Preventing COVID-19 Complications With Low- and High-dose Anticoagulation

• Status: Terminated
• Trial end date: 2021-06-02
• Target enrollment: 0
• Participant gender: All

Summary

The ongoing COVID-19 pandemic affects millions of humans worldwide and has led to thousands of acute medical hospitalizations. There is evidence that hospitalized cases often suffer from an important infection-related coagulopathy and from elevated risks of thrombosis. Anticoagulants may have positive effects here, to reduce the burden of thrombotic disease and the hyperactivity of coagulation, and may also hold beneficial anti-inflammatory effects against sepsis and the development of ARDS.

The investigators hypothesize that high-dose anticoagulants, compared with low-dose anticoagulants, lower the risk of venous and arterial thrombosis, disseminated intravascular coagulation (DIC) and mortality. This open-label controlled trial will randomize hospitalized adults with severe COVID-19 infection to therapeutic anticoagulation vs. thromboprophylaxis during the hospital stay.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Treatments: Calcium heparin; Enoxaparin; Heparin

Criteria

Inclusion Criteria: adult patient with COVID-19 infections, admitted to:

• an acute non-critical medical ward with admission D-dimer levels >1,000ng/mL, or

• an acute critical ward (ICU, intermediate care unit)

Exclusion Criteria:

• ongoing or planned therapeutic anticoagulation for any other indication

• contra-indication to therapeutic anticoagulation

• hypersensitivity to heparin

• personal history of heparin-induced thrombocytopenia

• suspected or confirmed bacterial endocarditis

• bleeding events or tendency due to a suspected or confirmed hemostatic bleeding disorder

• organic lesion prone to bleeding

• platelet count <50G/L, Hb level <80g/L

• ongoing or recent (<30 days) major bleeding, ischemic stroke, trauma, surgery

• use of dual antiplatelet therapy

• pregnancy

• bodyweight <40kg or >150kg.

• end of life care setting

• unwillingness to consent

• ongoing participation in a COVID-19 randomized clinical trial testing another therapeutic intervention