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Incidence of Graves' Disease After COVID-19 Vaccination

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07213141
Enrollment
161
Registered
2025-10-08
Start date
2022-11-08
Completion date
2025-12-31
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves Disease

Brief summary

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.

Interventions

Data extraction from medical records

Sponsors

Laura ICONARU
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
TSI levels2 yearsBlood levels of thyroid-stimulating immunoglobulin (thyroid autoantibodies)
Anti-thyroperoxidase levels2 yearsThyroid autoantibodies levels (thyroid autoantibodies)
Anti-thyroglobulin levels2 yearsThyroid autoantibodies levels (thyroid autoantibodies)
Conclusions of the Thyroid ultrasound examination2 years
Conclusions of the Thyroid scintigraphy examination2 years
Anti-thyroid treatment2 yearsNarrative description of anti-thyroid treatments, if any
Demographic data2 yearsAge, gender and smoking
COVID-19 infection (yes/no)2 yearsEvidence for COVID-19 infection, based on emergency room consultation, hospitalization for COVID-19, positive PCR testing or CT scan
COVID-19 vaccination status2 yearsTiming, type and dosing of COVID-19 vaccine administration
TSH levels2 yearsBlood levels of thyroid-stimulating hormone (Thyroid hormone)
Free thyroxine levels2 yearsFree thyroxine blood levels (Thyroid hormone)
Free T3 levels2 yearsFree T3 blood levels (Thyroid hormone)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026