Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19

Study Overview
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Brief Summary
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The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.

Detailed Description
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Between December 2019 and January 2020, a new type of coronavirus, named as coronavirus disease 2019 - COVID-19 by the World Health Organization, has widely spread throughout the world, becoming a global health threat. The new COVID-19 is similar to other two types of coronavirus that in the past two decades have emerged as cause of severe human disease: Severe Acute Respiratory Syndrome CoV (SARS-CoV) and Middle East Respiratory Syndrome CoV (MERS-CoV). Severe respiratory disease or respiratory failure are the principal symptoms of critical patients, needing a management in ICU with mechanical ventilation.18 Data coming from laboratory results show a leucopenia mainly represented by a lymphopenia, that is a cardinal feature of COVID-19. Moreover, the concentration of several serum pro-thrombotic cytokines, such as interleukins (mainly IL-6, increased in 52% of patients), TNF-α, D-Dimer are reported to be significantly higher in COVID-19 patients, and significantly higher in ICU-patients than in non-ICU patients, suggesting an increased hypercoagulable state that, joined to the other main risk factors (immobilization, ICU admission, mechanical ventilation, infective disease), place these patients to a potential greater risk of developing VTE complications.

Official Title
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Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19)

Conditions
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COVID-19 Disease, Thromboembolism, Venous

Intervention / Treatment
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* Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged >= 18 years needing admission to a medical hospital division or to an ICU with a confirmed infection for COVID-19 Exclusion Criteria: aged < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical<br>subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease | Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux<br>* thromboprophylaxis with low-molecular-weight heparin or fondaparinux<br>* Other names: thromboprophylaxis;|
| Intensive<br>subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease | Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux<br>* thromboprophylaxis with low-molecular-weight heparin or fondaparinux<br>* Other names: thromboprophylaxis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism | the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism | the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 pandemic, Thromboembolism, Venous, Deep Venous Thrombosis, Pulmonary Thrombosis