To Investigate the Effect of 2019 Novel Coronavirus Infection on the Condition of Patients With Hyperthyroidism

COVID-19 Clinical Trial

Official title:

Effect of COVID-19 Infection on Thyroid Function and Psychological Status in Patients With Hyperthyroidism-one-year Intervention and Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204393
• Other study ID #: KYLL-202307-049
• Status: Recruiting
• Start date: January 7, 2023
• Est. completion date: August 7, 2024

Study information

• Verified date: December 2023
• Source: Qilu Hospital of Shandong University
• Contact: Kuanxiao Tang, M.D.
• Phone: 18560082261
• Email: tangkx_ql[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 7, 2024
• Est. primary completion date: August 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Graves Disease
• Hyperthyroidism

Intervention

Other:
• Thyroid metabolic index
The following indicators were collected from these patients: 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. Psychological evaluations (using the 7-item Generalized Anxiety Disorder Questionnaire, GAD-7, and the Patient Health Questionnaire 9, PHQ-9) and interventions.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum TSH were measured with chemiluminescence method.	TSH in µIU/mL	Up to 9 months
Primary	Serum FT4 were measured with chemiluminescence method.	FT4 in pmmol/L	Up to 9 months
Primary	Serum FT3were measured with chemiluminescence method.	FT3 in pmmol/L	Up to 9 months
Primary	Serum TRAb were measured with chemiluminescence method.	TRAb in IU/L	Up to 9 months
Primary	Serum TPO-Ab were measured with chemiluminescence method.	TPO-Ab in IU/ml	Up to 9 months
Primary	Serum TTG-Ab were measured with chemiluminescence method.	TG-Ab in IU/ml	Up to 9 months
Primary	Assess the changes of patients' psychological state with Generalized Anxiety Disorder-7 Items Scale(GAD-7)	Evaluation of anxiety state by GAD-7 scale. The lowest score of DAD-7 is 0, and the highest score is 21. The higher the score, the heavier the anxiety.	Up to 9 months
Primary	Assess the changes of patients' psychological state with Patient Health Questionnaire-9(PHQ-9)	Evaluation of depression by PHQ-9 scale. The lowest score of PHQ-9 is 0, and the highest score is 27. The higher the score, the heavier the depression.	Up to 9 months