Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT04292327
Status:
UNKNOWN
Last Update Posted:
2020-03-03
First Post:
2020-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-29', 'studyFirstSubmitDate': '2020-02-23', 'studyFirstSubmitQcDate': '2020-02-29', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28 day', 'description': 'The mortality of COVID-19 in 28 days'}, {'measure': 'The time interval of Nucleic acid detection become negative', 'timeFrame': '28 day', 'description': 'The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['2019-novel coronavirus', 'Pneumonia'], 'conditions': ['Pneumonia Caused by Human Coronavirus']}, 'descriptionModule': {'briefSummary': "Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types.\n\nMethod: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.\n\nOutcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.\n\nConclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.", 'detailedDescription': "Since December 2019, patients with unexplained pneumonia have appeared in some medical institutions in Wuhan, China. Nucleic acid testing was completed on January 10, 2020, which was confirmed to be caused by 2019-novel coronavirus. In 2020, the World Health Organization(WHO) named the virus 2019-novel coronavirus(2019-nCoV). The WHO announced that the pneumonia caused by 2019-nCoV is officially called COVID-19. Today, more than 70,000 cases have been confirmed and more than 2,000 patients have died.\n\nAt present, the epidemiological characteristics, laboratory indicators, imaging features and clinical treatment effects of COVID-19 should be reported, but the sample size is small. Large sample studies are still needed to further confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects, so as to provide a scientific basis for future clinical treatment. Therefore, it is particularly important to further review the relationship between the characteristics and prognosis of such patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria.\n\n1. 2019-nCov (SARA-Cov-2) nucleic acid positive detected by PCR.\n2. Older than 18 years old and younger than 75 years old.\n3. Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type)\n\nExclusion criteria.\n\n1. the age is less than 18 years old;\n2. pregnant or lactating women;\n3. severe underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.'}, 'identificationModule': {'nctId': 'NCT04292327', 'acronym': '2019-nCoV', 'briefTitle': 'Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Provincial Hospital'}, 'officialTitle': 'Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)', 'orgStudyIdInfo': {'id': 'KY-2020-24.01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The ordinary COVID-19', 'description': 'Consistent with the diagnosis of ordinary COVID-19.'}, {'label': 'The heavy COVID-19.', 'description': 'Consistent with the diagnosis of heavy COVID-19.'}, {'label': 'The critical COVID-19', 'description': 'Consistent with the diagnosis of critical COVID-19'}]}, 'contactsLocationsModule': {'locations': [{'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Provincial Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'overallOfficials': [{'name': 'Xiuling Shang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Provincial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate chief physician', 'investigatorFullName': 'Xiuling Shang', 'investigatorAffiliation': 'Fujian Provincial Hospital'}}}}