Status:
TERMINATED
Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients
Lead Sponsor:
Thrombosis Research Institute
Collaborating Sponsors:
Sanofi
Conditions:
COVID-19
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
Evidence has shown that COVID-19 infections can lead to an increased risk of blood clots. These blood clots can lead to individuals being admitted to hospital, or, unfortunately in severe cases, death...
Detailed Description
This is an open label randomized controlled trial of symptomatic individuals with confirmed COVID-19 in a community setting. Justification: There is currently no standard of care treatment for Covid-...
Eligibility Criteria
Inclusion
- 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:
- Age ≥ 70 years Body mass index \> 25 kg/m2 Chronic obstructive pulmonary disease (COPD)\* Diabetes\* Cardiovascular disease\* Corticosteroid use
- \*Defined as any disease requiring medical intervention or treatment.
Exclusion
- 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.
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT04492254
Start Date
October 27 2020
End Date
November 29 2021
Last Update
May 2 2022
Active Locations (3)
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1
Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital
Melbourne, Australia
2
Dr Frank Cools, National Co-ordinating Investigator, AZ Klina
Brasschaat, Belgium
3
Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand
Johannesburg, South Africa