CovRep: Effector and Regulatory T Cell Receptor Repertoire Analyses in Patients Affected by COVID-19

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT04379466
Collaborator
(none)
58
1
8.6
6.8

Study Details

Study Description

Brief Summary

The specificity of the adaptive immune response (AIR), and its balance between effector T cells (Teffs) and regulatory T cells (Tregs), is most likely a major determinant of the outcome of a Covid-19 infection.

We aim to analyze (i) the cellular components and (ii) the specificity of the AIR to COVID-19 in 60 patients with moderate and severe form of the disease. This should have important implications for (i) understanding the pathophysiology of the disease, (ii) discovering biomarkers of severity and (iii) designing treatments and vaccines.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The quality of the adaptive immune response (AIR) to COVID-19 probably determines the course of the disease. Therefore, a comprehensive knowledge of the immune response to COVID-19 is required to better anticipate its outcome and identify vaccine targets. In particular, the quality of an AIR can be investigated by immunophenotyping (enumerating immune cells and assessing their fitness) and by analyzing the T cell receptor (TCR) repertoire.

    The cellular components of the AIR will be analyzed by a deep immunophenotyping generating

    800 measures assessing immune cells quantitatively and qualitatively (Pitoiset et al.,2018). Combined with supervised and unsupervised analyses, it has the power to detect subtle/hidden abnormalities.

    The specificity will be analyzed by studying the global T cell receptor (TCR) repertoire of separated Tregs and Teffs from peripheral blood, as well as by single cell sequencing of cells from bronchoalveolar lavages.

    These combined approaches should uncover parameters/abnormalities of the AIR linked to the infection severity and outcome, and lead to a better understanding of the nature of the Tregs and Teffs repertoires against COVID-19. This will have important implications for (i) understanding the pathophysiology of the disease, (ii) discovering biomarkers of severity and (iii) designing treatments and vaccines.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    58 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effector and Regulatory T Cell Receptor Repertoire Analyses in Patients Affected by COVID-19
    Actual Study Start Date :
    May 11, 2020
    Actual Primary Completion Date :
    Jan 27, 2021
    Actual Study Completion Date :
    Jan 27, 2021

    Outcome Measures

    Primary Outcome Measures

    1. A list of COVID-19 specific TCR sequences [at day1]

    Secondary Outcome Measures

    1. One or more measures from peripheral blood immunophenotyping that is/are associated with COVID-19 outcome [at day1]

    2. Group of COVID-19 specific TCR sequences that is associated with COVID-19 outcome [at day1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria :
    • Age≥18 and ≤75 years

    • Presenting a confirmed diagnosis of COVID-19 disease in accordance with WHO diagnostic criteria;

    • Good venous capital ;

    • Affiliation to a social security system;

    • Having declared his/her non-opposition to participation in research (for patients hospitalized in intensive care units who are not able to communicate, the non-opposition of a trusted person will be sought.)

    Exclusion criteria :
    • Still under the exclusion period from another biomedical study

    • Psychiatric illness or addiction that could interfere with the ability to comply with the requirements of the protocol or to give consent to participate in the study;

    • Patient benefiting from a legal protection measure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Pitie Salpétrère Paris France 75013

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: David KLATZMANN, MD, PhD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04379466
    Other Study ID Numbers:
    • APHP200544
    • 2020-A01245-34
    First Posted:
    May 7, 2020
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 13, 2022