RWF: A Multicenter, Randomized-Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically-Ill COVID-19 Patients

This is a multicenter, open-label, 2x2 factorial, randomized-controlled trial in critically-ill patients with novel coronavirus disease 2019 (COVID-19) evaluating the efficacy and safety of full-dose vs. standard prophylactic dose anticoagulation and of antiplatelet vs. no antiplatelet therapy for prevention of venous and arterial thrombotic events.

Inclusion Criteria:
• Acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)
• Currently admitted to an intensive care unit (ICU)

Exclusion Criteria:
• Ongoing (>48 hours) or planned full-dose (therapeutic) anticoagulation for any indication
• Ongoing or planned treatment with dual antiplatelet therapy
• Contraindication to antithrombotic therapy or high risk of bleeding due to conditions including, but not limited to, any of the following:
o History of intracranial hemorrhage, known CNS tumor or CNS vascular abnormality
o Active or recent major bleeding within the past 30 days with untreated source
o Platelet count <70,000 or known functional platelet disorder
o Fibrinogen <200 mg/dL
o International normalized ratio (INR) >1.9
• History of heparin-induced thrombocytopenia
• Ischemic stroke within the past 2 weeks
Patients who meet the following criterion are excluded from the second randomization (antiplatelet therapy vs. no antiplatelet therapy):
• Ongoing or planned antiplatelet therapy, including aspirin monotherapy
Phase IV
Jason Wells, M.D.
The TIMI Study Group
Kim Sutcliffe
  • Providence Portland Medical Center