Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19
Condition: COVID-19; Venous Thromboses; Arterial Thrombosis
MeSH terms: COVID-19; Thrombosis; Thromboembolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to assess the effectiveness of intermediate versus prophylactic
      doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the
      intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's
      usual standard of care but determining the dose of anticoagulation is based on physician
      preference. The investigators are conducting this study (a randomized trial with adaptive
      design employing cluster randomization) with the support of all of the ICUs to collect data
      in order to determine what should be the standard of care in terms of anticoagulation in
      these critically ill patients. The patients care will not be altered other than the choice of
      anticoagulation (both approved and used throughout the hospital as standard of care) based on
      the ICU bed they are assigned. Patient data will be collected until discharge.
    

Detailed description: 
      Hemostatic, biomarker, and inflammatory changes are common in severe manifestations of
      coronavirus disease 2019 (COVID-19).Such factors, as well as the bedridden status and
      critical illness may constitute a prothrombotic milieu, predisposing to venous and arterial
      thrombosis. However, the optimal antithrombotic regimen for patients with COVID-19,
      especially those with severe disease, remains uncertain and is currently an area of active
      clinical interest. Prophylactic-dose anticoagulation is generally recommended for acutely ill
      hospitalized patients. However, given the hemostatic abnormalities of severe COVID-19
      illness, it is unknown whether more intensive anticoagulation is preferred to reduce the risk
      of thrombotic events, potentially mitigating microvascular and macrovascular thrombi and even
      disseminated intravascular coagulation (DIC). Further, the risks of therapeutic dose
      anticoagulation must be weighed against the bleeding risks inherent to this approach. To
      address this critical gap in knowledge in an area of clinical equipoise, the investigators
      plan to conduct a cluster-randomized trial in patients admitted to intensive care units
      (ICUs) in a large volume academic medical center to select the best anticoagulation
      intervention.
    

Intervention name(s): Enoxaparin Prophylactic Dose; Heparin Infusion; Heparin SC; Enoxaparin/Lovenox Intermediate Dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
BMI < 40 kg/m2: Enoxaparin 40 mg SC daily
BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
BMI > 50 kg/m2: Enoxaparin 60 mg SC q12h; Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.; Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.; If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
Other intervention name(s): Lovenox; Heparin; Heparin; Lovenox
Intervention MeSH terms: Heparin; Calcium heparin; Enoxaparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19; coronavirus; anticoagulation