Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04281693
Status:
UNKNOWN
Last Update Posted:
2020-02-24
First Post:
2020-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A New Screening Strategy for 2019 Novel Coronavirus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screening accuracy', 'timeFrame': '1 month', 'description': 'The screening accuracy of the two screening strategies were calculated and compared.'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness analysis', 'timeFrame': '1 month', 'description': 'The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Novel Coronavirus Infection Pneumonia']}, 'referencesModule': {'references': [{'pmid': '32031570', 'type': 'BACKGROUND', 'citation': 'Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.'}, {'pmid': '32064853', 'type': 'BACKGROUND', 'citation': 'Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.'}]}, 'descriptionModule': {'briefSummary': "Since Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.", 'detailedDescription': 'This clinical trial is designed to compare the screen accuracy and efficiency of two screening strategies. Considering that the general population is susceptible to 2019 nCoV, a great number of people need to be screened for NCIP. The new screening strategy of minipool testing may not only obtain a comparable accuracy to the standard individual testing, but also save time and money, which may benefit the current clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who agree to participate in the study and sign written informed consent\n\nExclusion Criteria:\n\n* Confirmed NCIP patients'}, 'identificationModule': {'nctId': 'NCT04281693', 'briefTitle': 'A New Screening Strategy for 2019 Novel Coronavirus Infection', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital to Academy of Military Medical Sciences'}, 'officialTitle': 'Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection', 'orgStudyIdInfo': {'id': '307-nCoV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening participants', 'interventionNames': ['Diagnostic Test: Standard screening strategy', 'Diagnostic Test: New screening strategy']}], 'interventions': [{'name': 'Standard screening strategy', 'type': 'DIAGNOSTIC_TEST', 'description': 'The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by individual testing.', 'armGroupLabels': ['Screening participants']}, {'name': 'New screening strategy', 'type': 'DIAGNOSTIC_TEST', 'description': 'The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by minipool testing.', 'armGroupLabels': ['Screening participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yan Liu, Ph.D.', 'role': 'CONTACT', 'email': '13911798288@163.com', 'phone': '010-66947473'}], 'facility': 'the Fifth Medical Center of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiaotian Sun', 'role': 'CONTACT', 'email': 'xiaotian-sun@hotmail.com', 'phone': '+86-01066823480'}, {'name': 'Zheng Lu', 'role': 'CONTACT', 'email': '13818223446@163.com', 'phone': '+86-01066823480'}], 'overallOfficials': [{'name': 'Yan Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing 302 Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital to Academy of Military Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing 302 Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}