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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Two different doses of anticoagulation
Geneva University Hospitals
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland
Ospedale Regionale di Locarno
Locarno, Switzerland
Hôpital du Valais
Sion, Switzerland
Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
Time frame: 30 days
Arterial thrombosis
Risk of ischemic stroke, myocardial infarction and/or limb ischemia
Time frame: 30 days
Venous thromboembolism
Risk of symptomatic venous thromboembolism or asymptomatic proximal leg deep vein thrombosis
Time frame: 30 days
Disseminated intravascular coagulation
Risk of DIC
Time frame: 30 days
All-cause mortality
Risk of all-cause mortality
Time frame: 30 days
Sepsis-induced coagulopathy
Risk of SIC
Time frame: 30 days
Acute respiratory distress syndrome
Risk of ARDS
Time frame: 30 days
Durations of hospital stay, ICU stay, ventilation
Number of days with these care processes
Time frame: 30 days
Sequential organ failure assessment score
Highest score per participant
Time frame: 30 days
Clinical deterioration
Risk of clinical deterioration
Time frame: 30 days
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