Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Enoxaparin sodium; Unfractionated heparin; Fondapariniux; Argatroban
Intervention description: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours; Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol; Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
If greater than or equal to 100 kg: 10 mg daily
If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
If less than 50 kg: 5 mg daily; Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
Intervention MeSH terms: Heparin; Calcium heparin; Enoxaparin; Enoxaparin sodium; Argatroban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Anticoagulation

Summary:

      The purpose of this study is to determine if therapeutic dose anticoagulation (experimental
      group) improves 30-day mortality in participants with COVID-19 compared to those patients
      receiving the intermediate dose prophylaxis (control group). Following screening, subjects
      will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation
      treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18 years old

          -  COVID-19 positive on (RT-PCR) nasopharyngeal swab, or suspected COVID-19 infection
             with detectable SARS-CoV-2 IgG or IgM.

          -  Intensive care unit (ICU) patient or non-ICU patient on invasive mechanical
             ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental
             oxygen of at least 4 liters per minute nasal cannula.

          -  D dimer level greater than 700 ng/mL (3 times the upper limit of normal).

        Exclusion Criteria:

          -  Objectively documented deep vein thrombosis or pulmonary embolism

          -  Patients in whom there is very high suspicion for pulmonary embolism and are on
             full-dose anticoagulation as per the treating physician

          -  Platelets <30,000 not due to disseminated intravascular coagulation (DIC), based on
             the International Society of Thrombosis and Haemostasis (ISTH) criteria and American
             Society of Hematology (ASH) Frequently Asked Questions

          -  Active bleeding that poses a contraindication to therapeutic anticoagulation in the
             opinion of the investigator.

          -  History of bleeding diathesis (e.g., hemophilia, severe von Willebrand disease, severe
             thrombocytopathy)

          -  History of intracranial hemorrhage in the last 90 days

          -  History of ischemic stroke in the past 2 weeks

          -  Major neurosurgical procedure in the past 30 days

          -  Cardiothoracic surgery in the past 30 days

          -  Intra-abdominal surgery in the past 30 days

          -  Intracranial malignancy

          -  Patients who require therapeutic anticoagulation for other reasons like atrial
             fibrillation, deep venous thrombosis, pulmonary embolism, or antiphospholipid
             syndrome.