6/28/23, 11:02 PM HEP-COVID Pathway Feedback Search Clinical Topics Home Studies HEP COVID HEP COVID Disease COVID 19 infection Trial question Is therapeutic-dose heparin superior to standard-dose heparin in high-risk hospitalized patients with COVID-19? Study design Multi-center Double blinded RCT Population Characteristics of study participants 46.0% female N = 253 54.0% male 253 patients (117 female, 136 male) Inclusion criteria: hospitalized adult patients with COVID-19 and D-dimer levels > 4 times the ULN Key exclusion criteria: physician-determined need for full-dose anticoagulation or dual antiplatelet therapy; bleeding within the past month; active gastrointestinal or intracranial cancer; hepatic dysfunction; platelet count < 25,000/ L Interventions N=129 therapeutic-dose heparin (enoxaparin, 0.5 or 1 mg/kg subcutaneous, BID based on CrCl) N=124 standard-dose heparin (prophylactic or intermediate-dose low-molecular-weight heparin or UFH) Primary outcome https://web.pathway.md/studies/recCPXMNCvuVBJ8KB 1/2 6/28/23, 11:02 PM HEP-COVID Pathway Venous thromboembolism, arterial thromboembolism, or death from any cause at day 30 41.9 % 41.9 31.4 % 28.7 20.9 % Significant decrease 10.5 % NNT = 8 0.0 % Therapeutic-dose heparin Standard-dose heparin Significant decrease in VTE, arterial thromboembolism, or death from any cause at day 30 (28.7% vs. 41.9%; RR 0.68, 95% CI 0.49 to 0.96) Secondary outcomes Significant decrease in VTE, arterial thromboembolism, or death from any cause at day 14 (23.3% vs. 36.3%; RR 0.64, 95% CI 0.43 to 0.95) Significant decrease in VTE, arterial thromboembolism, or death in non-ICU patients (16.7% vs. 36.1%; RR 0.46, 95% CI 0.27 to 0.81) No significant difference in VTE, arterial thromboembolism, or death in ICU patients (51.1% vs. 55.3%; RR 0.92, 95% CI 0.62 to 1.39) Safety outcomes No significant difference in major bleeding. Conclusion In hospitalized adult patients with COVID-19 and D-dimer levels > 4 times the ULN, therapeutic- dose heparin was superior to standard-dose heparin with respect to VTE, arterial thromboembolism, or death from any cause at day 30. Reference Alex C Spyropoulos, Mark Goldin, Dimitrios Giannis et al. Efficacy and Safety of Therapeutic- Dose Heparin vs Standard Prophylactic or Intermediate-Dose Heparins for Thromboprophylaxis in High-risk Hospitalized Patients With COVID-19: The HEP-COVID Randomized Clinical Trial. JAMA Intern Med. 2021 Dec 1;181(12):1612-1620. Open reference URL https://web.pathway.md/studies/recCPXMNCvuVBJ8KB 2/2