6/28/23, 12:20 AM COVID-PACT (anticoagulant therapy) Pathway Feedback Search Clinical Topics Home Studies COVID PACT (anticoagulant therapy) COVID PACT (anticoagulant therapy) Disease COVID 19 infection Trial question Is full-dose anticoagulation prophylaxis superior to standard-dose prophylactic anticoagulation in critically ill patients with COVID-19? Study design Multi-center Open label RCT Population Characteristics of study participants 41.0% female N = 382 59.0% male 382 patients (156 female, 226 male) Inclusion criteria: adult patients with COVID-19 infection requiring ICU-level of care Key exclusion criteria: use of full-dose anticoagulation; contraindication to antithrombotic therapy; high risk of bleeding; heparin-induced thrombocytopenia; or ischemic stroke within the past 2 weeks Interventions N=191 full-dose anticoagulation strategy (intravenous UFH or subcutaneous LMWH) N=191 standard-dose prophylactic anticoagulation strategy (LMWH) Primary outcome Rate of death due to venous or arterial thrombosis, pulmonary embolism, clinically evident deep venous thrombosis, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute https://web.pathway.md/studies/recsEiyJLcUmCKMEm 1/2 6/28/23, 12:20 AM COVID-PACT (anticoagulant therapy) Pathway limb ischemia, or clinically silent deep venous thrombosis, through hospital discharge or 28 days, time-to-first event analysis 15.2 % 15.2 11.4 % 9.9 Significant decrease 7.6 % NNT = 19 3.8 % 0.0 % Full-dose anticoagulation strategy Standard-dose prophylactic anticoagulation strategy Significant decrease in the rate of death due to venous or arterial thrombosis, PE, clinically evident DVT, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically silent DVT, through hospital discharge or 28 days, time-to-first event analysis (9.9% vs. 15.2%; HR 0.56, 95% CI 0.32 to 0.99) Secondary outcomes No significant difference in death attributable to venous or arterial thrombosis, PE, clinically evident DVT, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia (7.3% vs. 12%; HR 0.55, 95% CI 0.28 to 1.08) No significant difference in death from all causes (18.8% vs. 16.8%; HR 1.1, 95% CI 0.68 to 1.79) Safety outcomes No significant difference in fatal and life-threatening bleeding. Significant difference in GUSTO moderate and severe bleeding (7.9% vs. 0.5%). Conclusion In adult patients with COVID-19 infection requiring ICU-level of care, full-dose anticoagulation strategy was superior to standard-dose prophylactic anticoagulation strategy with respect to the rate of death due to venous or arterial thrombosis, PE, clinically evident DVT, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically silent DVT, through hospital discharge or 28 days, time-to-first event analysis. Reference Erin A Bohula, David D Berg, Mathew S Lopes et al. Anticoagulation and Antiplatelet Therapy for Prevention of Venous and Arterial Thrombotic Events in Critically Ill Patients with COVID-19: COVID-PACT. Circulation. 2022 Nov;146(18):1344-1356. Open reference URL https://web.pathway.md/studies/recsEiyJLcUmCKMEm 2/2