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NCT Number: NCT07213141

Incidence of Graves' Disease After COVID-19 Vaccination

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Graves Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data extraction

Other

Data extraction from medical records

Primary outcomes

  1. Demographic data

    Time frame: 2 years

    Age, gender and smoking

  2. COVID-19 infection (yes/no)

    Time frame: 2 years

    Evidence for COVID-19 infection, based on emergency room consultation, hospitalization for COVID-19, positive PCR testing or CT scan

  3. COVID-19 vaccination status

    Time frame: 2 years

    Timing, type and dosing of COVID-19 vaccine administration

  4. TSH levels

    Time frame: 2 years

    Blood levels of thyroid-stimulating hormone (Thyroid hormone)

  5. Free thyroxine levels

    Time frame: 2 years

    Free thyroxine blood levels (Thyroid hormone)

  6. Free T3 levels

    Time frame: 2 years

    Free T3 blood levels (Thyroid hormone)

  7. TSI levels

    Time frame: 2 years

    Blood levels of thyroid-stimulating immunoglobulin (thyroid autoantibodies)

  8. Anti-thyroperoxidase levels

    Time frame: 2 years

    Thyroid autoantibodies levels (thyroid autoantibodies)

  9. Anti-thyroglobulin levels

    Time frame: 2 years

    Thyroid autoantibodies levels (thyroid autoantibodies)

  10. Conclusions of the Thyroid ultrasound examination

    Time frame: 2 years

  11. Conclusions of the Thyroid scintigraphy examination

    Time frame: 2 years

  12. Anti-thyroid treatment

    Time frame: 2 years

    Narrative description of anti-thyroid treatments, if any

Sponsors and collaborators

Lead sponsor

Laura ICONARU

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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