Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe (Euro-COVIMID)
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|ClinicalTrials.gov Identifier: NCT04397237|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2020
Last Update Posted : December 21, 2020
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.
|Condition or disease|
|COVID-19 Systemic Lupus Erythematosus Sjogren's Syndrome Axial Spondyloarthritis Rheumatoid Arthritis Giant Cell Arteritis|
|Study Type :||Observational|
|Actual Enrollment :||3100 participants|
|Official Title:||Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe|
|Actual Study Start Date :||June 10, 2020|
|Actual Primary Completion Date :||December 8, 2020|
|Estimated Study Completion Date :||January 2021|
Systemic Lupus Erythematosus
Consecutive Systemic Lupus Erythematosus patients followed-up in each service
Consecutive Sjogren's Syndrome patients followed-up in each service
Consecutive Axial Spondyloarthritis patients followed-up in each service
Consecutive Rheumatoid Arthritis patients followed-up in each service
Giant Cell Arteritis
Consecutive Giant Cell Arteritis patients followed-up in each service
- COVID-19 seroconversion [ Time Frame: 1 day, during routine blood collection ]ELISA tests for COVID-19 antibodies
- COVID-19 infection [ Time Frame: During medical visit or phone consultation, up to 2 hours ]Case report form filled by the health professional
- Seroconversion rate by disease [ Time Frame: 1 day, during routine blood collection ]Descriptive analysis for each disease's rate
- Penetration across Europe [ Time Frame: 1 day, during routine blood collection ]Descriptive analysis for each country's rate
- COVID-19 severity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During medical visit, up to 1 hour ]Case report form filled by the health professional
- Patient-reported flares [ Time Frame: During medical visit, up to 1 hour ]Case report form filled by the patient
- Patient's fears towards COVID-19 [ Time Frame: 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 [ Time Frame: During medical visit, up to 1 hour ]Beliefs about Medicines Questionnaire, going from 11 to 55, with higher scores indicating stronger beliefs regarding medicine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397237
|Paris, Ile De France, France, 75013|
|Principal Investigator:||David Saadoun, MD, PhD||Pitié-Salpêtrière Hospital|