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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Graves Disease
• Intervention / Treatment: Other: Thyroid metabolic index

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Kuanxiao Tang, M.D.; Phone Number: 18560082261; Email: tangkx_ql@hotmail.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Kuanxiao Tang, M.D.; Phone Number: 18560082261; Email: tangkx_ql@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 has a course of less than 6 days; COVID-19 is mild in hyperthyroidism patients with short course of disease.	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.; Other Names: psychological evaluations; psychological interventions
COVID-19 has a course of 6-9 days; The symptoms and immune level of COVD-19 in this group are in the middle level.	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.; Other Names: psychological evaluations; psychological interventions
COVID-19 has a course of more than 9 days; Theoretically, the symptoms and immune level of COVD-19 in this group are the worst.	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.; Other Names: psychological evaluations; psychological interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum TSH were measured with chemiluminescence method.	TSH in µIU/mL	Up to 9 months
Serum FT4 were measured with chemiluminescence method.	FT4 in pmmol/L	Up to 9 months
Serum FT3were measured with chemiluminescence method.	FT3 in pmmol/L	Up to 9 months
Serum TRAb were measured with chemiluminescence method.	TRAb in IU/L	Up to 9 months
Serum TPO-Ab were measured with chemiluminescence method.	TPO-Ab in IU/ml	Up to 9 months
Serum TTG-Ab were measured with chemiluminescence method.	TG-Ab in IU/ml	Up to 9 months
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
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Kuanxiao Tang, M.D., Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2023
• Primary Completion (Estimated): August 7, 2024
• Study Completion (Estimated): August 7, 2024

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Eye Diseases; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Goiter; COVID-19; Hyperthyroidism; Graves Disease
• Other Study ID Numbers: KYLL-202307-049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No