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

NCT04397237 | Unknown

• 1 other identifier: 2020-A01371-38
• Study Type: observational
• Target: 3,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• COVID-19 seroconversion

  ELISA tests for COVID-19 antibodies

  1 day, during routine blood collection

• COVID-19 infection

  Case report form filled by the health professional

  During medical visit or phone consultation, up to 2 hours

Secondary Outcomes (8)

• Seroconversion rate by disease

  1 day, during routine blood collection

• Penetration across Europe

  1 day, during routine blood collection

• COVID-19 severity

  During medical visit, up to 1 hour

• COVID-19 mortality rate

  During contact with family members, up to 1 hour

• COVID-19 impact on immunomodulatory treatment

  During medical visit, up to 1 hour

Study Arms (5)

Systemic Lupus Erythematosus

Consecutive Systemic Lupus Erythematosus patients followed-up in each service

Sjogren's Syndrome

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

Axial Spondyloarthritis

Consecutive Axial Spondyloarthritis patients followed-up in each service

Rheumatoid Arthritis

Consecutive Rheumatoid Arthritis patients followed-up in each service

Giant Cell Arteritis

Consecutive Giant Cell Arteritis patients followed-up in each service

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed-up for Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis in selected European tertiary-care centres will be contacted. The required number of patients with definite IMIDs who satisfy the inclusion criteria, followed-up in outpatient visits in the participating centres by one of the investigators, will be asked to participate. Consecutive patients fitting inclusion criteria will be selected in each centre in order to reduce bias selection.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Pitié-Salpêtrière Hospital: lead
• Università degli Studi di Ferrara: collaborator
• Rheumazentrum Ruhrgebiet: collaborator
• University College, London: collaborator
• University of Coimbra: collaborator
• Universidad Complutense de Madrid: collaborator

Study Sites (1)

Saadoun

Paris, Île-de-France Region, 75013, France

Location

Related Publications (7)

• 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.

  PMID: 32355607 BACKGROUND

• 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.

  PMID: 32335513 BACKGROUND

• 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.

  PMID: 32332072 BACKGROUND

• 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.

  PMID: 32241793 BACKGROUND

• 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.

  PMID: 32309814 BACKGROUND

• 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.

  PMID: 32226353 BACKGROUND

• 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.

  PMID: 33942031 DERIVED

MeSH Terms

Conditions

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

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; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases

Study Officials

• David Saadoun, MD, PhD

  Pitié-Salpêtrière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 21, 2020
• Study Start: June 10, 2020
• Primary Completion: December 8, 2020
• Study Completion: January 1, 2021
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

FR (1)