Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT04481360
Status:
UNKNOWN
Last Update Posted:
2020-07-22
First Post:
2020-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical Characteristics and Outcome of COVID19 Pneumonia in Assiut University Hospital
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2020-07-11', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evaluation', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Patients assessment using CURB 65\\|(confusion ,urea level, respiratory rate blood pressure,age above 65 years) score 0 or 1 out patient -2 inpatient observation- 3 or more ICU admission.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus']}, 'descriptionModule': {'briefSummary': '* Evaluation of the clinical presentation of COVID 19 pneumonia.\n* Identification the risk factors of severing COVID 19 pneumonia.\n* Evaluation of the outcome of the disease.', 'detailedDescription': 'Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China. It was initially reported to the WHO on December 31, 2019. On January 30, 2020, the WHO declared the COVID-19 outbreak a global health emergency.On March 11, 2020, the WHO declared COVID-19 a global pandemic, its first such designation since declaring H1N1 influenza a pandemic in 2009. The incubation period for coronavirus disease 2019 (COVID-19) is believed to extend to 14 days, with a median time of 4-5 days from exposure to symptomatic onset. In one study, 97.5% of symptomatic patients developed symptoms within 11.5 days of becoming infected. Most patients with coronavirus disease 2019 (COVID-19) will experience the following (in descending frequency): Fever, Cough, Fatigue, Anorexia, Shortness of breath, Sputum production, Myalgia.\n\nAtypical presentations have been described, and older adults and persons with medical comorbidities may have delayed presentation of fever and respiratory symptoms.\n\nLess common symptoms (\\< 10%) include headache, confusion, rhinorrhea, sore throat, and hemoptysis. Some patients have experienced gastrointestinal symptoms such as diarrhoea and nausea prior to developing fever and lower respiratory tract signs and symptoms. anosmia may precede the onset of respiratory symptoms. The most common serious manifestation of COVID-19 upon the initial presentation is pneumonia. Fever, cough, dyspnea, and abnormalities on chest imaging are common in these cases. Bilateral distribution of ground-glass opacities (GGO) with or without consolidation in posterior and peripheral lungs was the cardinal hallmark of COVID-19. However, with further analysis of increasing cases, a diversity of interesting CT imaging features were found, including crazy paving pattern, airway changes, halo sign, Pleural changes including pleural thickening and pleural effusion, Vascular enlargement, Air bubble sign, Lymphadenopathy, etc, which may shed light on the possible mechanism of lung injury in COVID-19. On the laboratory aspect leukopenia, leukocytosis, and lymphopenia were common among early cases. Lactate dehydrogenase and ferritin levels are commonly elevated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200 patients diagnosed as COVID19 pneumonia and eligible for search criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with COVID 19 PCR positive\n\nExclusion Criteria:\n\n* Patients less than 18 years of age .'}, 'identificationModule': {'nctId': 'NCT04481360', 'briefTitle': 'Evaluation of Clinical Characteristics and Outcome of COVID19 Pneumonia in Assiut University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Clinical Characteristics and Outcome of COVID19 Pneumonia in Assiut', 'orgStudyIdInfo': {'id': 'Presentation of COVID19 in AUH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with covid 19 pneumonia', 'description': 'clinical presentation \\& outcome of covid 19 pneumonia', 'interventionNames': ['Device: CT of the chest']}], 'interventions': [{'name': 'CT of the chest', 'type': 'DEVICE', 'description': 'Degree of affection on the lung infected by COVID19', 'armGroupLabels': ['patients with covid 19 pneumonia']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marina Saman', 'role': 'CONTACT', 'email': 'marina011335@med.au.edu.eg', 'phone': '01204171412'}], 'overallOfficials': [{'name': 'Safaa Mokhtar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Mostafa kamal', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Marina Omil Saman', 'investigatorAffiliation': 'Assiut University'}}}}