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

• Status: Completed
• Trial end date: 2021-05-14
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: Calcium heparin; Dalteparin; Enoxaparin; Enoxaparin sodium; Heparin

Criteria

Inclusion Criteria:

1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.

2. Understands and agrees to comply with planned study procedures.

3. Male or non-pregnant female adult ≥18 years of age at time of enrollment.

4. Subject consents to randomization within 72 hours of hospital admission or transfer from another facility within 72 hours of index presentation.

5. Subjects with a positive COVID-19 diagnosis by nasal swab or serologic testing.

6. Hospitalized with a requirement for supplemental oxygen.

7. Have:

• Either a D- Dimer > 4.0 X ULN, OR

• Sepsis-induced coagulopathy (SIC) score of ≥4

Exclusion Criteria:

1. Indications for therapeutic anticoagulation

2. Absolute contraindication to anticoagulation including:

1. active bleeding,

2. recent (within 1 month) history of bleed,

3. dual (but not single) antiplatelet therapy,

4. active gastrointestinal and intracranial cancer,

5. a history of bronchiectasis or pulmonary cavitation,

6. Hepatic failure with a baseline INR > 1.5,

7. CrCl < 15ml/min,

8. a platelet count < 25,000,

9. a history of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies,

10. contraindications to enoxaparin including a hypersensitivity to enoxaparin sodium, hypersensitivity to heparin or pork products, hypersensitivity to benzyl alcohol,

11. pregnant female,

12. inability to give or designate to give informed consent,

13. participation in another blinded trial of investigational drug therapy for COVID-19