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

COVID-19 Clinical Trial

— Euro-COVIMID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04397237
• Other study ID #: 2020-A01371-38
• Status: Active, not recruiting
• Start date: June 10, 2020
• Est. completion date: January 2021

Study information

• Verified date: December 2020
• Source: Pitié-Salpêtrière Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3100
• Est. completion date: January 2021
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases
• Axial Spondyloarthritis
• COVID-19
• Giant Cell Arteritis
• Lupus Erythematosus, Systemic
• Polymyalgia Rheumatica
• Rheumatoid Arthritis
• Sjogren's Syndrome
• Spondylarthritis
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
France	Saadoun	Paris	Ile De France

Sponsors (6)

Lead Sponsor	Collaborator
Pitié-Salpêtrière Hospital	Rheumazentrum Ruhrgebiet, Universidad Complutense de Madrid, Università degli Studi di Ferrara, University College, London, University of Coimbra

Country where clinical trial is conducted

France, 

References & Publications (6)

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. 2020 Mar 27:1-9. doi: 10.1007/s11469-020-00270-8. [Epub ahead of print] — View 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. — View 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. — View 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, Hié M, Juillard L, Lhote R, Maillet T, Richard-Colmant G, Palluy JB, Pha M, Perard L, Remy P, Rivière E, Sène D, Sève P, Morélot-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. — View 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. — View Citation

Pope JE. What Does the COVID-19 Pandemic Mean for Rheumatology Patients? Curr Treatm Opt Rheumatol. 2020 Apr 30:1-4. doi: 10.1007/s40674-020-00145-y. [Epub ahead of print] Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 seroconversion	ELISA tests for COVID-19 antibodies	1 day, during routine blood collection
Primary	COVID-19 infection	Case report form filled by the health professional	During medical visit or phone consultation, up to 2 hours
Secondary	Seroconversion rate by disease	Descriptive analysis for each disease's rate	1 day, during routine blood collection
Secondary	Penetration across Europe	Descriptive analysis for each country's rate	1 day, during routine blood collection
Secondary	COVID-19 severity	World Health Organization ordinal scale for clinical improvement at any given point of the infection, going from 0 to 8, where higher scores means worse outcome.	During medical visit, up to 1 hour
Secondary	COVID-19 mortality rate	Descriptive analysis for overall and COVID-19-linked mortality rates	During contact with family members, up to 1 hour
Secondary	COVID-19 impact on immunomodulatory treatment	Case report form filled by the health professional	During medical visit, up to 1 hour
Secondary	Patient-reported flares	Case report form filled by the patient	During medical visit, up to 1 hour
Secondary	Patient's fears towards COVID-19	Fear of COVID-19 scale, going from 7 to 35, where higher scores means worse outcome.	During medical visit, up to 1 hour
Secondary	Patient's beliefs in their medicines towards COVID-19	Beliefs about Medicines Questionnaire, going from 11 to 55, with higher scores indicating stronger beliefs regarding medicine.	During medical visit, up to 1 hour

External Links

•   Beliefs about Medicines Questionnaire
•   World Health Organization Ordinal Scale for Clinical Improvement