HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment
HLA-G-COVID
1 other identifier
interventional
91
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Oct 2020
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2020
CompletedFirst Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2022
CompletedAugust 3, 2022
August 1, 2022
1.7 years
November 2, 2020
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
1 month survival
1 month
Assessment of the severity of the disease according to the isoform of HLA-G
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
Study Arms (3)
COVID-19 uninfected patients
OTHERPatient with negative PCR result
non-hospitalized COVID-19 infected patients
OTHERPatient with positive PCR result who does not require hospitalization for COVID-19
hospitalized COVID-19 infected patients
OTHERPatient with positive PCR who require hospitalization for COVID-19
Interventions
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
Blood sample will be performed at the inclusion visit only
Eligibility Criteria
You may qualify if:
- Patient with possible or confirmed infection by COVID-19
You may not qualify if:
- Patient without liberty or guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Foch hospital
Suresnes, 92151, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier BRUGIERE, PhD
Hopital Foch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 3, 2020
Study Start
October 19, 2020
Primary Completion
July 19, 2022
Study Completion
July 19, 2022
Last Updated
August 3, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share