Enoxaparin for thromboprophylaxis in hospitalized COVID-19 patients: comparison of 40 mg o.d. versus 40 mg b.i.d. A randomized Clinical Trial

Phase 1

• Conditions: SARS-CoV-2 Infection; MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001708-41-IT
• Lead Sponsor: AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2712

Inclusion Criteria

All-comers patients aged >=18 years and admitted to hospital with laboratory-confirmed SARS-CoV-2 infection.
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 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

• Patients admitted directly to an intensive care unit;
• Estimated creatinine clearance <15 ml/min/1.73m2;
• Patients needing anticoagulant for prior indication;
• Patients treated with heparin at any increased dose compared to prophylactic regimen before enrolment;
• Patients at high bleeding risk or experiencing clinically significant bleeding;
• Patients involved in competitive clinical trials exploring antithrombotic treatments;
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial

Study & Design

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