Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
66 participants
OBSERVATIONAL
2020-11-23
2023-09-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis
NCT06285617
Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism
NCT04953195
Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole
NCT02727738
Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
NCT01838031
Thyroid Function Tests and Status of Thyroid Autoantibodies in Covid-19 Patients
NCT04659200
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age ≥ 18 years
* willingness to sign an informed consent
Exclusion Criteria
* alcohol abuse.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Modena and Reggio Emilia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Giulia Brigante
MD, PhD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Modena and Reggio Emilia
Modena, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1104/2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.