Effector and Regulatory T Cell Receptor Repertoire Analyses in Patients Affected by COVID-19 (CovRep)
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|ClinicalTrials.gov Identifier: NCT04379466|
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : August 18, 2020
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|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Effector and Regulatory T Cell Receptor Repertoire Analyses in Patients Affected by COVID-19|
|Actual Study Start Date :||May 5, 2020|
|Estimated Primary Completion Date :||October 11, 2020|
|Estimated Study Completion Date :||April 2021|
- A list of COVID-19 specific TCR sequences [ Time Frame: at day1 ]
- One or more measures from peripheral blood immunophenotyping that is/are associated with COVID-19 outcome [ Time Frame: at day1 ]
- Group of COVID-19 specific TCR sequences that is associated with COVID-19 outcome [ Time Frame: at day1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379466
|Contact: David KLATZMANN, MD, PhD||+33 1 42 17 74 firstname.lastname@example.org|
|Contact: Roberta LORENZON, MDemail@example.com|
|Hôpital Pitie Salpétrère||Recruiting|
|Paris, France, 75013|
|Contact: Jean Michel CONSTANTIN, PH-PI|
|Principal Investigator:||David KLATZMANN, MD, PhD||Assistance Publique - Hôpitaux de Paris|