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

Completed

• Conditions: COVID-19

• Registration Number: NCT04379466
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-07
• Study Start: 2020-05-11
• Primary Completion: 2021-01-27
• Study Completion: 2021-01-27
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A list of COVID-19 specific TCR sequences	at day1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Pitie Salpétrère; 🇫🇷 Paris, France