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

Rheumatoid Arthritis Clinical Trial

— SENO-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880720
• Other study ID #: RECHMPL20_0454
• Status: Completed
• Start date: July 19, 2021
• Est. completion date: November 16, 2022

Study information

• Verified date: January 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• COVID-19
• Rheumatoid Arthritis
• SARS-Cov-2 Infection

Intervention

Other:
• Blood sampling
Blood sampling - 10mL

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Comparison of previous results with the results of senescence immunophenotyping in peripheral blood of a reference population of healthy controls.		At inclusion visit
Secondary	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