Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT06321367
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2024-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Model to Predict Coinfection in Elderly Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D060085', 'term': 'Coinfection'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coinfection', 'timeFrame': 'from admission to 7 days after admission', 'description': 'The investigators defined coinfection as coinfected bacteria, fungi, or other viruses with SARS-CoV-2 that occurred from admission to 7 days after admission. If a diagnosis was at the time of or within the first 48 hours of COVID-19 hospital admission, these infections were defined as community-acquired infections. If diagnosis occurred ≥48 hours to 7 days after admission for COVID-19, these infections were defined as early-onset hospital-acquired infections.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'elderly', 'nomogram', 'coinfections', 'diagnosis'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the clinical characteristics and construction of a predictive model in elderly COVID-19 patients. The main question it aims to answer is the main clinical characteristics and risk factors of elderly COVID-19 patients. Participants will not be asked to do any other intervening measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly COVID-19 patients admitted into Xiangya Hospital of Central South University (in Changsha, Hunan) and Xiangya Hospital of Central South University, Jiangxi (in Nanchang, Jiangxi)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 65 years old;\n* COVID-19 was diagnosed with SARS-CoV-2 reverse transcription-polymerase chain reaction positive or rapid antigen test positive or a clinical diagnosis made by the radiological responsible clinician based on signs, symptoms, or radiology consistent with COVID-19;\n* Hospitalization more than one day, including patients in emergency.\n\nExclusion Criteria:\n\n* Age less than 65 years old;\n* Pregnancy;\n* Hospitalization less than one day;\n* Outpatients;\n* Patients with missing or incomplete information.'}, 'identificationModule': {'nctId': 'NCT06321367', 'briefTitle': 'Model to Predict Coinfection in Elderly Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Construction and Validation of a Predictive Model of Coinfections in Elderly COVID-19 Patients After Abandoning Zero Policy', 'orgStudyIdInfo': {'id': '202401002'}, 'secondaryIdInfos': [{'id': '82070613', 'type': 'OTHER_GRANT', 'domain': 'the National Natural Sciences Foundation of China'}, {'id': '82370638', 'type': 'OTHER_GRANT', 'domain': 'the National Natural Sciences Foundation of China'}, {'id': '2022RC1212', 'type': 'OTHER_GRANT', 'domain': 'the Science and Technology Innovation Program of Hunan Province'}, {'id': '2023JJ10095', 'type': 'OTHER_GRANT', 'domain': 'he Natural Science Foundation of Hunan Province China'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'elderly COVID-19 patients with coinfection'}, {'label': 'elderly COVID-19 without coinfection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}