Abstract

Background: The efficacy and safety of prophylactic full-dose anticoagulation and antiplatelet therapy in critically-ill COVID-19 patients remains uncertain.

Methods: COVID-PACT was a multicenter, 2x2 factorial, open-label, randomized-controlled trial with blinded endpoint adjudication in ICU-level patients with COVID-19. Patients were randomized to a strategy of full-dose anticoagulation or standard-dose prophylactic anticoagulation. Absent an indication for antiplatelet therapy, patients were additionally randomized to either clopidogrel or no antiplatelet therapy. The primary efficacy outcome was the hierarchical composite of death due to venous or arterial thrombosis, pulmonary embolism, clinically-evident deep venous thrombosis (DVT), type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically-silent DVT, through hospital discharge or 28 days. The primary efficacy analyses included an unmatched win-ratio and time-to-first event analysis while patients were on-treatment. The primary safety outcome was fatal or life-threatening bleeding. The secondary safety outcome was GUSTO moderate/severe bleeding. Recruitment was stopped early in 03/2022 (∼50% planned recruitment) due to waning ICU-level COVID-19 rates.

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