Deciphering a Specific Signature of the Immunosenescence Induced in COVID-19+ Patients Versus Rheumatoid Arthritis Patients (SENO-COVID)

January 4, 2023 updated by: University Hospital, Montpellier
Immune aging or immunosenescence is characterized by a loss of T cell clonal diversity and a contraction of naïve T cells with proliferative capacity associated with the functional impairment of many others immune cells as well as a chronic low degree of inflammation. A restrictive T cell repertoire is likely more prone to antigen-mediated exhaustion observed during chronic viral infections. Notably, lymphopenia is the most consistent laboratory abnormality in COVID-19 infected patients and both lung-resident and circulating T cells potently up-regulate markers of T cell exhaustion. It is not clear today if the association of COVID-19 disease severity with age is mainly related with the immunosenescence of infected patients. Interestingly, T cell exhaustion and premature immunosenescence have also been observed in chronic inflammatory diseases such as rheumatoid arthritis (RA). To better understand the immunological mechanisms involved in SARS-Cov-2 pathophysiology, the investigators propose to compare the immunosenescence patterns observed during RA, aging and SARS-Cov-2 infected patients in order to design improved therapeutic interventions.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montpellier, France, 34080
        • CHU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • COVID-19 patients are recruited through the Covidothèque project and the UANDES center (Chile)
  • RA patients and healthy subjects are recruited through 3 rheumatology reference centers (Montpellier, Paris Saint-Antoine and Saint-Etienne)

Description

Inclusion Criteria for Active RA Patients:

  • Patients with rheumatoid arthritis (RA) meeting the 2010 ACR/EULAR diagnostic criteria
  • Patients in inflammatory flare of RA (DAS28 > 3.2)
  • Patients who have been off biological disease-modifying antirheumatic drugs (bDMARDs) or targeted synthetic antirheumatic drugs (tsDMARDs) for RA for at least 2 weeks (except for rituximab, where a delay of at least 12 months is required)
  • Conventional synthetic DMARDs (Methotrexate, Hydroxychloroquine, Leflunomide, Sulfasalazine) are allowed
  • Beneficiary of a social security system
  • Informed consent

Inclusion Criteria for Healthy Controls:

  • Absence of chronic diseases and current infection
  • Beneficiary of a social security system
  • Informed consent

Inclusion Criteria for COVID-19+ Patients:

  • Patients with ongoing SARS-Cov-2 infection (PCR+)
  • Patients hospitalized at D7-D14 of symptoms onset
  • Patients with two or more SARS-Cov-2 symptoms (including fever, cough, dyspnea, sore throat, chest pain, anosmia, diarrhea)
  • Membership in or beneficiary of a social security scheme
  • Collection of free and informed consent

Exclusion Criteria for All Groups:

  • Subjects under 18 years of age
  • HIV positive patients
  • Diabetic patients
  • Morbidly obese patients (BMI > 40kg/m2)
  • Use of senolytic drugs in the week prior to inclusion (azithromycin, metformin, cyclosporine, JAK inhibitors)
  • Use of steroids in doses greater than 10 mg/day in the week prior to inclusion
  • Subjects unable to give consent
  • Pregnant, breastfeeding, or non-menopausal women not taking effective contraception
  • Vulnerable subjects protected by law
  • Subjects under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 Patients
Blood sampling - 10mL
Rheumatoid Arthritis Patients
Blood sampling - 10mL
Healthy Comparator
Blood sampling - 10mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Results of phenotypic immunosenescence analyses of COVID-19 patients targeting 5 different immune populations (neutrophils, T lymphocytes, NK lymphocytes, B lymphocytes and monocytes).
Time Frame: At inclusion visit
At inclusion visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of previous results with the results of senescence immunophenotyping in peripheral blood of a reference population with an inflammatory disease (active RA)
Time Frame: At inclusion visit
At inclusion visit
Comparison of previous results with the results of senescence immunophenotyping in peripheral blood of a reference population of healthy controls.
Time Frame: At inclusion visit
At inclusion visit
Identification of a specific gene expression of immunosenescence induced in COVID-19 patients, using transcriptomic analysis in the different immune subpopulations previously identified and specific to COVID-19 patients.
Time Frame: At inclusion visit
At inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2021

Primary Completion (Actual)

May 16, 2022

Study Completion (Actual)

November 16, 2022

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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