Early treatment of patients with symptoms and confirmed COVID-19 with medication to prevent the disease becoming worse

Phase 1

• Conditions: ow Molecular Weight Heparin (LMWH) thromboprophylaxis in patients with COVID-19; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-003125-39-GB
• Lead Sponsor: CYTE Global

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-19
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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:
o Age = 70 years
o Body mass index > 25 kg/m2
o Chronic obstructive pulmonary disease (COPD)*
o Diabetes*
o Cardiovascular disease*
o Corticosteroid use
*Defined as any disease requiring medical intervention or treatment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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