Incidence of Graves' Disease After COVID-19 Vaccination

NCT07213141 | Active Not Recruiting

• 1 other identifier: CHUB-Graves
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 3

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.

Conditions

Graves Disease

Outcome Measures

Primary Outcomes (12)

• Demographic data

  Age, gender and smoking

  2 years

• COVID-19 infection (yes/no)

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

  2 years

• COVID-19 vaccination status

  Timing, type and dosing of COVID-19 vaccine administration

  2 years

• TSH levels

  Blood levels of thyroid-stimulating hormone (Thyroid hormone)

  2 years

• Free thyroxine levels

  Free thyroxine blood levels (Thyroid hormone)

  2 years

• Free T3 levels

  Free T3 blood levels (Thyroid hormone)

  2 years

• TSI levels

  Blood levels of thyroid-stimulating immunoglobulin (thyroid autoantibodies)

  2 years

• Anti-thyroperoxidase levels

  Thyroid autoantibodies levels (thyroid autoantibodies)

  2 years

• Anti-thyroglobulin levels

  Thyroid autoantibodies levels (thyroid autoantibodies)

  2 years

• Conclusions of the Thyroid ultrasound examination

  2 years

• Conclusions of the Thyroid scintigraphy examination

  2 years

• Anti-thyroid treatment

  Narrative description of anti-thyroid treatments, if any

  2 years

Study Arms (1)

'de novo' Graves' disease

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

Other: Data extraction

Interventions

Data extraction OTHER

Data extraction from medical records

'de novo' Graves' disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022. These patient cases will be identified based on the biochemical-radiological factors diagnostic for "classic" Graves' disease, i.e., hyperthyroidism in the context of positivity for TSI and/or homogeneous captation on thyroid scintigraphy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laura ICONARU: lead

Study Sites (3)

CHU St Pierre

Brussels, 1000, Belgium

Location

CHU Brugmann

Brussels, 1020, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jeroen de Filette, MD

  CHU Brugmann

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Endocrinology department

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: October 8, 2025
• Study Start: November 8, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)