Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT05033834
Status:
UNKNOWN
Last Update Posted:
2021-09-13
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid-19 Infection in After Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'C000718127', 'term': 'COVID-19 breakthrough infections'}], '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': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-04', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-02', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the prevalence of COVID-19 infection after vaccination', 'timeFrame': 'one year', 'description': 'number of cases with covid-19 after vaccination'}], 'secondaryOutcomes': [{'measure': 'evaluate the severity of infection after vaccination', 'timeFrame': '2 weeks', 'description': 'severity of covid-19 infection in partially and fully vaccinated cases'}, {'measure': 'Predict possible risk factors of post vaccination infection', 'timeFrame': 'one year', 'description': 'adherence to protective measures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'COVID-19 vaccination', 'Post vaccination infection', 'breakthrough COVID-19', 'Partially vaccinated', 'Fully vaccinated'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in Wuhan, China. It rapidly spread, resulting a global pandemic in March 2020. Globally, till 27 August 2021, there have been 214,468,601 confirmed cases of COVID-19, including 4,470,969 deaths, reported to WHO.\n\nWith the absence of curative treatment for COVID-19 infection the development of safe and effective vaccines is critical to ending the COVID-19 pandemic. The Pfizer/BioNtech Comirnaty vaccine was listed for WHO Emergency Use Listing (EUL) on 31 December 2020. The SII/Covishield and AstraZeneca/AZD1222 vaccines (developed by AstraZeneca/Oxford and manufactured by the State Institute of India and SK Bio respectively) were given EUL on 16 February. The Janssen/Ad26.COV 2.S developed by Johnson \\& Johnson, was listed for EUL on 12 March 2021. The Moderna COVID-19 vaccine (mRNA 1273) was listed for EUL on 30 April 2021 and the Sinopharm COVID-19 vaccine was listed for EUL on 7 May 2021. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG). The Sinovac-CoronaVac was listed for EUL on 1 June 2021. As of 25 August 2021, a total of 4,953,887,422 vaccine doses have been administered. In large, randomized-controlled trials, vaccines were found to be safe and efficacious in preventing symptomatic, laboratory-confirmed COVID-19.\n\nHowever, a small percentage of fully vaccinated persons will develop symptomatic or asymptomatic infections with SARS-CoV-2, the virus that causes COVID-19. A vaccine breakthrough infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after receipt of all recommended doses of an FDA-authorized COVID-19 vaccine. A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported from 46 U.S. states and territories as of April 30, 2021. Among these cases, 6,446 (63%) occurred in females, and the median patient age was 58 years (interquartile range = 40-74 years). Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group A: people receive vaccination at the study period will be followed by phone calls or email for any new infection. Group B: patients who will be confirmed to have recent COVID-19 infection who visit outpatient clinic or admit to ward or ICU of Assiut University hospital at study period.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients 18 years old and above of both genders.\n\n * Received at least one dose of COVID-19 registered vaccines.\n * Diagnosed COVID-19 positive after vaccination by real time PCR (confirmed case) or combined clinical and radiological diagnosis (possible case).\n\nExclusion Criteria:\n\n• Children less than 18 years.\n\n* Cases non vaccinated with COVID-19 registered vaccine'}, 'identificationModule': {'nctId': 'NCT05033834', 'briefTitle': 'Covid-19 Infection in After Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Covid-19 Infection in Partially and Fully Vaccinated Cases: Cohort Study', 'orgStudyIdInfo': {'id': 'Assiut-breakthrough covid-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'People received any registered COVID-19 vaccination', 'interventionNames': ['Other: covid-19 vaccines registered in Egypt']}, {'label': 'Group B', 'description': 'People developed COVID-19 infection after partial or full vaccination with any registered COVID-19 vaccine', 'interventionNames': ['Other: covid-19 vaccines registered in Egypt']}], 'interventions': [{'name': 'covid-19 vaccines registered in Egypt', 'type': 'OTHER', 'description': 'Astra Zeneka vaccine, Sinopharm vaccine, Sinovac vaccine, Jonson and Jonson vaccine, Spotnic V vaccine', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'AssiutU', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Pulmonology Departments', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Aliae AR Mohamed-Hussein', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pulmonology', 'investigatorFullName': 'Aliae AR Mohamed Hussein', 'investigatorAffiliation': 'Assiut University'}}}}