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

NCT04880720 | Completed

• 1 other identifier: RECHMPL20_0454
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-Cov-2 Infection; Rheumatoid Arthritis

Outcome Measures

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).

  At inclusion visit

Secondary Outcomes (3)

• Comparison of previous results with the results of senescence immunophenotyping in peripheral blood of a reference population with an inflammatory disease (active RA)

  At inclusion visit

• Comparison of previous results with the results of senescence immunophenotyping in peripheral blood of a reference population of healthy controls.

  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.

  At inclusion visit

Study Arms (3)

COVID-19 Patients

Other: Blood sampling

Rheumatoid Arthritis Patients

Other: Blood sampling

Healthy Comparator

Other: Blood sampling

Interventions

Blood sampling OTHER

Blood sampling - 10mL

COVID-19 Patients; Healthy Comparator; Rheumatoid Arthritis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• Subjects under 18 years of age
• HIV positive patients
• Diabetic patients
• Morbidly obese patients (BMI \> 40kg/m2)
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34080, France

Location

Related Publications (25)

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MeSH Terms

Conditions

COVID-19; Arthritis, Rheumatoid

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 11, 2021
• Study Start: July 19, 2021
• Primary Completion: May 16, 2022
• Study Completion: November 16, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

FR (1)