Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
Sars-CoV2, COVID
About this trial
This is an interventional treatment trial for Sars-CoV2 focused on measuring COVID-19, Anticoagulation, Heparin, Coronavirus, Thrombosis
Eligibility Criteria
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:
- Either a D- Dimer > 4.0 X ULN, OR
- Sepsis-induced coagulopathy (SIC) score of ≥4
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,
- 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
Sites / Locations
- Beth Israel Newark
- Southside Hospital
- Huntington Hospital
- Lenox Hill Hospital
- Long Island Jewish Medical Center
- Staten Island University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Full Dose LMWH anticoagulation therapy
Prophylactic/Intermediate Dose LMWH or UFH therapy
Subjects in this study arm will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin). Enoxaparin 1mg/kg SQ BID for CrCl ≥ 30ml/min (or Enoxaparin 0.5mg/kg SQ BID for CrCl ≥ 15ml/min and < 30ml/min) during the course of their hospitalization.
Subjects in this study arm will be treated with Local institutional standard-of-care for prophylactic-dose or intermediate-dose UFH or LMWH. Regimens allowed are UFH up to 22,500 IU daily in BID or TID doses (i.e. UFH 5000 IU SQ BID/TID or 7500 IU BID/TID), enoxaparin 30mg and 40mg SQ QD or BID (the use of weight-based enoxaparin i.e. 0.5mg/kg SQ BID for this arm is acceptable but strongly discouraged), dalteparin 2500IU or 5000IU QD.