Clinical trial NCT04397237: Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe
Official title: Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Pitié-Salpêtrière Hospital
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Ferrara
name: Rheumazentrum Ruhrgebiet
name: University College, London
name: University of Coimbra
name: Universidad Complutense de Madrid
First posted: 2020-05-21
Enrollment: 3100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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;
* There are no specific inclusion criteria based on IMID previous activity, treatment or known COVID-19.

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

Primary outcomes:
measure: COVID-19 seroconversion
timeFrame: 1 day, during routine blood collection
measure: COVID-19 infection
timeFrame: During medical visit or phone consultation, up to 2 hours
Secondary outcomes:
measure: Seroconversion rate by disease
timeFrame: 1 day, during routine blood collection
measure: Penetration across Europe
timeFrame: 1 day, during routine blood collection
measure: COVID-19 severity
timeFrame: During medical visit, up to 1 hour
measure: COVID-19 mortality rate
timeFrame: During contact with family members, up to 1 hour
measure: COVID-19 impact on immunomodulatory treatment
timeFrame: During medical visit, up to 1 hour
measure: Patient-reported flares
timeFrame: During medical visit, up to 1 hour
measure: Patient's fears towards COVID-19
timeFrame: During medical visit, up to 1 hour
measure: Patient's beliefs in their medicines towards COVID-19
timeFrame: During medical visit, up to 1 hour
Other outcomes:
Locations:
city: Paris
country: France
facility: Saadoun
state: Ile De France
Study officials:
affiliation: Pitié-Salpêtrière Hospital
name: David Saadoun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.