HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment

Study Overview
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Brief Summary
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The aim of the research is to study the immune checkpoint linked to the HLA-G molecule in the dysregulation of the control of COVID-19 infection.

Detailed Description
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Single-center, prospective, open-ended, interventional study with minimal risks and constraints. Patients will be divided into 3 groups: patients not infected with COVID-19, patients infected with COVID-19 not hospitalized, patients infected with COVID-19 hospitalized.

Official Title
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HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment

Conditions
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Covid19

Intervention / Treatment
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* Other: Baseline and during hospitalization blood samples
* Other: Baseline blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with possible or confirmed infection by COVID-19 Exclusion Criteria: Patient without liberty or guardianship

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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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COVID-19 uninfected patients<br>Patient with negative PCR result | Other: Baseline blood sample<br>* Blood sample will be performed at the inclusion visit only<br>|
| Other: non-hospitalized COVID-19 infected patients<br>Patient with positive PCR result who does not require hospitalization for COVID-19 | Other: Baseline blood sample<br>* Blood sample will be performed at the inclusion visit only<br>|
| Other: hospitalized COVID-19 infected patients<br>Patient with positive PCR who require hospitalization for COVID-19 | Other: Baseline and during hospitalization blood samples<br>* Blood sample will be performed at the inclusion visit for all patient and for the hospitalized COVID-19 infected patients, extra-blood samples will be performed : at day 3 day 5 and In case of aggravation At the discharge from hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the percentage of T cells expressing the HLA-G receptor ILT2 (CD3+CD4+ILT2+ T cells, and CD3+CD8+ILT2+ T cells) between the 3 groups of patients. | The CD3 + T lymphocyte cell populations (CD4 + ILT2 + and CD8 + ILT2 +) will be compared between the groups of patients | 1 month | 
| Comparison of the expression of circulating soluble HLA-G, between the groups of patients. | Blood levels of soluble HLA-G and plasma microvesicles with expression of HLA-G will be compared between the groups of patients. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 month survival | Vital status collected 1 month post inclusion for all the patients | 1 month | 
| Assessment of the severity of the disease according to the isoform of HLA-G | Comparison of the isoforms (alleles) of HLA-G regarding the severity of the disease for the infected patients. | 1 month | 
| Comparison of the expression of one of the cell receptors of the SARS-CoV-2 virus, called BSG (Basigin), whose expression is modified by the interaction between HLA-G. | The expression of the BSG cell receptor induced by HLA-G will be compared between COVID19 patients and uninfected patients. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HLA-G