Subacute ThyroiditisSAT-COVID-19NCT06391515
Subacute Thyroiditis in the SARS-CoV-2 Era
An observational study of Subacute Thyroiditis and SARS CoV 2 Infection, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacute Thyroiditis, SARS CoV 2 Infection, Thyrotoxicosis
- What is being tested?
- Blood sample, CRF, thyroid ultrasound
- Type of treatment
- Vaccines
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 23 Nov 2020to 14 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- clinical diagnosis of subacute thyroiditis
- age ≥ 18 years
- willingness to sign an informed consent
Who cannot join
- ongoing pregnancy
- alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subacute Thyroiditis in the SARS-CoV-2 Era: a Multicentre Prospective Study
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.
Read the 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.
- Conditions
- Subacute Thyroiditis, SARS CoV 2 Infection, Thyrotoxicosis
- Being tested
- Blood sample, CRF, thyroid ultrasound
- Medical subject headings
- Thyroiditis, Subacute, COVID-19, Thyrotoxicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample, CRF, thyroid ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood sample, CRF, thyroid ultrasound | |
| 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. Receives: Diagnostic Test: Blood sample, CRF, thyroid ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantification of neck pain at diagnosis
evaluation in a scale from 0 to 10 (10 means maximum pain)
Measured: at diagnosis
description of neck pain at diagnosis
localization at right or left side, migrating, radiating to the ears
Measured: at diagnosis
duration of neck pain at diagnosis
duration in days
Measured: at diagnosis
Secondary outcomes (12)
quantification of neck pain at follow-up
evaluation in a scale from 0 to 10 (10 means maximum pain)
Measured: 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)
Measured: 1, 3, 6 and 12 months after diagnosis
duration of neck pain at follow-up
duration in days
Measured: 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)
Measured: 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)
Measured: 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
Measured: at diagnosis and after1, 3, 6 and 12 months
free thyroxine (fT4) at diagnosis and follow-up
free thyroxine (fT4) serum levels
Measured: at diagnosis and after1, 3, 6 and 12 months
free triiodothyronine (fT3) at diagnosis and follow-up
free triiodothyronine (fT3) serum levels
Measured: at diagnosis and after1, 3, 6 and 12 months
thyroglobulin (Tg) at diagnosis and follow-up
thyroglobulin (Tg) serum levels
Measured: at diagnosis and after1, 3, 6 and 12 months
thyroglobulin antibodies (TgAb) at diagnosis and follow-up
thyroglobulin antibodies (TgAb) serum levels
Measured: 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
Measured: at diagnosis and after1, 3, 6 and 12 months
thyrotropin receptor antibodies (TRAb) at diagnosis and follow-up
thyrotropin receptor antibodies (TRAb) serum levels
Measured: at diagnosis and after1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start23 Nov 2020
- Primary completion23 May 2022
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute ThyroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Brigante, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391515
- Sponsor's protocol ID
- 1104/2020
- Acronym
- SAT-COVID-19
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacute Thyroiditis in the SARS-CoV-2 Era: a Multicentre Prospective Study
- ClinicalTrials.gov ID
- NCT06391515
- Acronym / sponsor ID
- SAT-COVID-19 / 1104/2020
- Conditions
- Subacute Thyroiditis, SARS CoV 2 Infection, Thyrotoxicosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid + | – | Diagnostic Test: Blood sample, CRF, thyroid ultrasoundAt 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 - | – | Diagnostic Test: Blood sample, CRF, thyroid ultrasoundAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- clinical diagnosis of subacute thyroiditis
- age ≥ 18 years
- willingness to sign an informed consent
Key exclusion criteria (2 listed)
- ongoing pregnancy
- alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample, CRF, thyroid ultrasoundFive 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. | Diagnostic test | Covid +, Covid - |
Primary outcome
quantification of neck pain at diagnosis
Time frame: at diagnosis
evaluation in a scale from 0 to 10 (10 means maximum pain)
description of neck pain at diagnosis
Time frame: at diagnosis
localization at right or left side, migrating, radiating to the ears
duration of neck pain at diagnosis
Time frame: at diagnosis
duration in days
12 secondary outcomes
quantification of neck pain at follow-up
Time frame: 1, 3, 6 and 12 months after diagnosis
description of neck pain at follow-up
Time frame: 1, 3, 6 and 12 months after diagnosis
duration of neck pain at follow-up
Time frame: 1, 3, 6 and 12 months after diagnosis
thyroid inhomogeneity at ultrasound
Time frame: at diagnosis and after1, 3, 6 and 12 months
thyroid function at diagnosis and follow-up
Time frame: at diagnosis and after1, 3, 6 and 12 months
thyroid stimulating hormone (TSH) serum levels at diagnosis and follow-up
Time frame: at diagnosis and after1, 3, 6 and 12 months
free thyroxine (fT4) at diagnosis and follow-up
Time frame: at diagnosis and after1, 3, 6 and 12 months
free triiodothyronine (fT3) at diagnosis and follow-up
Time frame: at diagnosis and after1, 3, 6 and 12 months
thyroglobulin (Tg) at diagnosis and follow-up
Time frame: at diagnosis and after1, 3, 6 and 12 months
thyroglobulin antibodies (TgAb) at diagnosis and follow-up
Time frame: at diagnosis and after1, 3, 6 and 12 months
anti-thyroid peroxidase antibodies (TPOAb) at diagnosis and follow-up
Time frame: at diagnosis and after1, 3, 6 and 12 months
thyrotropin receptor antibodies (TRAb) at diagnosis and follow-up
Time frame: at diagnosis and after1, 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subacute Thyroiditis and SARS CoV 2 Infection, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantification of neck pain at diagnosis (time frame: at diagnosis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.