Skip to main content
OpenTrials
Completed

NCT Number: NCT04613297

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foch hospital

Suresnes, 92151, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with possible or confirmed infection by COVID-19

Exclusion criteria

  • Patient without liberty or guardianship

Treatment and study plan

Baseline and during hospitalization blood samples

Other

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

Other

Blood sample will be performed at the inclusion visit only

Primary outcomes

  1. 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

  2. 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. 1 month survival

    Time frame: 1 month

    Vital status collected 1 month post inclusion for all the patients

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: HLA-G-COVID

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2020
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.