Graves DiseaseNCT06204393
To Investigate the Effect of 2019 Novel Coronavirus Infection on the Condition of Patients With Hyperthyroidism
An observational study of Graves Disease and COVID-19, run by Qilu Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves Disease, COVID-19
- What is being tested?
- Thyroid metabolic index
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2023to 7 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Kuanxiao Tang, M.D., 18560082261, tangkx_ql@hotmail.com
About this study
Official title: 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.
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.
- Conditions
- Graves Disease, COVID-19
- Being tested
- Thyroid metabolic index
- Medical subject headings
- Graves Disease, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid metabolic indexOther
Also called psychological evaluations, psychological interventions
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 has a course of less than 6 days | COVID-19 is mild in hyperthyroidism patients with short course of disease. Receives: 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. Receives: 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. Receives: Other: Thyroid metabolic index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum TSH were measured with chemiluminescence method.
TSH in µIU/mL
Measured: Up to 9 months
Serum FT4 were measured with chemiluminescence method.
FT4 in pmmol/L
Measured: Up to 9 months
Serum FT3were measured with chemiluminescence method.
FT3 in pmmol/L
Measured: Up to 9 months
Serum TRAb were measured with chemiluminescence method.
TRAb in IU/L
Measured: Up to 9 months
Serum TPO-Ab were measured with chemiluminescence method.
TPO-Ab in IU/ml
Measured: Up to 9 months
Serum TTG-Ab were measured with chemiluminescence method.
TG-Ab in IU/ml
Measured: 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.
Measured: 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.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start7 Jan 2023
- Primary completion7 Aug 2024 (estimated)
- Study completion7 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kuanxiao Tang, Qilu Hospital of Shandong University
- Investigators
- Kuanxiao Tang, M.D., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204393
- Sponsor's protocol ID
- KYLL-202307-049
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COVID-19 Infection on Thyroid Function and Psychological Status in Patients With Hyperthyroidism-one-year Intervention and Follow-up
- ClinicalTrials.gov ID
- NCT06204393
- Acronym / sponsor ID
- KYLL-202307-049
- Conditions
- Graves Disease, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 7 Aug 2024 (estimated)
- Study completion
- 7 Aug 2024 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 has a course of less than 6 days | – | Other: Thyroid metabolic indexCOVID-19 is mild in hyperthyroidism patients with short course of disease. |
| COVID-19 has a course of 6-9 days | – | Other: Thyroid metabolic indexThe symptoms and immune level of COVD-19 in this group are in the middle level. |
| COVID-19 has a course of more than 9 days | – | Other: Thyroid metabolic indexTheoretically, the symptoms and immune level of COVD-19 in this group are the worst. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid metabolic indexAlso: psychological evaluations, psychological interventionsThe 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 | 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 |
Primary outcome
Serum TSH were measured with chemiluminescence method.
Time frame: Up to 9 months
TSH in µIU/mL
Serum FT4 were measured with chemiluminescence method.
Time frame: Up to 9 months
FT4 in pmmol/L
Serum FT3were measured with chemiluminescence method.
Time frame: Up to 9 months
FT3 in pmmol/L
Serum TRAb were measured with chemiluminescence method.
Time frame: Up to 9 months
TRAb in IU/L
Serum TPO-Ab were measured with chemiluminescence method.
Time frame: Up to 9 months
TPO-Ab in IU/ml
Serum TTG-Ab were measured with chemiluminescence method.
Time frame: Up to 9 months
TG-Ab in IU/ml
Assess the changes of patients' psychological state with Generalized Anxiety Disorder-7 Items Scale（GAD-7)
Time frame: Up to 9 months
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.
Assess the changes of patients' psychological state with Patient Health Questionnaire-9（PHQ-9）
Time frame: Up to 9 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuanxiao Tang, M.D. principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Disease and COVID-19, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuanxiao Tang, M.D. (18560082261, tangkx_ql@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum TSH were measured with chemiluminescence method. (time frame: Up to 9 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.