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

NCT06204393 | Unknown

• 1 other identifier: KYLL-202307-049
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Graves Disease; COVID-19

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

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

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

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

Interventions

Thyroid metabolic index OTHER

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.

Also known as: psychological evaluations, psychological interventions

COVID-19 has a course of 6-9 days; COVID-19 has a course of less than 6 days; COVID-19 has a course of more than 9 days

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• In accordance with the diagnostic criteria of "The diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10).

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Graves Disease; COVID-19

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kuanxiao Tang, M.D.

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuanxiao Tang, M.D.

CONTACT

18560082261; tangkx_ql@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 12, 2024
• Study Start: January 7, 2023
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: May 28, 2024

Record last verified: 2023-12

Locations

CN (1)