COVID-19 : Study of INFLAmmasome and PLAtelets Functions

Study Overview
=================
Brief Summary
-----------------
COVID-19 pandemic is a severe viral sepsis characterized by the occurrence of Acute respiratory distress syndrome (ARDS) whose pathophysiology is little described

Detailed Description
-----------------
The new Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic started on December 2019 in China and spreaded in worldwide. The Coronavirus disease 2019 (COVID-19) is responsible of case of severe pneumonia whose the major risk is the development to ARDS. Concerning the pathophysiology, there appear to be hemostasis abnormalities including thrombocytopenia and coagulopathy. In recent studies, this thrombocytopenia is described as a risk factor to develop severe COVID-19 infection. Sepsis is associated with a major systemic inflammatory response with an increased production of pro-inflammatory cytokines. Since their discovery, inflammasomes have an important role during inflammatory response following an aggression. There are intracytoplasmic multiprotein complex activated by cellular stress or infections and is responsible for the release of pro-inflammatory cytokines, including IL-1β. Most studies have analysed inflammasomes in nucleated cells, nevertheless, little is known about inflammasomes in platelets. Thus, the present work aims to study the activation of the platelet NLRP3 inflammasome and the platelet functions and coagulation during a SARS-CoV-2 viral pneumonia according to different levels of severity

Official Title
-----------------
Study of INFLAmmasome NLRP3 and PLAtelets Functions During Severe COVID-19 Infection

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

Intervention / Treatment
-----------------
* Biological: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from COVID-19, hospitalized in intensive care unit and in standard care unit. Exclusion Criteria: Patients suffering from malignant blood disease, cryopyrinopathy, sickle cell disease, rheumatoid arthritis and Crohn's disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 GROUP Intensive care unit<br>Patients suffering from COVID-19 hospitalized in intensive care unit | Biological: Blood samples<br>* Blood samples will be collected in peripheral blood at the admission in intensive care unit or in standard care unit to compare platelet inflammasome NLRP3 and others markers<br>|
| COVID-19 GROUP Standard care unit<br>Patients suffering from COVID-19 hospitalized in standard care unit. | Biological: Blood samples<br>* Blood samples will be collected in peripheral blood at the admission in intensive care unit or in standard care unit to compare platelet inflammasome NLRP3 and others markers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation of platelet NLRP3 inflammasome | Caspase-1 activity analyzed in patients in intensive care unit and in patients in standard care unit. | Day 0 During resuscitation (Covid-19 Resuscitation) or hospitalization (Covid-19 No Resuscitation) | 
| Activation of platelet NLRP3 inflammasome | Labeling NOD-like receptor protein 3 (NLRP3)/Adaptor protein apoptosis-associated speck-like protein containing a CARD (ASC) analyzed in patients in intensive care unit and in patients in standard care unit. | During Day 0 During resuscitation (Covid-19 Resuscitation) or hospitalization (Covid-19 No Resuscitation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, NLRP3 inflammasome, Platelets functions, Coagulopathy, Acute respiratory distress syndrome