Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)

InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial)

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.

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.