Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,100
- 试验地点
- 1
- 主要终点
- COVID-19 infection
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
COVID-19 infection
时间窗: During medical visit or phone consultation, up to 2 hours
Case report form filled by the health professional
COVID-19 seroconversion
时间窗: 1 day, during routine blood collection
ELISA tests for COVID-19 antibodies
次要结局
- COVID-19 mortality rate(During contact with family members, up to 1 hour)
- Patient's fears towards COVID-19(During medical visit, up to 1 hour)
- Seroconversion rate by disease(1 day, during routine blood collection)
- Patient's beliefs in their medicines towards COVID-19(During medical visit, up to 1 hour)
- Penetration across Europe(1 day, during routine blood collection)
- COVID-19 severity(During medical visit, up to 1 hour)
- Patient-reported flares(During medical visit, up to 1 hour)
- COVID-19 impact on immunomodulatory treatment(During medical visit, up to 1 hour)
研究者
Pr David Saadoun
Principal Investigator
Pitié-Salpêtrière Hospital