HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Foch
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with possible or confirmed infection by COVID-19
Exclusion Criteria
- •Patient without liberty or guardianship
Arms & Interventions
COVID-19 uninfected patients
Patient with negative PCR result
Intervention: Baseline blood sample (Other)
non-hospitalized COVID-19 infected patients
Patient with positive PCR result who does not require hospitalization for COVID-19
Intervention: Baseline blood sample (Other)
hospitalized COVID-19 infected patients
Patient with positive PCR who require hospitalization for COVID-19
Intervention: Baseline and during hospitalization blood samples (Other)
Outcomes
Primary Outcomes
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.
Time Frame: 1 month
The CD3 + T lymphocyte cell populations (CD4 + ILT2 + and CD8 + ILT2 +) will be compared between the groups of patients
Comparison of the expression of circulating soluble HLA-G, between the groups of patients.
Time Frame: 1 day
Blood levels of soluble HLA-G and plasma microvesicles with expression of HLA-G will be compared between the groups of patients.
Secondary Outcomes
- 1 month survival(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.(1 day)
- Assessment of the severity of the disease according to the isoform of HLA-G(1 month)