Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 3:00 PM
Study NCT ID:
NCT04544150
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Manifestations Among Patients With COVID19
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of GIT symptoms among patients with COVID-19 infection', 'timeFrame': 'Baseline', 'description': 'any GIT symptoms in such patients were recorded'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32450785', 'type': 'BACKGROUND', 'citation': 'Peck-Radosavljevic M, Danese S, Hartmann D, Saftoiu A, Van Hootegem P; UEG Public Affairs Committee. COVID-19 and digestive health. United European Gastroenterol J. 2020 Jun;8(5):624-626. doi: 10.1177/2050640620927955. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'many patients with confirmed infection with COVID-19 suffer from different symptoms and signs of gastrointestinal symptoms', 'detailedDescription': 'many patients with COVID1-9 infection experienced many intestinal symptoms mainly abdominal pain, vomiting, and diarrhea. This study aimed to assess the frequency of GIT manifestations among patients with COVID-19 and its impact on the outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients with COVID 19 infection', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients with COVID19\n\nExclusion Criteria:\n\n* patient refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT04544150', 'briefTitle': 'Gastrointestinal Manifestations Among Patients With COVID19', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Gastrointestinal Manifestations in COVID-19: Symptoms and Signs and Its Impact on the Outcome', 'orgStudyIdInfo': {'id': 'COVID19 and GUT'}}, 'armsInterventionsModule': {'interventions': [{'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Al Minyā', 'state': 'Alminya', 'country': 'Egypt', 'facility': 'Ahmed', 'geoPoint': {'lat': 29.74446, 'lon': 31.29917}}], 'overallOfficials': [{'name': 'Ahmed Abu elfatth', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit University Hospitals'}]}, 'ipdSharingStatementModule': {'url': 'https://journals.sagepub.com/doi/full/10.1177/2050640620927955', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Baseline', 'ipdSharing': 'YES', 'description': 'to public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Al-rahji University Hospital, Faculty of Medicine, Assiut, Egypt', 'investigatorFullName': 'Ahmed Mohammed Abu Elfatth', 'investigatorAffiliation': 'Assiut University'}}}}