Incidence of Graves' Disease After COVID-19 Vaccination

NCT ID: NCT07213141

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 161 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

'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

Data extraction

Intervention Type: OTHER

Data extraction from medical records

Interventions

Data extraction

Data extraction from medical records

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laura ICONARU

OTHER

Sponsor Role: lead

Responsible Party

Laura ICONARU

Head of Endocrinology department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeroen de Filette, MD

Role: STUDY_DIRECTOR

CHU Brugmann

Locations

CHU St Pierre

Brussels, , Belgium

CHU Brugmann

Brussels, , Belgium

UZ Brussel

Jette, , Belgium

Countries

Belgium

Other Identifiers

CHUB-Graves

Identifier Type: -

Identifier Source: org_study_id