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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covid + | At baseline, a blood sample was collected and centrifuged for serological analysis. Then, sera were stored at -20°C until the end of the enrolment phase when all samples were centralized at the coordinating center for SARS-CoV-2 IgG measurements. IgG against the spike protein (anti-S IgG) and against nucleocapside (anti-N IgG) were tested. Anti-N IgG increase only after natural infection since the nucleocapsid protein is not contained in the vaccines, while anti-S IgG increase is induced either by vaccination or infection 21. Thus, we subdivided patients according to their serological status: i) group Covid+ included those patients who had both positive anti-S and anti-N IgG demonstrating a contact with SARS-CoV-2 before the diagnosis of SAT; ii) group Covid- consisted of patients with only anti-S IgG positivity (due to vaccine) or negative anti-N/anti-S IgG. |
| |
| Covid - | At baseline, a blood sample was collected and centrifuged for serological analysis. Then, sera were stored at -20°C until the end of the enrolment phase when all samples were centralized at the coordinating center for SARS-CoV-2 IgG measurements. IgG against the spike protein (anti-S IgG) and against nucleocapside (anti-N IgG) were tested. Anti-N IgG increase only after natural infection since the nucleocapsid protein is not contained in the vaccines, while anti-S IgG increase is induced either by vaccination or infection 21. Thus, we subdivided patients according to their serological status: i) group Covid+ included those patients who had both positive anti-S and anti-N IgG demonstrating a contact with SARS-CoV-2 before the diagnosis of SAT; ii) group Covid- consisted of patients with only anti-S IgG positivity (due to vaccine) or negative anti-N/anti-S IgG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample, CRF, thyroid ultrasound | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| quantification of neck pain at diagnosis | evaluation in a scale from 0 to 10 (10 means maximum pain) | at diagnosis |
| description of neck pain at diagnosis | localization at right or left side, migrating, radiating to the ears | at diagnosis |
| duration of neck pain at diagnosis | duration in days | at diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| quantification of neck pain at follow-up | evaluation in a scale from 0 to 10 (10 means maximum pain) | 1, 3, 6 and 12 months after diagnosis |
| description of neck pain at follow-up | localization at right or left side, migrating, radiating to the earsmaximum pain) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with clinical diagnosis of SAT were enrolled. Diagnosis was made by experienced endocrinologists according to guidelines 2: thyroid tenderness and anterior neck pain, often radiating to ears, jaw, or throat, spreading from one side to the other, low-grade fever, pharyngitis symptoms, fatigue, thyroid slightly enlarged, firm and painful to palpation, ESR or CRP elevation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Modena and Reggio Emilia | Modena | 41125 | Italy |
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| ID | Term |
|---|---|
| D013968 | Thyroiditis, Subacute |
| D000086382 | COVID-19 |
| D013971 | Thyrotoxicosis |
| ID | Term |
|---|---|
| D013966 | Thyroiditis |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 1, 3, 6 and 12 months after diagnosis |
| duration of neck pain at follow-up | duration in days | 1, 3, 6 and 12 months after diagnosis |
| thyroid inhomogeneity at ultrasound | 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) | at diagnosis and after1, 3, 6 and 12 months |
| thyroid function at diagnosis and follow-up | thyroid stimulating hormone (TSH), free thyroxine (fT4), free triiodothyronine (fT3), thyroglobulin (Tg), thyroglobulin antibodies (TgAb), anti-thyroid peroxidase antibodies (TPOAb), thyrotropin receptor antibodies (TRAb) | at diagnosis and after1, 3, 6 and 12 months |
| thyroid stimulating hormone (TSH) serum levels at diagnosis and follow-up | thyroid stimulating hormone (TSH) serum levels | at diagnosis and after1, 3, 6 and 12 months |
| free thyroxine (fT4) at diagnosis and follow-up | free thyroxine (fT4) serum levels | at diagnosis and after1, 3, 6 and 12 months |
| free triiodothyronine (fT3) at diagnosis and follow-up | free triiodothyronine (fT3) serum levels | at diagnosis and after1, 3, 6 and 12 months |
| thyroglobulin (Tg) at diagnosis and follow-up | thyroglobulin (Tg) serum levels | at diagnosis and after1, 3, 6 and 12 months |
| thyroglobulin antibodies (TgAb) at diagnosis and follow-up | thyroglobulin antibodies (TgAb) serum levels | at diagnosis and after1, 3, 6 and 12 months |
| anti-thyroid peroxidase antibodies (TPOAb) at diagnosis and follow-up | anti-thyroid peroxidase antibodies (TPOAb) serum levels | at diagnosis and after1, 3, 6 and 12 months |
| thyrotropin receptor antibodies (TRAb) at diagnosis and follow-up | thyrotropin receptor antibodies (TRAb) serum levels | at diagnosis and after1, 3, 6 and 12 months |
| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006980 | Hyperthyroidism |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |