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OpenTrials
Completed

NCT Number: NCT04880720

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

Blood sampling - 10mL

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: SENO-COVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 11, 2021
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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