ClinicalTrials.gg
Status unknownNCT06204393Updated May 28, 2024

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

An observational study in Graves Disease and COVID-19, sponsored by Qilu Hospital of Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Qilu Hospital of Shandong University · Observational

The sponsor has not verified this record recently (last verified Dec 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 65 Years
Sex
All
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Study 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.
Read the 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.

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Conditions studied

  • Graves Disease
  • COVID-19
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In context

Graves Disease

156 studies on the registry are indexed under Graves Disease; 54 are open to participants now.

This study's planned enrollment of 120 is close to the median of 112 across 58 observational studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 305 studies on the registry; 184 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherThyroid 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.

    Also known as: psychological evaluations, psychological interventions

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What researchers measure

Primary outcomes

  1. Serum TSH were measured with chemiluminescence method.

    TSH in µIU/mL

    Time frame: Up to 9 months

  2. Serum FT4 were measured with chemiluminescence method.

    FT4 in pmmol/L

    Time frame: Up to 9 months

  3. Serum FT3were measured with chemiluminescence method.

    FT3 in pmmol/L

    Time frame: Up to 9 months

  4. Serum TRAb were measured with chemiluminescence method.

    TRAb in IU/L

    Time frame: Up to 9 months

  5. Serum TPO-Ab were measured with chemiluminescence method.

    TPO-Ab in IU/ml

    Time frame: Up to 9 months

  6. Serum TTG-Ab were measured with chemiluminescence method.

    TG-Ab in IU/ml

    Time frame: Up to 9 months

  7. 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.

    Time frame: Up to 9 months

  8. 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.

    Time frame: Up to 9 months

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Study locations

1 of 1 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06204393
Responsible party
kuanxiao Tang (chief physician, Qilu Hospital of Shandong University) — Principal investigator
First posted
Jan 12, 2024
Start date
Jan 7, 2023
Primary completion
Aug 7, 2024 (estimated)
Completion
Aug 7, 2024 (estimated)
Last update
May 28, 2024

Study contacts

Kuanxiao Tang, M.D.
Contact
tangkx_ql@hotmail.com
18560082261
Kuanxiao Tang, M.D.
principal investigator · Qilu Hospital of Shandong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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