Back to resultsHLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment (HLA-G-COVID)
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Baseline and during hospitalization blood samples
Baseline blood sample
Sponsored by
About this trial
This is an interventional other trial for Covid19 focused on measuring HLA-G
Eligibility Criteria
Inclusion Criteria:
- Patient with possible or confirmed infection by COVID-19
Exclusion Criteria:
- Patient without liberty or guardianship
Sites / Locations
- Foch hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
COVID-19 uninfected patients
non-hospitalized COVID-19 infected patients
hospitalized COVID-19 infected patients
Arm Description
Patient with negative PCR result
Patient with positive PCR result who does not require hospitalization for COVID-19
Patient with positive PCR who require hospitalization for COVID-19
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
1 month survival
Vital status collected 1 month post inclusion for all the patients
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04613297
Brief Title
HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment
Acronym
HLA-G-COVID
Official Title
HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
July 19, 2022 (Actual)
Study Completion Date
July 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
HLA-G
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID-19 uninfected patients
Arm Type
Other
Arm Description
Patient with negative PCR result
Arm Title
non-hospitalized COVID-19 infected patients
Arm Type
Other
Arm Description
Patient with positive PCR result who does not require hospitalization for COVID-19
Arm Title
hospitalized COVID-19 infected patients
Arm Type
Other
Arm Description
Patient with positive PCR who require hospitalization for COVID-19
Intervention Type
Other
Intervention Name(s)
Baseline and during hospitalization blood samples
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Baseline blood sample
Intervention Description
Blood sample will be performed at the inclusion visit only
Primary Outcome Measure Information:
Title
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.
Description
The CD3 + T lymphocyte cell populations (CD4 + ILT2 + and CD8 + ILT2 +) will be compared between the groups of patients
Time Frame
1 month
Title
Comparison of the expression of circulating soluble HLA-G, between the groups of patients.
Description
Blood levels of soluble HLA-G and plasma microvesicles with expression of HLA-G will be compared between the groups of patients.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
1 month survival
Description
Vital status collected 1 month post inclusion for all the patients
Time Frame
1 month
Title
Assessment of the severity of the disease according to the isoform of HLA-G
Description
Comparison of the isoforms (alleles) of HLA-G regarding the severity of the disease for the infected patients.
Time Frame
1 month
Title
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.
Description
The expression of the BSG cell receptor induced by HLA-G will be compared between COVID19 patients and uninfected patients.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with possible or confirmed infection by COVID-19
Exclusion Criteria:
Patient without liberty or guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier BRUGIERE, PhD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foch hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment
We'll reach out to this number within 24 hrs