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SARS-Cov-2 InfectionSENO-COVIDNCT04880720

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

An observational study of SARS-Cov-2 Infection and Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-Cov-2 Infection, Rheumatoid Arthritis
What is being tested?
Blood sampling
How many people
43 participants
Where
1 siteFrance
Study dates
19 Jul 2021to 16 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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)

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Montpellier

    Montpellier, 34080

Other trials in France

About this study

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.

Being tested
Blood sampling
Medical subject headings
COVID-19, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04880720
Study groupRoleWhat they receive
COVID-19 PatientsNot described
Receives: Other: Blood sampling
Rheumatoid Arthritis PatientsNot described
Receives: Other: Blood sampling
Healthy ComparatorNot described
Receives: Other: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Results of phenotypic immunosenescence analyses of COVID-19 patients targeting 5 different immune populations (neutrophils, T lymphocytes, NK lymphocytes, B lymphocytes and monocytes).

    Measured: At inclusion visit

Secondary outcomes (3)

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

    Measured: At inclusion visit

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

    Measured: 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.

    Measured: At inclusion visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start19 Jul 2021
  3. Primary completion16 May 2022
  4. Study completion16 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04880720
Sponsor's protocol ID
RECHMPL20_0454
Acronym
SENO-COVID
Status last verified
Jan 2023
First submitted
10 May 2021
Last updated
5 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang R, Pan M, Zhang X, Han M, Fan X, Zhao F, Miao M, Xu J, Guan M, Deng X, Chen X, Shen L. Epidemiological and clinical features of 125 Hospitalized Patients with COVID-19 in Fuyang, Anhui, China. Int J Infect Dis. 2020 Jun;95:421-428. doi: 10.1016/j.ijid.2020.03.070. Epub 2020 Apr 11.

    PubMed 32289565

  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

    PubMed 32091533

  • Li X, Xu S, Yu M, Wang K, Tao Y, Zhou Y, Shi J, Zhou M, Wu B, Yang Z, Zhang C, Yue J, Zhang Z, Renz H, Liu X, Xie J, Xie M, Zhao J. Risk factors for severity and mortality in adult COVID-19 inpatients in Wuhan. J Allergy Clin Immunol. 2020 Jul;146(1):110-118. doi: 10.1016/j.jaci.2020.04.006. Epub 2020 Apr 12.

    PubMed 32294485

  • Rockx B, Baas T, Zornetzer GA, Haagmans B, Sheahan T, Frieman M, Dyer MD, Teal TH, Proll S, van den Brand J, Baric R, Katze MG. Early upregulation of acute respiratory distress syndrome-associated cytokines promotes lethal disease in an aged-mouse model of severe acute respiratory syndrome coronavirus infection. J Virol. 2009 Jul;83(14):7062-74. doi: 10.1128/JVI.00127-09. Epub 2009 May 6.

    PubMed 19420084

  • Maringer K, Fernandez-Sesma A. Message in a bottle: lessons learned from antagonism of STING signalling during RNA virus infection. Cytokine Growth Factor Rev. 2014 Dec;25(6):669-79. doi: 10.1016/j.cytogfr.2014.08.004. Epub 2014 Aug 24.

    PubMed 25212897

  • Nikolich-Zugich J. The twilight of immunity: emerging concepts in aging of the immune system. Nat Immunol. 2018 Jan;19(1):10-19. doi: 10.1038/s41590-017-0006-x. Epub 2017 Dec 14.

    PubMed 29242543

  • Fulop T, Larbi A, Dupuis G, Le Page A, Frost EH, Cohen AA, Witkowski JM, Franceschi C. Immunosenescence and Inflamm-Aging As Two Sides of the Same Coin: Friends or Foes? Front Immunol. 2018 Jan 10;8:1960. doi: 10.3389/fimmu.2017.01960. eCollection 2017.

    PubMed 29375577

  • Tachikart Y, Malaise O, Mumme M, Jorgensen C, Brondello JM. Seno-suppressive molecules as new therapeutic perspectives in rheumatic diseases. Biochem Pharmacol. 2019 Jul;165:126-133. doi: 10.1016/j.bcp.2019.03.017. Epub 2019 Mar 13.

    PubMed 30878551

  • Oh SJ, Lee JK, Shin OS. Aging and the Immune System: the Impact of Immunosenescence on Viral Infection, Immunity and Vaccine Immunogenicity. Immune Netw. 2019 Nov 14;19(6):e37. doi: 10.4110/in.2019.19.e37. eCollection 2019 Dec.

    PubMed 31921467

  • Vicente R, Mausset-Bonnefont AL, Jorgensen C, Louis-Plence P, Brondello JM. Cellular senescence impact on immune cell fate and function. Aging Cell. 2016 Jun;15(3):400-6. doi: 10.1111/acel.12455. Epub 2016 Feb 22.

    PubMed 26910559

  • Campos C, Pera A, Sanchez-Correa B, Alonso C, Lopez-Fernandez I, Morgado S, Tarazona R, Solana R. Effect of age and CMV on NK cell subpopulations. Exp Gerontol. 2014 Jun;54:130-7. doi: 10.1016/j.exger.2014.01.008. Epub 2014 Jan 17.

    PubMed 24440462

  • Appay V, Almeida JR, Sauce D, Autran B, Papagno L. Accelerated immune senescence and HIV-1 infection. Exp Gerontol. 2007 May;42(5):432-7. doi: 10.1016/j.exger.2006.12.003. Epub 2007 Jan 8.

    PubMed 17307327

  • Goronzy JJ, Lee WW, Weyand CM. Aging and T-cell diversity. Exp Gerontol. 2007 May;42(5):400-6. doi: 10.1016/j.exger.2006.11.016. Epub 2007 Jan 10.

    PubMed 17218073

  • Lin L, Lu L, Cao W, Li T. Hypothesis for potential pathogenesis of SARS-CoV-2 infection-a review of immune changes in patients with viral pneumonia. Emerg Microbes Infect. 2020 Dec;9(1):727-732. doi: 10.1080/22221751.2020.1746199.

    PubMed 32196410

  • de Wit E, van Doremalen N, Falzarano D, Munster VJ. SARS and MERS: recent insights into emerging coronaviruses. Nat Rev Microbiol. 2016 Aug;14(8):523-34. doi: 10.1038/nrmicro.2016.81. Epub 2016 Jun 27.

    PubMed 27344959

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-Cov-2 Infection and Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04880720, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.

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