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

Study Overview
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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.

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

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

Participation Criteria
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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; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systemic Lupus Erythematosus<br>Consecutive Systemic Lupus Erythematosus patients followed-up in each service | |
| Sjogren's Syndrome<br>Consecutive Sjogren's Syndrome patients followed-up in each service | |
| Axial Spondyloarthritis<br>Consecutive Axial Spondyloarthritis patients followed-up in each service | |
| Rheumatoid Arthritis<br>Consecutive Rheumatoid Arthritis patients followed-up in each service | |
| Giant Cell Arteritis<br>Consecutive Giant Cell Arteritis patients followed-up in each service | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate by disease | Descriptive analysis for each disease's rate | 1 day, during routine blood collection | 
| Penetration across Europe | Descriptive analysis for each country's rate | 1 day, during routine blood collection | 
| 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 | 
| COVID-19 mortality rate | Descriptive analysis for overall and COVID-19-linked mortality rates | During contact with family members, up to 1 hour | 
| COVID-19 impact on immunomodulatory treatment | Case report form filled by the health professional | During medical visit, up to 1 hour | 
| Patient-reported flares | Case report form filled by the patient | During medical visit, up to 1 hour | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Systemic Lupus Erythematosus, Sjogren's Syndrome, Axial Spondyloarthritis, Rheumatoid Arthritis, Giant Cell Arteritis, Prevalence