Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT06204393
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2023-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Investigate the Effect of 2019 Novel Coronavirus Infection on the Condition of Patients With Hyperthyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083626', 'term': 'Psychosocial Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-08-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum TSH were measured with chemiluminescence method.', 'timeFrame': 'Up to 9 months', 'description': 'TSH in µIU/mL'}, {'measure': 'Serum FT4 were measured with chemiluminescence method.', 'timeFrame': 'Up to 9 months', 'description': 'FT4 in pmmol/L'}, {'measure': 'Serum FT3were measured with chemiluminescence method.', 'timeFrame': 'Up to 9 months', 'description': 'FT3 in pmmol/L'}, {'measure': 'Serum TRAb were measured with chemiluminescence method.', 'timeFrame': 'Up to 9 months', 'description': 'TRAb in IU/L'}, {'measure': 'Serum TPO-Ab were measured with chemiluminescence method.', 'timeFrame': 'Up to 9 months', 'description': 'TPO-Ab in IU/ml'}, {'measure': 'Serum TTG-Ab were measured with chemiluminescence method.', 'timeFrame': 'Up to 9 months', 'description': 'TG-Ab in IU/ml'}, {'measure': "Assess the changes of patients' psychological state with Generalized Anxiety Disorder-7 Items Scale（GAD-7)", 'timeFrame': 'Up to 9 months', 'description': '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.'}, {'measure': "Assess the changes of patients' psychological state with Patient Health Questionnaire-9（PHQ-9）", 'timeFrame': 'Up to 9 months', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Graves Disease', 'COVID-19']}, 'descriptionModule': {'briefSummary': '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：\n\n* The main research object is Graves disease (GD) patients.\n* Changes of hyperthyroidism in GD patients complicated with COVID-19\n* Changes of anxiety and depression in GD patients before and after SARS-CoV-2 infection.\n* 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.\n2. In accordance with the diagnostic criteria of "The diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10).\n\nExclusion Criteria:\n\n1. Cases with incomplete data\n2. Patients with severe autoimmune diseases, hematological diseases and malignant tumors\n3. Immunodeficiency (e.g.AIDS, long-term use of corticosteroids or other immunosuppressive drugs leading to immunodeficiency)\n4. Follow-up was less than 30 days\n5. The results of thyroid function were less than 3 times'}, 'identificationModule': {'nctId': 'NCT06204393', 'briefTitle': 'To Investigate the Effect of 2019 Novel Coronavirus Infection on the Condition of Patients With Hyperthyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Effect of COVID-19 Infection on Thyroid Function and Psychological Status in Patients With Hyperthyroidism-one-year Intervention and Follow-up', 'orgStudyIdInfo': {'id': 'KYLL-202307-049'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 has a course of less than 6 days', 'description': 'COVID-19 is mild in hyperthyroidism patients with short course of disease.', 'interventionNames': ['Other: Thyroid metabolic index']}, {'label': 'COVID-19 has a course of 6-9 days', 'description': 'The symptoms and immune level of COVD-19 in this group are in the middle level.', 'interventionNames': ['Other: Thyroid metabolic index']}, {'label': 'COVID-19 has a course of more than 9 days', 'description': 'Theoretically, the symptoms and immune level of COVD-19 in this group are the worst.', 'interventionNames': ['Other: Thyroid metabolic index']}], 'interventions': [{'name': 'Thyroid metabolic index', 'type': 'OTHER', 'otherNames': ['psychological evaluations', 'psychological interventions'], 'description': '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.\n\nPsychological evaluations (using the 7-item Generalized Anxiety Disorder Questionnaire, GAD-7, and the Patient Health Questionnaire 9, PHQ-9) and interventions.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kuanxiao Tang, M.D.', 'role': 'CONTACT', 'email': 'tangkx_ql@hotmail.com', 'phone': '18560082261'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Kuanxiao Tang, M.D.', 'role': 'CONTACT', 'email': 'tangkx_ql@hotmail.com', 'phone': '18560082261'}], 'overallOfficials': [{'name': 'Kuanxiao Tang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'kuanxiao Tang', 'investigatorAffiliation': 'Qilu Hospital of Shandong University'}}}}