SARS CoV 2 Infection, Subacute Thyroiditis, Thyrotoxicosis
Conditions
Brief summary
Many cases of subacute thyroiditis (SAT) have been described related to SARS-CoV-2 infection, but no prospective data about follow-up is known. This prospective, longitudinal, 3-year, multicentre study is aimed at exploring clinical peculiarities and outcome of SAT in relation to SARS-CoV-2 infection, ascertained with antibody dosage. All patients receiving SAT diagnosis from November 2020 to May 2022 were enrolled. Multicentre study. Data about anamnesis, physical examination, blood tests (TSH, freeT4, freeT3, thyroglobulin, anti-thyroid antibodies, C-reactive protein, erythrocyte sedimentation rate, complete blood count), and thyroid ultrasound were collected. At baseline, the presence of IgG against the SARS-CoV-2 spike protein or nucleocapside was investigated. Patients were evaluated after 1, 3, 6, 12 months.
Detailed description
A multicentre, longitudinal, prospective study was conducted, enrolling all patients diagnosed with SAT at the participating centres between November 2020 and May 2022. The following Italian centres participated: Endocrinology Unit of Azienda Ospedaliero-Universitaria of Modena (Coordinating center); Endocrinology Unit of IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano; Endocrinology and Diabetes Prevention and Care Unit of the IRCCS Azienda Ospedaliero-Universitaria Policlinico of Bologna. These Units were involved through a call launched by the coordinating center to the young Italian members of the Club EnGioI (Endocrinologia Giovane in Italia) of the Italian Society of Endocrinology (SIE). Five visits were planned: at diagnosis (V0) and after 1, 3, 6 and 12 months (V1, V2, V3 and V4, respectively). At each visit, subjects were evaluated with anamnesis, physical examination, thyroid ultrasound and blood tests. Patients were treated according to the clinical presentation and to the current guidelines. Nonsteroidal anti-inflammatory drugs (NSAIDs) were preferred in patients with mild symptoms and mild laboratory findings; steroid therapy was preferred in those with severe symptoms and/or those who did not respond to NSAIDs within 1 to 2 weeks. Beta-blockers were prescribed as symptomatic treatment in case of tachycardia. During the follow-up phase, the therapeutic approach and any change of it were recorded. Finally, the treatment responsiveness and outcomes of transient hypothyroidism, permanent hypothyroidism, or recurrence during the follow-up period were all documented.
Interventions
DIAGNOSTIC_TESTBlood sample, CRF, thyroid ultrasound
Five visits were planned: at diagnosis (V0) and after 1, 3, 6 and 12 months (V1, V2, V3 and V4, respectively). At each visit, subjects were evaluated with anamnesis, physical examination, thyroid US and blood tests.
Sponsors
University of Modena and Reggio Emilia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of subacute thyroiditis * age ≥ 18 years * willingness to sign an informed consent
Exclusion criteria
* ongoing pregnancy * alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quantification of neck pain at diagnosis | at diagnosis | evaluation in a scale from 0 to 10 (10 means maximum pain) |
| description of neck pain at diagnosis | at diagnosis | localization at right or left side, migrating, radiating to the ears |
| duration of neck pain at diagnosis | at diagnosis | duration in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| thyroid inhomogeneity at ultrasound | at diagnosis and after1, 3, 6 and 12 months | US examination performed by endocrinologists with at least 5 years of experience in US neck examination with a linear probe. SAT-related findings such as inhomogeneity will be evaluated (present or absent) |
| thyroid function at diagnosis and follow-up | at diagnosis and after1, 3, 6 and 12 months | thyroid stimulating hormone (TSH), free thyroxine (fT4), free triiodothyronine (fT3), thyroglobulin (Tg), thyroglobulin antibodies (TgAb), anti-thyroid peroxidase antibodies (TPOAb), thyrotropin receptor antibodies (TRAb) |
| thyroid stimulating hormone (TSH) serum levels at diagnosis and follow-up | at diagnosis and after1, 3, 6 and 12 months | thyroid stimulating hormone (TSH) serum levels |
| free thyroxine (fT4) at diagnosis and follow-up | at diagnosis and after1, 3, 6 and 12 months | free thyroxine (fT4) serum levels |
| quantification of neck pain at follow-up | 1, 3, 6 and 12 months after diagnosis | evaluation in a scale from 0 to 10 (10 means maximum pain) |
| thyroglobulin (Tg) at diagnosis and follow-up | at diagnosis and after1, 3, 6 and 12 months | thyroglobulin (Tg) serum levels |
| thyroglobulin antibodies (TgAb) at diagnosis and follow-up | at diagnosis and after1, 3, 6 and 12 months | thyroglobulin antibodies (TgAb) serum levels |
| anti-thyroid peroxidase antibodies (TPOAb) at diagnosis and follow-up | at diagnosis and after1, 3, 6 and 12 months | anti-thyroid peroxidase antibodies (TPOAb) serum levels |
| thyrotropin receptor antibodies (TRAb) at diagnosis and follow-up | at diagnosis and after1, 3, 6 and 12 months | thyrotropin receptor antibodies (TRAb) serum levels |
| free triiodothyronine (fT3) at diagnosis and follow-up | at diagnosis and after1, 3, 6 and 12 months | free triiodothyronine (fT3) serum levels |
| description of neck pain at follow-up | 1, 3, 6 and 12 months after diagnosis | localization at right or left side, migrating, radiating to the earsmaximum pain) |
| duration of neck pain at follow-up | 1, 3, 6 and 12 months after diagnosis | duration in days |
Countries
Italy
Outcome results
None listed