Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
Condition: Sars-CoV2; COVID
MeSH terms: COVID-19
Intervention: Enoxaparin; Prophylactic/Intermediate Dose Enoxaparin
Intervention description: Full Dose LMWH anticoagulation therapy; Prophylactic/Intermediate Dose LMWH or UFH therapy
Intervention MeSH terms: Heparin; Enoxaparin; Calcium heparin; Dalteparin; Enoxaparin sodium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Due to the pragmatic nature of this study "open-label multi-center randomized active control trial" with pseudo-blinding mechanisms at the time of randomization the study subject and corresponding Site PIs will be blinded (unaware of specific treatment arm the patient is assigned to i.e. Arm 0 or Arm 1). The study pharmacists as well as data extractors and designated randomization personnel (i.e. research coordinators and/or research nurses performing the randomization process) will be un-blinded (aware of specific treatment arm the patient is assigned to i.e. Arm 0 or Arm 1). At the time of subject randomization study subjects will be stratified to either ICU level of care vs. Non-ICU level of care.
Enrollment: 257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Anticoagulation; Heparin; Coronavirus; Thrombosis

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
    

Eligibility 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