An observational study in Subacute Thyroiditis, SARS CoV 2 Infection and Thyrotoxicosis, sponsored by University of Modena and Reggio Emilia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by University of Modena and Reggio Emilia · Observational
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 66 is below the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →University of Modena and Reggio Emilia is the lead sponsor of 65 studies on the registry; 17 are open to participants now.
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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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Exclusion Criteria:
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.
Diagnostic Test: Blood sample, CRF, thyroid ultrasound
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.
Diagnostic Test: Blood 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.
quantification of neck pain at diagnosis
evaluation in a scale from 0 to 10 (10 means maximum pain)
Time frame: at diagnosis
description of neck pain at diagnosis
localization at right or left side, migrating, radiating to the ears
Time frame: at diagnosis
duration of neck pain at diagnosis
duration in days
Time frame: at diagnosis
quantification of neck pain at follow-up
evaluation in a scale from 0 to 10 (10 means maximum pain)
Time frame: 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)
Time frame: 1, 3, 6 and 12 months after diagnosis
duration of neck pain at follow-up
duration in days
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: at diagnosis and after1, 3, 6 and 12 months
free thyroxine (fT4) at diagnosis and follow-up
free thyroxine (fT4) serum levels
Time frame: at diagnosis and after1, 3, 6 and 12 months
free triiodothyronine (fT3) at diagnosis and follow-up
free triiodothyronine (fT3) serum levels
Time frame: at diagnosis and after1, 3, 6 and 12 months
thyroglobulin (Tg) at diagnosis and follow-up
thyroglobulin (Tg) serum levels
Time frame: at diagnosis and after1, 3, 6 and 12 months
thyroglobulin antibodies (TgAb) at diagnosis and follow-up
thyroglobulin antibodies (TgAb) serum levels
Time frame: 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
Time frame: at diagnosis and after1, 3, 6 and 12 months
thyrotropin receptor antibodies (TRAb) at diagnosis and follow-up
thyrotropin receptor antibodies (TRAb) serum levels
Time frame: at diagnosis and after1, 3, 6 and 12 months
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Ran from Nov 2020 to primary completion in May 2022, 18 months.
Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 18 months is above that.
Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Modena and Reggio Emilia