Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe

NCT ID: NCT04397237

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2021-01-31

Brief Summary

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The coronavirus disease 2019 (COVID-19) pandemic is a potentially fatal disease that represents a great global public health concern. In European countries such as Spain, Italy, Germany, Portugal, England and France, the pandemic has been of utmost importance. To date, no treatment has been robustly validated, and two theoretically opposite therapeutic strategies are proposed, based either on antiretroviral therapy or on immunomodulating agents.

In this complex context, people living with immune-mediated inflammatory diseases (IMID) raise specific concerns due to their potentially increased risk of infections or of severe infections. Among IMID, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis are some key diseases.

In this cross-sectional, observational, multi-centric study, the investigators aim to assess both clinical and serological prevalence of COVID-19 among samples of IMID patients in Europe. In parallel, the investigators aim to compare the prevalence of COVID-19 seroconversion across these five IMIDs, their penetration across different 6 European countries (France, Italy, Spain, Germany, United Kingdom and Portugal), and to assess the severity of COVID-19 in these patients. Moreover, changes in treatment will be assessed, including immunomodulatory tapering or discontinuation, its causes over the outbreak period, as well as the incidence of IMID flares and their severity over this same period. Finally, patient's perceptions towards the pandemic will be evaluated and compared to medication beliefs.

Data will be collected through questionnaires during medical visit or phone consultation and serological tests will be performed within routine blood collection. As so, all study procedures are comprised within usual care. Through this study the investigators expect to have a better knowledge of the clinical and serological prevalence of COVID-19 in IMID across Europe, along with the psychological, clinical, and therapeutic impact of COVID-19 in this particular patient population.

Detailed Description

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Conditions

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COVID-19 Systemic Lupus Erythematosus Sjogren's Syndrome Axial Spondyloarthritis Rheumatoid Arthritis Giant Cell Arteritis

Keywords

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COVID-19 Systemic Lupus Erythematosus Sjogren's Syndrome Axial Spondyloarthritis Rheumatoid Arthritis Giant Cell Arteritis Prevalence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Systemic Lupus Erythematosus

Consecutive Systemic Lupus Erythematosus patients followed-up in each service

No interventions assigned to this group

Sjogren's Syndrome

Consecutive Sjogren's Syndrome patients followed-up in each service

No interventions assigned to this group

Axial Spondyloarthritis

Consecutive Axial Spondyloarthritis patients followed-up in each service

No interventions assigned to this group

Rheumatoid Arthritis

Consecutive Rheumatoid Arthritis patients followed-up in each service

No interventions assigned to this group

Giant Cell Arteritis

Consecutive Giant Cell Arteritis patients followed-up in each service

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years;
* Patients fitting classification criteria for each IMID (i.e., Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, axial spondyloarthritis or giant cell arteritis);
* Willingness to participate;

Exclusion Criteria

* Patients who refuse to participate;
* Patients who don't speak or read the local language,
* Patients unable to perform a routine blood collection during the study period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role collaborator

Rheumazentrum Ruhrgebiet

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

University of Coimbra

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role collaborator

Pitié-Salpêtrière Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pr David Saadoun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Saadoun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pitié-Salpêtrière Hospital

Locations

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Saadoun

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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Pope JE. What Does the COVID-19 Pandemic Mean for Rheumatology Patients? Curr Treatm Opt Rheumatol. 2020;6(2):71-74. doi: 10.1007/s40674-020-00145-y. Epub 2020 Apr 30.

Reference Type BACKGROUND
PMID: 32355607 (View on PubMed)

Favalli EG, Agape E, Caporali R. Incidence and Clinical Course of COVID-19 in Patients with Connective Tissue Diseases: A Descriptive Observational Analysis. J Rheumatol. 2020 Aug 1;47(8):1296. doi: 10.3899/jrheum.200507. Epub 2020 Apr 25. No abstract available.

Reference Type BACKGROUND
PMID: 32335513 (View on PubMed)

Mathian A, Mahevas M, Rohmer J, Roumier M, Cohen-Aubart F, Amador-Borrero B, Barrelet A, Chauvet C, Chazal T, Delahousse M, Devaux M, Euvrard R, Fadlallah J, Florens N, Haroche J, Hie M, Juillard L, Lhote R, Maillet T, Richard-Colmant G, Palluy JB, Pha M, Perard L, Remy P, Riviere E, Sene D, Seve P, Morelot-Panzini C, Viallard JF, Virot JS, Benameur N, Zahr N, Yssel H, Godeau B, Amoura Z. Clinical course of coronavirus disease 2019 (COVID-19) in a series of 17 patients with systemic lupus erythematosus under long-term treatment with hydroxychloroquine. Ann Rheum Dis. 2020 Jun;79(6):837-839. doi: 10.1136/annrheumdis-2020-217566. Epub 2020 Apr 24. No abstract available.

Reference Type BACKGROUND
PMID: 32332072 (View on PubMed)

Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020 May;79(5):667-668. doi: 10.1136/annrheumdis-2020-217424. Epub 2020 Apr 2. No abstract available.

Reference Type BACKGROUND
PMID: 32241793 (View on PubMed)

Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3. Epub 2020 Apr 16. No abstract available.

Reference Type BACKGROUND
PMID: 32309814 (View on PubMed)

Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.

Reference Type BACKGROUND
PMID: 32226353 (View on PubMed)

Saadoun D, Vieira M, Vautier M, Baraliakos X, Andreica I, da Silva JAP, Sousa M, Luis M, Khmelinskii N, Gracia JMA, Castrejon I, Gonzalez JCN, Scire CA, Silvagni E, Bortoluzzi A, Penn H, Hamdulay S, Machado PM, Fautrel B, Cacoub P, Resche-Rigon M, Gossec L. SARS-CoV-2 outbreak in immune-mediated inflammatory diseases: the Euro-COVIMID multicentre cross-sectional study. Lancet Rheumatol. 2021 Jul;3(7):e481-e488. doi: 10.1016/S2665-9913(21)00112-0. Epub 2021 Apr 28.

Reference Type DERIVED
PMID: 33942031 (View on PubMed)

Other Identifiers

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2020-A01371-38

Identifier Type: -

Identifier Source: org_study_id