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Active Not RecruitingNCT07213141

Incidence of Graves' Disease After COVID-19 Vaccination

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
161 (actual)
Sponsor
Laura ICONARU · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERData extractionData extraction from medical records

Timeline

Start date
2022-11-08
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2025-10-08
Last updated
2025-10-08

Locations

3 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT07213141. Inclusion in this directory is not an endorsement.