Incidence of Graves' Disease After COVID-19 Vaccination: a Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 161
- 试验地点
- 3
- 主要终点
- Demographic data
研究概览
简要总结
It is well known that an infection can be a triggering factor for the development of autoimmune thyroid disease. The COVID-19 pandemic was an example of this, with several reports of both subacute thyroiditis as well as Graves' disease occurring after experiencing SARS-CoV-2 disease. There have also been cases of Graves' disease reported after COVID-19 vaccination administration (<4 weeks between the vaccine and the development of hyperthyroidism). However, the current evidence is of low quality and consists mainly of case reports. A search strategy on October 3, 2022, in the medical database PubMed could only retain one retrospective study on this subject. In this study by di Filippo et al., approximately 64 new cases of Graves' disease with hyperthyroidism were identified in the Milan region, Italy, in the year 2021, of which 20 patients had an onset within 4 weeks following COVID vaccine administration (31.2%).
The investigators would like to increase the knowledge about the possible link between COVID-19 (both the disease and the vaccination) and Graves' disease, by means of a case-control analysis of all 'de novo' cases of Graves' hyperthyroidism described in the C.H.U. Brugmann. The investigators want to investigate whether Graves' disease after vaccination would be clinically different from the "classic" Graves' disease, thereby describing factors such as the duration of the disease, the level of thyroid-stimulating immunoglobulins (TSI), the percentage of T3-dominant Graves' disease, or the dose of thyreostatics (such as strumazole) required to control the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •All patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022.
排除标准
- •Pregnancy
- •Pre-existing Graves' disease (before March 2020)
- •Diagnosis of other thyroid disease, such as subacute or painless destructive thyroiditis
- •Use of thyroid-interfering drugs, such as lithium, amiodarone or immune checkpoint inhibitor therapy
结局指标
主要结局
Demographic data
时间窗: 2 years
Age, gender and smoking
COVID-19 infection (yes/no)
时间窗: 2 years
Evidence for COVID-19 infection, based on emergency room consultation, hospitalization for COVID-19, positive PCR testing or CT scan
COVID-19 vaccination status
时间窗: 2 years
Timing, type and dosing of COVID-19 vaccine administration
TSH levels
时间窗: 2 years
Blood levels of thyroid-stimulating hormone (Thyroid hormone)
Free thyroxine levels
时间窗: 2 years
Free thyroxine blood levels (Thyroid hormone)
Free T3 levels
时间窗: 2 years
Free T3 blood levels (Thyroid hormone)
TSI levels
时间窗: 2 years
Blood levels of thyroid-stimulating immunoglobulin (thyroid autoantibodies)
Anti-thyroperoxidase levels
时间窗: 2 years
Thyroid autoantibodies levels (thyroid autoantibodies)
Anti-thyroglobulin levels
时间窗: 2 years
Thyroid autoantibodies levels (thyroid autoantibodies)
Conclusions of the Thyroid ultrasound examination
时间窗: 2 years
Conclusions of the Thyroid scintigraphy examination
时间窗: 2 years
Anti-thyroid treatment
时间窗: 2 years
Narrative description of anti-thyroid treatments, if any
次要结局
未报告次要终点
研究者
Laura ICONARU
Head of Endocrinology department
Brugmann University Hospital
