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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
COVID-19

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.

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Study Type : Observational
Estimated Enrollment : 60 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 5, 2020
Estimated Primary Completion Date : October 11, 2020
Estimated Study Completion Date : April 2021



Primary Outcome Measures :
  1. A list of COVID-19 specific TCR sequences [ Time Frame: at day1 ]

Secondary Outcome Measures :
  1. One or more measures from peripheral blood immunophenotyping that is/are associated with COVID-19 outcome [ Time Frame: at day1 ]
  2. Group of COVID-19 specific TCR sequences that is associated with COVID-19 outcome [ Time Frame: at day1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men or women, aged 18 to 75, infected with SARS-CoV-2 and admitted to the Pitié-Salpêtrière hospital for treatment
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: David KLATZMANN, MD, PhD +33 1 42 17 74 61 david.klatzmann@sorbonne-universite.fr
Contact: Roberta LORENZON, MD +33142176516 roberta.lorenzon@sorbonne-universite.fr

Locations
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France
Hôpital Pitie Salpétrère Recruiting
Paris, France, 75013
Contact: Jean Michel CONSTANTIN, PH-PI         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: David KLATZMANN, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04379466    
Other Study ID Numbers: APHP200544
2020-A01245-34 ( Other Identifier: IDRCB )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020

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