A Phase 3 interventional study of Enoxaparin in COVID and Sars-CoV2, sponsored by University Hospital, Geneva. Terminated at 4 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-14.
Sponsored by University Hospital, Geneva · Phase 3, Interventional, and Treatment
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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 160 is above the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: adult patient with COVID-19 infections, admitted to:
Exclusion Criteria:
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.
Drug: 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.
Drug: Enoxaparin
Two different doses of anticoagulation
Also known as: Unfractionated heparin
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
Major bleeding
Risk of ISTH-defined major bleeding
Time frame: 30 days
Clinically relevant non-major bleeding
Risk of ISTH-defined CRNMB
Time frame: 30 days
Heparin-induced thrombocytopenia
Risk of documented HIT
Time frame: 30 days
PaO2/FiO2 index
Measures of PaO2/FiO2 among participants with mechanical ventilation
Time frame: 30 days
Plan to share: Undecided
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva