Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19

Study Overview
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Brief Summary
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The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.

Detailed Description
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This is a non-interventional transversal research whose main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19. Design: A multicentric (3 sites) clinical trial Sample size : 200 patients Population concerned: Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab. Duration of participation (treatment + follow-up): until the patient is discharged from the ICU and within 2 months top. No interim analysis is planned. Analysis will be performed at the end of the study.

Official Title
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Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19

Conditions
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Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to the intensive care units of Saint-Antoine, Tenon and Pitié-Salpêtrière hospitals (Paris, France) With moderate to severe respiratory distress syndrome and SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab informed and not opposed to participation in research included within 4 hours following the paatient's admission Exclusion Criteria: Patients under guardianship / curatorship Patients under AME
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 |
| --- | --- |
| Patients with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.<br>Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of circulating neutrophils in reverse migration | Percentage of circulating neutrophils in reverse migration determined on a sample taken during the admission of COVID 19 patients to Intensive Care Units by flow cytometry: the samples will be incubated for 45 minutes with anti-human CXCR1, CD11c, CD11b, and CD62L antibodies. Erythrocytes will be lysed and fixed leukocytes will be analyzed by flow cytometry. | Within 4 hours following the patient admission in Intensive Care Units (ICU). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of neutrophils and platelets | The analysis of neutrophils and platelets, and of the inflammatory environment will be carried out on a sample taken on admission of patients to Intensive Care Units Phenotypic and functional analysis of neutrophils Measurement of the oxidative explosion Measurement of neutrophil apoptosis Measurement of intravascular NETosis Analysis of platelet aggregation and activation Quantification of the fraction of immature platelets (IPF) Contribution of platelets to clot stiffness ELISA assay of soluble platelet activation markers Measurement of D-Dimers, von Willebrand factor, thrombin-antithrombin complex (TAT), α2-Plasmin-Plasmin-inhibitor | Within 4 hours following the patient admission in Intensive Care Units (ICU). | 
| SAPS II score | Assessment of the link between phenotypic and functional markers of neutrophils on admission to the ICU. The severity of the disease is determined using clinical scores (SAPS II (simplified acute physiology) and SOFA (Sequential Organ Failure Assessment) (global SOFA, respiratory and non-respiratory) scores; these scores will be assessed during the period of hospitalization in Intensive Care Units. An association between these 2 scores (SAPSII and SOFA scores) and the neutrophil markers will be sought. | From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top). | 
| SOFA score | Assessment of the link between phenotypic and functional markers of neutrophils on admission to the ICU. The severity of the disease is determined using clinical scores (SAPS II (simplified acute physiology) and SOFA (Sequential Organ Failure Assessment) (global SOFA, respiratory and non-respiratory) scores; these scores will be assessed during the period of hospitalization in Intensive Care Units. An association between these 2 scores (SAPSII and SOFA scores) and the neutrophil markers will be sought. | From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top). | 
| Mortality rate | The mortality occurring within 2 months of admission of patients to an ICU will also be assessed. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical scores, Covid19, Neutrophils, Platelet aggregation activation, SAPS II (simplified acute physiology), SOFA (Sequential Organ Failure Assessment), Global respiratory and non-respiratory scores