Axial Spondyloarthritis, COVID-19, Giant Cell Arteritis, Rheumatoid Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus
Conditions
Keywords
COVID-19, Systemic Lupus Erythematosus, Sjogren's Syndrome, Axial Spondyloarthritis, Rheumatoid Arthritis, Giant Cell Arteritis, Prevalence
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.
Interventions
None listed
Sponsors
Università degli Studi di Ferrara
Rheumazentrum Ruhrgebiet
University College, London
University of Coimbra
Universidad Complutense de Madrid
Pitié-Salpêtrière Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 seroconversion | 1 day, during routine blood collection | ELISA tests for COVID-19 antibodies |
| COVID-19 infection | During medical visit or phone consultation, up to 2 hours | Case report form filled by the health professional |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 severity | During medical visit, up to 1 hour | 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. |
| COVID-19 mortality rate | During contact with family members, up to 1 hour | Descriptive analysis for overall and COVID-19-linked mortality rates |
| COVID-19 impact on immunomodulatory treatment | During medical visit, up to 1 hour | Case report form filled by the health professional |
| Seroconversion rate by disease | 1 day, during routine blood collection | Descriptive analysis for each disease's rate |
| Patient's fears towards COVID-19 | During medical visit, up to 1 hour | Fear of COVID-19 scale, going from 7 to 35, where higher scores means worse outcome. |
| Patient's beliefs in their medicines towards COVID-19 | During medical visit, up to 1 hour | Beliefs about Medicines Questionnaire, going from 11 to 55, with higher scores indicating stronger beliefs regarding medicine. |
| Patient-reported flares | During medical visit, up to 1 hour | Case report form filled by the patient |
| Penetration across Europe | 1 day, during routine blood collection | Descriptive analysis for each country's rate |
Countries
France
Outcome results
None listed