Clinical trial NCT04542408: Hamburg Edoxaban for Anticoagulation in COVID-19 Study
Official title: Hamburg Edoxaban for Anticoagulation in COVID-19 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Keywords: Coagulopathy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism
timeFrame: 42 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 42 days
measure: Mortality related to venous thromboembolism
timeFrame: 42 days
measure: Mortality related to arterial thromboembolism
timeFrame: 42 days
measure: Rate of venous and/ or arterial thromboembolism
timeFrame: 42 days
measure: Rate and length of mechanical ventilation
timeFrame: 42 days
measure: Length of initial stay at ICU after application of IMP
timeFrame: 42 days
measure: Rehospitalisation
timeFrame: 42 days
measure: Rate and length of renal replacement therapy
timeFrame: 42 days
measure: Cardiac arrest/ CPR
timeFrame: 42 days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: UK Aachen
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitärsklinikum Hamburg-Eppendorf
city: Hanover
country: Germany
facility: Medizinische Hochschule Hannover
city: München
country: Germany
facility: TU München Klinikum rechts der Isar
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Stefan Kluge, MD
role: PRINCIPAL_INVESTIGATOR
References: