Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients

Completed · Phase 3

Conditions studied: Sars-CoV2, COVID

In brief

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

Key facts

Study ID

NCT04401293

Run by

Northwell Health

People needed

257

Starts

2020-04-26

Expected to finish

2021-05-14

Last updated by the study team

2021-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Either a D- Dimer > 4.0 X ULN, OR
• Sepsis-induced coagulopathy (SIC) score of ≥4

You may not qualify if…

• 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,
• Hepatic failure with a baseline INR > 1.5,
• CrCl < 15ml/min,
• a platelet count < 25,000,
• a history of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies,
• contraindications to enoxaparin including a hypersensitivity to enoxaparin sodium, hypersensitivity to heparin or pork products, hypersensitivity to benzyl alcohol,
• pregnant female,
• inability to give or designate to give informed consent,
• participation in another blinded trial of investigational drug therapy for COVID-19

Where it is running

• Beth Israel Newark — Newark, New Jersey, United States
• Southside Hospital — Bay Shore, New York, United States
• Huntington Hospital — Huntington, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Long Island Jewish Medical Center — Queens, New York, United States
• Staten Island University Hospital — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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