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

Phase 1

• Conditions: Confirmed diagnosis of SARS-CoV-2 with symptomatic COVID-19 infection; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-003125-39-BE
• Lead Sponsor: Thrombosis Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-22
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1370

Inclusion Criteria

•Signed Informed consent
•Confirmed COVID-19 (i.e. symptoms + positive test for SARS-CoV-2)
•Male or female, age = 55 years
•At least two of the following additional risk factors:
oAge = 70 years
oBody mass index > 25 kg/m2
oChronic obstructive pulmonary disease (COPD)*
oDiabetes*
oCardiovascular disease*
oCorticosteroid use
*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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Contraindications to unfractionated heparin or LMWH
•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 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<br>;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