Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19

Study Overview
=================
Brief Summary
-----------------
Coronavirus COVID-19 is an emerging virus also called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Eighty percent of patients are poor or asymptomatic. However, there are major respiratory complications for some patients, requiring intensive care hospitalization and possibly leading to death in 5% of cases. One of the hypotheses put forward is that much of the pathophysiology is due to endothelial dysfunction associated with disseminated intravascular coagulation. The covid-19 pathology could induce coagulation impairment as observed during sepsis. An increase in D-dimer levels during covid-19 disease is itself associated with excess mortality. While D-dimers are highly sensitive, they are not specific for clotting activity. They may be increased in many other circumstances, particularly in inflammation. On the other hand, the infection stimulates the release of extracellular vesicles. These vesicles, of multiple cellular origin, are an actor of vascular homeostasis, and participate in the state of hyperactivation of coagulation. They have a major role in the prothrombotic state and the development of coagulopathy associated with sepsis. The aim of our monocentric prospective study would be to study early and more specific markers of hypercoagulability and markers of routine endothelial dysfunction, as soon as the patient is hospitalized, in order to predict the risk of hospitalization in intensive care.

Official Title
-----------------
Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Procedure: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient admitted to Rouen University Hospital for documented SARS-Cov-2 infection (PCR Test or CT scan) Patient who accept to participate to research after reading the information note Patient affiliated with Social Security Exclusion Criteria: Patient under protective guardianship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with COVID-19 infection<br>Patient with COVID-19 infection hospitalized in a COVID unit | Procedure: blood sampling<br>* blood sampling in hospitalized patient for COVID-19 infection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical worsening (yes/no) of the patient during hospitalization |  | in the 15 days from admission | 
| D-DIMERS plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 
| Fibrin monomers plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 
| Antithrombin plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 
| Prothrombin Fragment 1 plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 
| Prothrombin Fragment 2 plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 
| Thrombin generation test plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 
| Microvesicles of platelet plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 
| Cross-linked platelets plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 
| Willebrand Factor plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 
| Factor VIII plasma levels in blood | Biological analysis using initial blood sampling | 1 hour after admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemostasis