Hamburg Edoxaban foR anticoagulation in COvid-19 study

Phase 1

• Conditions: COVID-19 [Coronavirus disease 2019]; MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002504-39-DE
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-14
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 172

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 and troponin = ULN and/or D-dimer =0.5 mg/L
•Legally effective declaration of informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 59
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 113

Exclusion Criteria

•Age below 18
•Life expectancy less than 3 months before COVID-19
•Resuscitation > 30 minutes
•Contraindications against the use of each of the standard LMWH/ Fondaparinux according to the •respective SmPC
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified