Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients (NCT04401293) | Clinical Trial Compass
CompletedPhase 3
Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
United States257 participantsStarted 2020-04-26
Plain-language summary
The aim of this study is to test the hypothesis that prophylaxis of severe COVID-19 patients with treatment dose LMWH leads to better thromboembolic-free outcomes and associated complications during hospitalization than prophylaxis with institutional standard of care with prophylactic to intermediate-doses of UFH or LMWH
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
✓. Understands and agrees to comply with planned study procedures.
✓. Male or non-pregnant female adult ≥18 years of age at time of enrollment.
✓. Subject consents to randomization within 72 hours of hospital admission or transfer from another facility within 72 hours of index presentation.
✓. Subjects with a positive COVID-19 diagnosis by nasal swab or serologic testing.
✓. Hospitalized with a requirement for supplemental oxygen.
✓. Have:
Exclusion criteria
✕. Indications for therapeutic anticoagulation
✕. Absolute contraindication to anticoagulation including:
✕. active bleeding,
✕. recent (within 1 month) history of bleed,
✕. dual (but not single) antiplatelet therapy,
✕. active gastrointestinal and intracranial cancer,
✕. a history of bronchiectasis or pulmonary cavitation,
What they're measuring
1
Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days.