Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04542408
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2020-09-06
Brief Title:
Hamburg Edoxaban for Anticoagulation in COVID-19 Study
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Hamburg Edoxaban for Anticoagulation in COVID-19 Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERO-19
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 ie 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None