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临床试验/NCT07213141
NCT07213141进行中(未招募)不适用

Incidence of Graves' Disease After COVID-19 Vaccination: a Retrospective Analysis

Laura ICONARU3 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2022年11月8日最近更新:
适应症

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

发起方
Laura ICONARU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Laura ICONARU

Head of Endocrinology department

Brugmann University Hospital

研究点 (3)

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