COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 主要终点
- Incidence of adverse events (any type)
研究概览
简要总结
30 months, multicentre, prospective observational study on adult (>18 years) patients with a diagnosis of rare and complex connective tissue diseases (rCTDs) who will be given the vaccine during the period from January 2021 and January 2022.
Patients with the following diagnosis will be included:
- antiphospholipid syndrome (APS),
- Ehlers-Danlos syndrome (EDS),
- idiopathic inflammatory myopathies (IIM),
- IgG4-related disease (IgG4),
- mixed connective tissue disease (MCTD),
- relapsing polychondritis (RP),
- Sjogren's syndrome (SS),
- systemic lupus erythematosus (SLE),
- systemic sclerosis (SSc)
- undifferentiated connective tissue disease (UCTD)
详细描述
This is an observational study aimed at gathering sufficient number of cases of rCTDs patients who will receive COVID-19 vaccination that will help in better understanding of both safety and efficacy of the vaccine in this population. The study will be promoted both in ERN ReCONNET Full Members and Affiliated Partners as well as in other centres treating and managing rare and complex connective tissue diseases.
Study Objectives
- To promote a harmonised data collection approach on COVID-19 vaccination in rare and complex CTDs patients;
- To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and to highlight possible disease-specific adverse events;
- To evaluate the efficacy of COVID-19 vaccination in rCTDs patients and to highlight potential variables that prevent an effective immunization against COVID-19;
- To evaluate differences in term of efficacy and safety among different types of vaccines in rCTDs patients
- To depict the ideal patient's profile that would mostly benefit from COVID-19 vaccination
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the following diagnosis will be included:
- •antiphospholipid syndrome (APS),
- •Ehlers-Danlos syndrome (EDS),
- •idiopathic inflammatory myopathies (IIM),
- •IgG4-related disease (IgG4),
- •mixed connective tissue disease (MCTD),
- •relapsing polychondritis (RP),
- •Sjogren's syndrome (SS),
- •systemic lupus erythematosus (SLE),
- •systemic sclerosis (SSc)
- •undifferentiated connective tissue disease (UCTD)
排除标准
- •Pregnancy
- •All the exclusion criteria that apply for COVID-19 vaccination in the general population
结局指标
主要结局
Incidence of adverse events (any type)
时间窗: 12 months
COVID-19 incidence in patients with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen - cases confirmed ≥7 days after the last dose
时间窗: 12 months
次要结局
- Incidence of adverse events of special interest for COVID-19(12 months)
- Incidence of life-threatening adverse events and deaths(12 months)
- Comparison of the incidence of COVID-19 among different types of vaccines(12 months)
- Significant anti COVID 19 antibodies titer at 3 and 6 months(3 and 6 months)
- Incidence of disease flare post-vaccination(12 months)
- Incidence of serious adverse events(12 months)
- Clinical variables (age, sex, underlying disease, ongoing treatment, comorbidities) associated with COVID-19 occurrence during the post-vaccination follow-up(12 months)
研究者
Marta Mosca
Full Professor in Rheumatology
University of Pisa