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.
Study Type
OBSERVATIONAL
Enrollment
3,100
Saadoun
Paris, Île-de-France Region, France
COVID-19 seroconversion
ELISA tests for COVID-19 antibodies
Time frame: 1 day, during routine blood collection
COVID-19 infection
Case report form filled by the health professional
Time frame: During medical visit or phone consultation, up to 2 hours
Seroconversion rate by disease
Descriptive analysis for each disease's rate
Time frame: 1 day, during routine blood collection
Penetration across Europe
Descriptive analysis for each country's rate
Time frame: 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.
Time frame: During medical visit, up to 1 hour
COVID-19 mortality rate
Descriptive analysis for overall and COVID-19-linked mortality rates
Time frame: During contact with family members, up to 1 hour
COVID-19 impact on immunomodulatory treatment
Case report form filled by the health professional
Time frame: During medical visit, up to 1 hour
Patient-reported flares
Case report form filled by the patient
Time frame: 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.
Time frame: 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.
Time frame: During medical visit, up to 1 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.