To study if giving a small dose of a blood-thinning drug (enoxaparin) at an early stage of the COVID-19 infection can prevent worsening of the illness and avoid the need for hospital admissio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1370

Inclusion Criteria

•Signed consent form
• Confirmed COVID-19 (i.e. symptoms + positive PCR test for SARS-CoV-2)
• Male or female, age = 30 years
• Negative pregnancy test for female patients of reproductive potential
• At least one of the following additional risk factors:
o Age = 70 years
o Body mass index > 25 kg/m2
o Chronic obstructive pulmonary disease (COPD)*(chronic obstructive lung disease, chronic bronchitis, chronic obstructive asthma, interstitial lung disease)
o Diabetes*
o Cardiovascular disease*(coronary artery disease, PAD, heart valve disease, treated arrhythmia, heart failure, hypertension, congenital heart disease, prior stroke or TIA, carotid artery disease)
oPrevious venous thromboembolism (deep vein thrombosis or pulmonary embolism)
oLiver disease* (alcoholic cirrhosis, non-alcoholic cirrhosis, chronic non-alcoholic liver disease, chronic hepatitis C, chronic hepatitis B, cryptogenic cirrhosis).
oImmunocompromised state (due to blood or bone marrow transplant, immunodeficiencies, HIV infection, systemic corticosteroid use or other medication that weakens the immune system [e.g. active cancer treatment])
oAnaemia of chronic disease or sickle cell disease

*Defined as any disease requiring medical intervention or treatment.
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

• Contraindications to unfractionated heparin or LMWH (History of immune mediated heparin-induced thrombocytopenia, active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; hypersensitivity, etc).
• Received any COVID-19 vaccination
• Recent (<48 hours) or planned spinal or epidural anesthesia or puncture, PCI or thrombolytic therapy within the preceding 24 hours
• Increased risk for bleeding complications
• Pregnant women
• Severe renal impairment (GFR < 30 mL/min)
• Receiving any antiplatelet therapy (with the exception of low dose (= 100mg) aspirin) or clopidogrel (=75mg) monotherapy or anticoagulant therapy (e.g. VKA, DOAC)
• Patients participating in an interventional study that is outside the purview of TRI sponsored studies.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the superiority of prophylactic enoxaparin compared to the current standard of care (no enoxaparin) in reducing hospital admission and/or death within 21 days of randomisation in symptomatic individuals with COVID-19 in a community setting;Secondary Objective: • Evaluate the bleeding risk of prophylactic enoxaparin in symptomatic individuals with COVID-19 in a community setting compared to the current standard of care (no enoxaparin), within 21 days of randomisation.<br>• Assess whether prophylactic enoxaparin reduces the number of individuals admitted to hospital requiring supplemental oxygen within 21 days of randomisation.<br>• Assess whether prophylactic enoxaparin reduces the incidence of venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) or ischemic stroke within 21 days of randomisation;Primary end point(s): The composite of hospitalization or all-cause death within 21 days after randomization.;Timepoint(s) of evaluation of this end point: 21 Days

Secondary Outcome Measures

Name	Time	Method

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