COVID, Sars-CoV2
Conditions
Keywords
anticoagulation, heparin, thrombosis
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.
Interventions
DRUGEnoxaparin
Two different doses of anticoagulation
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days | Risk of all-cause mortality |
| 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 |
| Sequential organ failure assessment score | 30 days | Highest score per participant |
| Clinical deterioration | 30 days | Risk of clinical deterioration |
| 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 |
| Disseminated intravascular coagulation | 30 days | Risk of DIC |
| Sepsis-induced coagulopathy | 30 days | Risk of SIC |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heparin-induced thrombocytopenia | 30 days | Risk of documented HIT |
| PaO2/FiO2 index | 30 days | Measures of PaO2/FiO2 among participants with mechanical ventilation |
| Clinically relevant non-major bleeding | 30 days | Risk of ISTH-defined CRNMB |
| Major bleeding | 30 days | Risk of ISTH-defined major bleeding |
Countries
Switzerland
Outcome results
None listed