Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-29 @ 4:12 AM
Study NCT ID:
NCT05986435
Status:
UNKNOWN
Last Update Posted:
2023-08-14
First Post:
2023-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up Study of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'There are many patients who are prospectively observed. Their samples will be collected. The samples will include blood, urine, throat swabs etc.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-08', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical manifestation', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}], 'secondaryOutcomes': [{'measure': 'psychological status', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}, {'measure': 'quality of life scores', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}, {'measure': 'cranial imaging results', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}, {'measure': 'lung imaging results', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}, {'measure': 'cytokines level', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}, {'measure': 'blood biochemistry results', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}, {'measure': 'routine blood test results', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}, {'measure': 'treatment regimens', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}, {'measure': 'survival rate', 'timeFrame': '3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn the long-term prognosis of patients and the clinical characteristics of complications, which is of great significance for treatment of novel coronavirus infection pneumonia.\n\nThis trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test results. This trial does not involve the use of specific drug. Participants's health and psychological status will be observed at the preset time points. The blood, feces, urine samples of patients will be collected for relevant tests.", 'detailedDescription': "After the patients are enrolled, record the patient's treatment regimens, blood routine results, blood biochemistry results, cytokines results, lung imaging results, and cranial imaging results, understand the patient's current clinical manifestations, evaluate the patient's psychological status and quality of life, and collect samples of the patients' blood, feces, urine, and other related tests.\n\nCollection of clinical samples: collect blood, urine, throat swabs and other samples from patients with confirmed novel coronavirus pneumonia (Nucleic acid test positive), and collect samples for relevant tests at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months after discharge of patients, and record the clinical manifestations of patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The inpatients with positive SARS CoV-2 nucleic acid test results will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with confirmed COVID-19\n\nExclusion Criteria:\n\n* Combined infection with influenza virus, mycoplasma, and chlamydia.'}, 'identificationModule': {'nctId': 'NCT05986435', 'briefTitle': 'Long-term Follow-up Study of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Long-term Large Sample Multicenter Follow-up Study of COVID-19', 'orgStudyIdInfo': {'id': 'PROCOVER'}}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Ning', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '+8613971521450'}], 'facility': 'Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin You Yan', 'role': 'CONTACT', 'email': '971716425@qq.com', 'phone': '18071702539'}], 'facility': 'Wuhan Seventh Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qin Ning, Professor', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '+8613971521450'}], 'overallOfficials': [{'name': 'Qin Ning, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, department of infection', 'investigatorFullName': 'Qin Ning', 'investigatorAffiliation': 'Tongji Hospital'}}}}