Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe (Euro-COVIMID)

Pitié-Salpêtrière Hospital

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT04397237

2020-A01371-38

Details and patient eligibility

About

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.

Enrollment: 3,100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,100 participants in 5 patient groups

Systemic Lupus Erythematosus

Description:

Consecutive Systemic Lupus Erythematosus patients followed-up in each service

Sjogren's Syndrome

Description:

Consecutive Sjogren's Syndrome patients followed-up in each service

Axial Spondyloarthritis

Description:

Consecutive Axial Spondyloarthritis patients followed-up in each service

Rheumatoid Arthritis

Description:

Consecutive Rheumatoid Arthritis patients followed-up in each service

Giant Cell Arteritis

Description:

Consecutive Giant Cell Arteritis patients followed-up in each service