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Covid19Phase 3HERO-19NCT04542408

Hamburg Edoxaban for Anticoagulation in COVID-19 Study

A Phase 3 study testing Anticoagulation Agents (Edoxaban and/or high dose LMWH) in people with Covid19, run by Universitätsklinikum Hamburg-Eppendorf at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Anticoagulation Agents (Edoxaban and/or high dose LMWH)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
10 sitesGermany
Study dates
12 Nov 2020to 15 Jan 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • UK Aachen

    Aachen

  • Universitätsklinikum Augsburg

    Augsburg

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Asklepios Klinik Altona

    Hamburg

  • Asklepios Klinik Barmbek

    Hamburg

  • Asklepios Klinik St. Georg

    Hamburg

  • Universitärsklinikum Hamburg-Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • TU München Klinikum rechts der Isar

    München

Other trials in Germany

About this study

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.

Read the detailed description

Coagulopathy in the context of COVID-19 is a major threat to affected patients due to deep vein thromboses and pulmonary embolisms. Actual data show an unexpectedly high incidence of partially fatal complications without any prior clinical evidence in some cases. Therefore, this prospective, randomized, assessor-blinded, multicenter, placebo-controlled, interventional trial will investigate whether therapeutic anticoagulation on top of SOC compared to prophylactic anticoagulation as part of SOC- can improve objective patient-relative endpoints, relevant for prognosis in patients with COVID-19. 172 eligible patients will be randomized 1:1 to experimental or control group. Patients enrolled to experimental group will receive therapeutic anticoagulation using LMWH body weight-adapted during course of hospital stay and oral anticoagulation using Edoxaban according to SmPC (60mg once a day) after being discharged from hospital / outpatient course. Patients enrolled to control group will receive prophylactic anticoagulation using LMWH as part of SOC whilst inpatient course, and placebo after discharge / outpatient course. Patients will be informed of their allocation to the placebo group, as it has been shown that the effect of placebo is still detectable.

Conditions
Covid19
Being tested
Anticoagulation Agents (Edoxaban and/or high dose LMWH), Low dose Low molecular weight heparin or Placebo
Keywords
Coagulopathy
Medical subject headings
COVID-19, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anticoagulation Agents (Edoxaban and/or high dose LMWH)Drug

    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

  • Low dose Low molecular weight heparin or PlaceboDrug

    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

Study groups in NCT04542408
Study groupRoleWhat they receive
Intensive anticoagulation strategyExperimentalIn-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
Receives: Drug: Anticoagulation Agents (Edoxaban and/or high dose LMWH)
Moderate anticoagulation strategyOtherIn-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
Receives: Drug: Low dose Low molecular weight heparin or Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 42 days

Secondary outcomes (9)

  1. All-cause mortality

    All-cause mortality during follow-up (42 days)

    Measured: 42 days

  2. Mortality related to venous thromboembolism

    Mortality related to venous thromboembolism during follow-up (42 days)

    Measured: 42 days

  3. Mortality related to arterial thromboembolism

    Mortality related to arterial thromboembolism during follow-up (42 days)

    Measured: 42 days

  4. 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

    Measured: 42 days

  5. Rate and length of mechanical ventilation

    Rate and length of mechanical Ventilation during follow-up (42 days)

    Measured: 42 days

  6. 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)

    Measured: 42 days

  7. Rehospitalisation

    Rehospitalisation during follow-up (42 days)

    Measured: 42 days

  8. Rate and length of renal replacement therapy

    Rate and length of renal replacement therapy during follow-up (42 days)

    Measured: 42 days

  9. Cardiac arrest/ CPR

    Cardiac arrest/ CPR during follow-up (42 days)

    Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start12 Nov 2020
  3. Primary completion6 Sep 2022
  4. Study completion15 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542408
Sponsor's protocol ID
HERO-19
Acronym
HERO-19
Status last verified
May 2023
First submitted
6 Sep 2020
Last updated
23 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karakas M, Nicolay SS, Wichmann D, Schmiedel S, Addo MM, Nosko A, Lund N, Shrivastava A, Pink I, Duerschmied D, Gauchel N, Schnoy E, Pape UF, Bein B, Brasch P, Arnold D, Maevers K, Rasch S, Erber J, Lahmer T, Zeller T, Langer F, Ozga AK, Suling A, Zapf A, Jarczak D, Kluge S. Prophylactic vs Therapeutic Anticoagulation in Hospitalized Patients With COVID-19: A Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2635333. doi: 10.1001/jamanetworkopen.2026.35333.

    PubMed 42776529

  • Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.

    PubMed 37591523

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anticoagulation Agents (Edoxaban and/or high dose LMWH) in people with Covid19, run by Universitätsklinikum Hamburg-Eppendorf at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism (time frame: 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04542408, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.

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