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

August 2, 2022 updated by: Hopital Foch
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92151
        • Foch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with possible or confirmed infection by COVID-19

Exclusion Criteria:

  • Patient without liberty or guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: COVID-19 uninfected patients
Patient with negative PCR result
Other: Baseline blood sample
Blood sample will be performed at the inclusion visit only
Other: non-hospitalized COVID-19 infected patients
Patient with positive PCR result who does not require hospitalization for COVID-19
Other: Baseline blood sample
Blood sample will be performed at the inclusion visit only
Other: hospitalized COVID-19 infected patients
Patient with positive PCR who require hospitalization for COVID-19
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

What is the study measuring?

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.
Time Frame: 1 month
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.
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 month survival
Time Frame: 1 month
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
Time Frame: 1 month
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.
Time Frame: 1 day
The expression of the BSG cell receptor induced by HLA-G will be compared between COVID19 patients and uninfected patients.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Olivier BRUGIERE, PhD, Hôpital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Actual)

July 19, 2022

Study Completion (Actual)

July 19, 2022

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_0082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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