose Low molecular weight heparin or Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 172 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Hamburg Edoxaban for Anticoagulation in COVID-19 Study |
Actual Study Start Date : | November 12, 2020 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | September 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Intensive anticoagulation strategy
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
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Drug: 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 |
Moderate anticoagulation strategy
In-hospital (ICU & normal ward): LMWH, prophylactic dose as part of SOC After discharge and in ambulatory patients: Administration of oral placebo according to the dosing rules for Edoxaban
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Drug: 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 |
- Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism [ Time Frame: 42 days ]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.
- All-cause mortality [ Time Frame: 42 days ]All-cause mortality during follow-up (42 days)
- Mortality related to venous thromboembolism [ Time Frame: 42 days ]Mortality related to venous thromboembolism during follow-up (42 days)
- Mortality related to arterial thromboembolism [ Time Frame: 42 days ]Mortality related to arterial thromboembolism during follow-up (42 days)
- Rate of venous and/ or arterial thromboembolism [ Time Frame: 42 days ]Rate of venous and/ or arterial thromboembolism during follow-up (42 days) Thromboembolisms will be detected by duplex ultrasonography of arms and legs
- Rate and length of mechanical ventilation [ Time Frame: 42 days ]Rate and length of mechanical Ventilation during follow-up (42 days)
- Length of initial stay at ICU after application of IMP [ Time Frame: 42 days ]Length of initial stay at ICU after application of IMP during follow-up (42 days)
- Rehospitalisation [ Time Frame: 42 days ]Rehospitalisation during follow-up (42 days)
- Rate and length of renal replacement therapy [ Time Frame: 42 days ]Rate and length of renal replacement therapy during follow-up (42 days)
- Cardiac arrest/ CPR [ Time Frame: 42 days ]Cardiac arrest/ CPR during follow-up (42 days)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542408
Contact: Stefan Kluge, MD | +49 40 7410 ext 57010 | s.kluge@uke.de | |
Contact: Mahir Karakas, MD | +49 152 22817493 | m.karakas@uke.de |
Germany | |
Universitätsklinikum Düsseldorf | Not yet recruiting |
Düsseldorf, Germany | |
Contact: Bode, MD | |
Universitätsklinikum Freiburg | Not yet recruiting |
Freiburg, Germany | |
Contact: Hans-Jörg Busch | |
Marienkrankenhaus | Not yet recruiting |
Hamburg, Germany | |
Contact: Schäfer, MD | |
Universitärsklinikum Hamburg-Eppendorf | Recruiting |
Hamburg, Germany | |
Contact: Stefan Kluge, MD s.kluge@uke.de | |
Medizinische Hochschule Hannover | Not yet recruiting |
Hanover, Germany | |
Contact: Tobias Welte, MD | |
Krankenhaus Köln-Merheim | Not yet recruiting |
Köln, Germany | |
Contact: Christian Karagiannidis, MD | |
TU München Klinikum rechts der Isar | Not yet recruiting |
München, Germany | |
Contact: Tobias Lahmer | |
Universitätsklinikum Münster | Not yet recruiting |
Münster, Germany | |
Contact: Hartmut Schmidt, MD |
Principal Investigator: | Stefan Kluge, MD | Universitätsklinikum Hamburg-Eppendorf |
Responsible Party: | Universitätsklinikum Hamburg-Eppendorf |
ClinicalTrials.gov Identifier: | NCT04542408 |
Other Study ID Numbers: |
HERO-19 |
First Posted: | September 9, 2020 Key Record Dates |
Last Update Posted: | November 18, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coagulopathy |
Heparin Heparin, Low-Molecular-Weight Tinzaparin Dalteparin Edoxaban Anticoagulants Fibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |