Clinical trial NCT06204393: To Investigate the Effect of 2019 Novel Coronavirus Infection on the Condition of Patients With Hyperthyroidism
Official title: Effect of COVID-19 Infection on Thyroid Function and Psychological Status in Patients With Hyperthyroidism-one-year Intervention and Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Graves Disease
COVID-19
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cases came from HT patients who were followed up in the outpatient department of general medicine of Qilu Hospital of Shandong University, and a total of 120 hyperthyroidism patients were enrolled, who are in the maintenance stage of HT treatment and have a history of COVID-19 in the past 3 months.

Brief summary: The goal of this observational study is to learn about the correlation between COVID-19 and hyperthyroidism in Patients with hyperthyroidism complicated with COVID-19. The main questions it aims to answer are：

* The main research object is Graves disease (GD) patients.
* Changes of hyperthyroidism in GD patients complicated with COVID-19
* Changes of anxiety and depression in GD patients before and after SARS-CoV-2 infection.
* The effect of psychological intervention in GD patients after COVID-19. Participants will have regular follow-upfor one year to hyperthyroidism in our hospital, and the investigators will collect the thyroid function and related examination indexes of patients in the corresponding time period.

Detailed description: Longitudinal analysis of GD status was performed: Three follow-up time points were identified: before COVID-19, three months and one year after recovering from COVID-19 (the first follow-up visit, the second follow-up visit. Main collection items: Hyperthyroidism symptoms, signs, hyperthyroidism complications, psychological evaluation results, other complications，blood routine, liver and kidney function, thyroid function (FT3, FT4, TSH), thyroid-related antibodies, glucose and lipid metabolism (FBG, HbA1c, TC, TG, HDL-C, LDL-C), thyroid ultrasound and hyperthyroidism medication.Through this to understand the changes of hyperthyroidism in HT patients complicated with COVID-19 and the changes of anxiety and depression in hyperthyroidism patients before and after SARS-CoV-2 infection.And the effect of psychological intervention in GD patients after COVID-19.

Eligibility criteria: Inclusion Criteria:

1. According to the diagnostic criteria of hyperthyroidism in the Chinese Guidelines for the Diagnosis and Treatment of Thyroid Diseases formulated by the Chinese Society of Endocrinology of the Chinese Medical Association, the patient had been diagnosed with hyperthyroidism.
2. In accordance with the diagnostic criteria of "The diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10).

Exclusion Criteria:

1. Cases with incomplete data
2. Patients with severe autoimmune diseases, hematological diseases and malignant tumors
3. Immunodeficiency (e.g.AIDS, long-term use of corticosteroids or other immunosuppressive drugs leading to immunodeficiency)
4. Follow-up was less than 30 days
5. The results of thyroid function were less than 3 times

Primary outcomes:
measure: Serum TSH were measured with chemiluminescence method.
timeFrame: Up to 9 months
measure: Serum FT4 were measured with chemiluminescence method.
timeFrame: Up to 9 months
measure: Serum FT3were measured with chemiluminescence method.
timeFrame: Up to 9 months
measure: Serum TRAb were measured with chemiluminescence method.
timeFrame: Up to 9 months
measure: Serum TPO-Ab were measured with chemiluminescence method.
timeFrame: Up to 9 months
measure: Serum TTG-Ab were measured with chemiluminescence method.
timeFrame: Up to 9 months
measure: Assess the changes of patients' psychological state with Generalized Anxiety Disorder-7 Items Scale（GAD-7)
timeFrame: Up to 9 months
measure: Assess the changes of patients' psychological state with Patient Health Questionnaire-9（PHQ-9）
timeFrame: Up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Kuanxiao Tang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: