Hamburg Edoxaban for Anticoagulation in COVID-19 Study

Covid19 Clinical Trial

— HERO-19  

Official title:

Hamburg Edoxaban for Anticoagulation in COVID-19 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542408
• Other study ID #: HERO-19
• Status: Completed
• Phase: Phase 3
• Start date: November 12, 2020
• Est. completion date: January 15, 2023

Study information

• Verified date: May 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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