Preventing COVID-19 Complications With Low- and High-dose Anticoagulation (COVID-HEP)

University Hospitals (UH)

Status and phase: Terminated; Phase 3

Conditions: Sars-CoV2; COVID

Treatments: Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT04345848

2020-00794

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Therapeutic anticoagulation

Experimental group

Description:

Participants will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or intravenous unfractionated heparin, from admission until the end of hospital stay or clinical recovery.

Treatment:

Drug: Enoxaparin

Prophylactic anticoagulation

Active Comparator group

Description:

Participants will be treated with prophylactic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or unfractionated heparin, from admission until the end of hospital stay or clinical recovery. If hospitalized in the intensive care unit, they will receive an augmented thromboprophylaxis regimen as standard of care.

Treatment:

Drug: Enoxaparin