Subacute Thyroiditis in the SARS-CoV-2 Era
- Conditions
- Subacute ThyroiditisSARS CoV 2 InfectionThyrotoxicosis
- Registration Number
- NCT06391515
- Lead Sponsor
- University of Modena and Reggio Emilia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- clinical diagnosis of subacute thyroiditis
- age ≥ 18 years
- willingness to sign an informed consent
- ongoing pregnancy
- alcohol abuse.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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)
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)
free thyroxine (fT4) at diagnosis and follow-up at diagnosis and after1, 3, 6 and 12 months free thyroxine (fT4) serum levels
free triiodothyronine (fT3) at diagnosis and follow-up at diagnosis and after1, 3, 6 and 12 months free triiodothyronine (fT3) 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
thyroglobulin (Tg) at diagnosis and follow-up at diagnosis and after1, 3, 6 and 12 months thyroglobulin (Tg) serum levels
duration of neck pain at follow-up 1, 3, 6 and 12 months after diagnosis duration in days
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 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
thyroglobulin antibodies (TgAb) at diagnosis and follow-up at diagnosis and after1, 3, 6 and 12 months thyroglobulin antibodies (TgAb) 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
Trial Locations
- Locations (1)
University of Modena and Reggio Emilia
🇮🇹Modena, Italy
University of Modena and Reggio Emilia🇮🇹Modena, Italy