Hamburg Edoxaban for Anticoagulation in COVID-19 Study

NCT04542408 | Completed Phase 3 DMC

• 1 other identifier: HERO-19
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 10

Brief 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. placebo within this trial) in reduction of morbidity and mortality endpoints in patients with COVID-19.

Conditions

Covid19

Keywords

Coagulopathy

Outcome Measures

Primary Outcomes (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.

  42 days

Secondary Outcomes (9)

• All-cause mortality

  42 days

• Mortality related to venous thromboembolism

  42 days

• Mortality related to arterial thromboembolism

  42 days

• Rate of venous and/ or arterial thromboembolism

  42 days

• Rate and length of mechanical ventilation

  42 days

Study Arms (2)

Intensive anticoagulation strategy

EXPERIMENTAL

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

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

Moderate anticoagulation strategy

OTHER

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

Drug: Low dose Low molecular weight heparin or Placebo

Interventions

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

Intensive anticoagulation strategy

Low dose Low molecular weight heparin or Placebo DRUG

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

Moderate anticoagulation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (10)

UK Aachen

Aachen, Germany

Location

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Asklepios Klinik Altona

Hamburg, Germany

Location

Asklepios Klinik Barmbek

Hamburg, Germany

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Universitärsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

TU München Klinikum rechts der Isar

München, Germany

Location

Related Publications (1)

• 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.

  PMID: 37591523 DERIVED

MeSH Terms

Conditions

COVID-19; Hemostatic Disorders

Interventions

Anticoagulants; edoxaban; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Stefan Kluge, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 9, 2020
• Study Start: November 12, 2020
• Primary Completion: September 6, 2022
• Study Completion: January 15, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)