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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04379466

Acronym

CovRep

Enrollment

Registered

2020-05-07

Start date

2020-05-11

Completion date

2021-01-27

Last updated

2022-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, T cell receptor, Effector T cells, Regulatory T cells, Single cell sequencing, Modelisation, Pathophysiology, Biomarkers

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
A list of COVID-19 specific TCR sequences	at day1

Secondary

Measure	Time frame
One or more measures from peripheral blood immunophenotyping that is/are associated with COVID-19 outcome	at day1
Group of COVID-19 specific TCR sequences that is associated with COVID-19 outcome	at day1

Countries

France

Outcome results