Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-28 @ 2:18 PM
Study NCT ID:
NCT04279795
Status:
UNKNOWN
Last Update Posted:
2020-02-21
First Post:
2020-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive rate of 2019 Novel Coronavirus RNA', 'timeFrame': '28 days', 'description': 'rate of positive results of detection 2019 Novel Coronavirus nucleic acid from urine, blood, anal swabs and pharyngeal swabs samples'}], 'secondaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '28 days', 'description': 'If the patient will survive after comprehensive treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['2019 Novel Coronavirus'], 'conditions': ['Coronavirus']}, 'descriptionModule': {'briefSummary': 'Outbreak of 2019 Novel Coronavirus infection quickly spread to the world. Confirmed patients were isolated and treated in our department. 2019 Novel Coronavirus was detected in multiple organ system. Clinical data was recorded to investigate the its relationship with viral detection.', 'detailedDescription': "Medical date of suspected patients of 2019 Novel Coronavirus infection, who came to outpatient department of the Third Affiliated Hospital of Sun Yat-sen University, were sent to an expert group if they met the inclusion criteria. The expert group discussed and made a decision if the patient would be admission to isolation unit. Pharyngeal swabs of the patients were obtained and sent to local Center for Disease Control and Prevention (CDC) for detection the 2019 Novel Coronavirus after patients were admission to isolation unit. Diagnosis of 2019 Novel Coronavirus infection was confirmed if the result was positive or excluded if two consecutive results were negative. Patients' demographic data and clinical characteristics were recorded. Clinical characteristics including epidemiological history, past history, personal history, symptoms, signs, blood cells count, biochemical test results, chest computed tomography (CT) images. 2019 Novel Coronavirus RNA was detected in pharyngeal swab, anal swab, urine and blood samples by using quantitative real-time polymerase chain reaction (qPCR). Comprehensive treatments were given to the patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Confirmed patients of 2019 Novel Coronavirus infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Epidemiological history including resident of Hubei province, or travel history to Hubei province or exposure to suspected patients in the past two weeks.\n2. Symptoms like fever, fatigue, myalgia, headache, cough, sputum production, chest tightness, dyspnea, etc.\n3. White blood cells decreased or were normal, or lymphocytes decreased, and chest CT images showed typical findings of viral pneumonia.\n4. Detection of 2019 Novel Coronavirus nucleic acid is positive by local Center for Disease Control and Prevention (CDC).\n\nExclusion Criteria:\n\n1. Patients can not follow-up;\n2. Investigator considering inappropriate.'}, 'identificationModule': {'nctId': 'NCT04279795', 'briefTitle': 'Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations', 'organization': {'class': 'OTHER', 'fullName': 'Third Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Study on Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations in Patients', 'orgStudyIdInfo': {'id': 'PL11'}}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Peng, Doctor', 'role': 'CONTACT', 'email': 'pzp33@hotmail.com', 'phone': '+8613533978874'}], 'facility': 'The Third Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Wenxiong Xu, Doctor', 'role': 'CONTACT', 'email': 'xwx1983@163.com', 'phone': '+8613760783281'}, {'name': 'Liang Peng, Doctor', 'role': 'CONTACT', 'email': 'pzp33@hotmail.com', 'phone': '+8613533978874'}], 'overallOfficials': [{'name': 'Liang Peng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professer', 'investigatorFullName': 'Liang Peng', 'investigatorAffiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}}}}