Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-05 @ 6:35 PM
Study NCT ID:
NCT06544369
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study on COVID -19 Reinfection on Vaccinated and Non-vaccinated Outpatients
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percent of reinfection with COVID-19 in vaccinated and non vaccinated', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'scoring of symptoms in case of reinfection in vaccinated and non vaccinated', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pandemic']}, 'descriptionModule': {'briefSummary': 'the aim of the study is to compare the severity of symptoms in case of reinfection with COVID-19. the study will compare between two groups; vaccinated and non vaccinated. the side effects from vaccination and symptoms of infection and reinfection will be reprted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the study group are infected patients with COVID-19', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically diagnosed with COVID infection\n* take any type of vaccines\n\nExclusion Criteria:\n\n* no accept sharing\n* not vaccinated with COVID vaccine'}, 'identificationModule': {'nctId': 'NCT06544369', 'briefTitle': 'Prospective Study on COVID -19 Reinfection on Vaccinated and Non-vaccinated Outpatients', 'organization': {'class': 'OTHER', 'fullName': 'Deraya University'}, 'officialTitle': 'Prospective Study on COVID -19 Reinfection on Vaccinated and Non-vaccinated Outpatients', 'orgStudyIdInfo': {'id': 'Deraya university'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccinated group', 'description': 'all criteria are accepted for study', 'interventionNames': ['Biological: COVID-19 vaccin']}, {'label': 'Non-vaccinated group', 'description': 'all criteria are accepted for study', 'interventionNames': ['Biological: COVID-19 vaccin']}], 'interventions': [{'name': 'COVID-19 vaccin', 'type': 'BIOLOGICAL', 'description': 'injection', 'armGroupLabels': ['Non-vaccinated group', 'Vaccinated group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05673', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Deraya university', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soad Ali', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer of pharmaceutics and clinical pharmacy Deraya university', 'investigatorFullName': 'Soad Ali', 'investigatorAffiliation': 'Deraya University'}}}}