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

Phase 3

Terminated

• Conditions: Sars-CoV2; COVID
• Interventions: Drug: Enoxaparin

• Registration Number: NCT04345848
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-15
• Study Start: 2020-04-28
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic anticoagulation	Enoxaparin	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.
Prophylactic anticoagulation	Enoxaparin	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.

Primary Outcome Measures

Name	Time	Method
Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality	30 days	Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality

Secondary Outcome Measures

Name	Time	Method
Sepsis-induced coagulopathy	30 days	Risk of SIC
Sequential organ failure assessment score	30 days	Highest score per participant
Disseminated intravascular coagulation	30 days	Risk of DIC
All-cause mortality	30 days	Risk of all-cause mortality
Arterial thrombosis	30 days	Risk of ischemic stroke, myocardial infarction and/or limb ischemia
Venous thromboembolism	30 days	Risk of symptomatic venous thromboembolism or asymptomatic proximal leg deep vein thrombosis
Acute respiratory distress syndrome	30 days	Risk of ARDS
Durations of hospital stay, ICU stay, ventilation	30 days	Number of days with these care processes
Clinical deterioration	30 days	Risk of clinical deterioration

Trial Locations

Locations (4)

Centre Hospitalier Universitaire Vaudois (CHUV); 🇨🇭 Lausanne, Switzerland

Ospedale Regionale di Locarno; 🇨🇭 Locarno, Switzerland

Hôpital du Valais; 🇨🇭 Sion, Switzerland

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland