Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT06374420
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'investigating pulmonary sequelae of covid-19.', 'timeFrame': '3moth', 'description': 'The selected post covid patients on the day of their clinic visit (one to three months after being diagnosed covid 19'}, {'measure': 'investigating pulmonary sequelae of covid-19.', 'timeFrame': '6 month', 'description': 'The selected post covid patients on the day of their clinic visit (6 months after being diagnosed covid 19'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The aim of this work is to estimate the frequency of small airway disease and/or the bronchial hyperreactivity in follow up of postacute covid survivors.', 'detailedDescription': 'This is a observational longitudinal study investigating pulmonary sequelae of covid-19.\n\nStudy site:\n\nMansoura university hospital, chest department and post covid outpatient clinic.\n\nElmahalla chest hospital and outpatients clinic.\n\nTime of study :\n\nTwo years from September 2021 to September 2023\n\nTarget population:\n\nAdults with confirmed covid 19 who remaining symptomatic after 30 days from the diagnosis.\n\nSample size The study will include 100 selected cases during period from 2021 to 2023\n\nPatients :\n\nThe enrolled patients are adults who survived acute covid-19 and presented for clinical follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with confirmed covid 19 who remaining symptomatic after 30 days from the diagnosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory adult patients confirmed diagnosis of covid -19 either on typical CT chest basis or PCR and passed period of acute illness (28 days from start of symptoms) but still with clinical symptoms.\n\nExclusion Criteria:\n\n* Hospitalized or requiring intensive care unit. Known patients with chronic lung diseases Uncontrolled comorbidities'}, 'identificationModule': {'nctId': 'NCT06374420', 'briefTitle': 'Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome', 'orgStudyIdInfo': {'id': 'MD.21.11.564'}}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'Dakhlia', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tamer Awad', 'investigatorAffiliation': 'Mansoura University'}}}}