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

Covid19 Clinical Trial

— HLA-G-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613297
• Other study ID #: 2020_0082
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: July 19, 2022

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with possible or confirmed infection by COVID-19

Exclusion Criteria:

• Patient without liberty or guardianship

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Baseline and during hospitalization blood samples
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
• Baseline blood sample
Blood sample will be performed at the inclusion visit only

Locations

Country	Name	City	State
France	Foch hospital	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	1 month survival	Vital status collected 1 month post inclusion for all the patients	1 month
Secondary	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
Secondary	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