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

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

• Registration Number: NCT04397237
• Lead Sponsor: Pitié-Salpêtrière Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Study Start: 2020-06-10
• Status Verified: 2020-12
• Primary Completion: 2020-12-08
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-21
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COVID-19 infection	During medical visit or phone consultation, up to 2 hours	Case report form filled by the health professional
COVID-19 seroconversion	1 day, during routine blood collection	ELISA tests for COVID-19 antibodies

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Saadoun; 🇫🇷 Paris, Ile De France, France