Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04346602
Status:
UNKNOWN
Last Update Posted:
2020-04-15
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on the Clinical and Psychological Characteristics of Patients With COVID-2019
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-12', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-12', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fever', 'timeFrame': 'one month', 'description': 'The fever is one main clinical characteristics of patients with COVID-2019, Measured by thermometer. 37.2-38 degrees Celsius, low fever; 38-39 degrees Celsius, moderate fever; 39-40 degrees Celsius, high fever.'}], 'secondaryOutcomes': [{'measure': 'cough', 'timeFrame': 'one month', 'description': 'Cough is one main symptom of patients with COVID-2019. "Yes" or "no" would be recorded.'}, {'measure': 'diarrhea', 'timeFrame': 'one month', 'description': 'Diarrhea is one symptom of some patients with COVID-2019. "Yes" or "no" would be recorded.'}, {'measure': 'anxiety', 'timeFrame': 'two months', 'description': 'Anxiety is one main psychological characteristic of patients with COVID-2019. It would be assessed by Hamilton anxiety scale (HAMA). Scores of HAMA were positively correlated with the severity of anxiety.'}, {'measure': 'insomnia', 'timeFrame': 'two months', 'description': 'Insomnia is one main psychological characteristic of patients with COVID-2019. It would be assessed by Athens insomnia scale (AIS). Scores of AIS were positively correlated with the severity of insomnia.'}, {'measure': 'depression', 'timeFrame': 'two months', 'description': 'Depression is one psychological characteristic of patients with COVID-2019.It would be assessed by Hamilton Depression Rating Scale (HAMD) . Scores of HAMD were positively correlated with the severity of depression.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-2019', 'clinical', 'psychological', 'symptom'], 'conditions': ['COVID-2019']}, 'referencesModule': {'references': [{'pmid': '33469542', 'type': 'DERIVED', 'citation': 'Yan B, Song L, Guo J, Wang Y, Peng L, Li D. Association Between Clinical Characteristics and Short-Term Outcomes in Adult Male COVID-19 Patients With Mild Clinical Symptoms: A Single-Center Observational Study. Front Med (Lausanne). 2021 Jan 5;7:571396. doi: 10.3389/fmed.2020.571396. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'A study on the clinical and psychological characteristics of patients with coronavirus disease 2019 (COVID-2019)', 'detailedDescription': 'The main objective of this study is to study the clinical and psychological responses of patients with COVID-2019 during the whole treatment process. Including clinical symptoms, auxiliary examination results, and corresponding psychological changes, including depression, anxiety, insomnia, etc. This study will draw lessons about treatment and other better advices for other countries and regions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with COVID-2019 would be observed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with COVID-2019\n\nExclusion Criteria:\n\n* No'}, 'identificationModule': {'nctId': 'NCT04346602', 'briefTitle': 'A Study on the Clinical and Psychological Characteristics of Patients With COVID-2019', 'organization': {'class': 'OTHER', 'fullName': 'Jilin University'}, 'officialTitle': 'A Study on the Clinical and Psychological Characteristics of Patients With COVID-2019', 'orgStudyIdInfo': {'id': '130004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with COVID-2019', 'description': 'Patients with COVID-2019 would be observed.', 'interventionNames': ['Other: all treatment about COVID-2019']}], 'interventions': [{'name': 'all treatment about COVID-2019', 'type': 'OTHER', 'description': 'All patients with COVID-2019 would receive treatment provided by the government and should comply with relevant laws and regulations.', 'armGroupLabels': ['patients with COVID-2019']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dong Yang, Master', 'role': 'CONTACT'}, {'name': 'Dong Yang, Master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'the First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Bai ling Yan, Doctor', 'role': 'CONTACT', 'email': 'yanbailing@163.com', 'phone': '15804300278'}, {'name': 'Dong Yang, Master', 'role': 'CONTACT', 'email': '714488468@qq.com', 'phone': '18844097668'}], 'overallOfficials': [{'name': 'Dong Yang, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Dong Yang', 'investigatorAffiliation': 'Jilin University'}}}}