Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-30 @ 9:35 AM
Study NCT ID:
NCT05589233
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2022-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Vaccination AZV 2021-2023
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2022-10-20', 'studyFirstSubmitQcDate': '2022-10-20', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient phenotype', 'timeFrame': '1.1.2021 - 30.6.2023', 'description': 'Clinical and laboratory characteristics of patients with completed vaccination against SARS-CoV-2 admitted to the hospital in the standard ward and intensive care unit due to the severe course of COVID-19.'}], 'secondaryOutcomes': [{'measure': 'Vaccination status', 'timeFrame': '1.1.2021 - 30.6.2023', 'description': 'Defining the clinical phenotype of patients with completed vaccination against SARS-CoV-2 that is associated with the highest risk of severe course of the disease and/or death.'}, {'measure': 'Vaccine efectiveness', 'timeFrame': '1.1.2021 - 30.6.2023', 'description': 'Assessment of the difference between the effectiveness of the vaccines used in relation to the need for admission of patients to intensive care unit and indicators of clinical outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Vaccination', 'Immunity', 'Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The study is aimed at the clinical and laboratory characteristics of patients with completed vaccination against SARS-CoV-2 admitted to the hospital in the standard ward and intensive care unit due to the severe course of COVID-19.', 'detailedDescription': 'The high number of patients hospitalized for COVID-19 significantly affects the entire healthcare system, where 70-80% of the total number of patients are unvaccinated, however, approximately 20-30% of patients hospitalized for the disease COVID-19 have undergone vaccination. The investigators assume the existence of several phenotypes of infection even in vaccinated patients, which may differ both in the rate of antibody formation, the dynamics of indicators of persistent virus replication, and the intensity of a potentially self-destructive inflammatory reaction and activation of coagulation. Early identification of patients with completed vaccination who have a higher risk of a severe course of COVID or a demonstrable inadequate immune response will allow individualization of treatment. Finding out the risk characteristics of the patients is a question and the difference in the type of vaccine on the severity of the course of hospitalization and the clinical outcome of the patients can contribute to the optimization of the vaccination strategy of the population and to the early identification of risk groups of vaccinated persons from the point of view of the timely deployment of available post-exposure prophylaxis/treatment procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to the standard ward or intensive care unit with COVID-19 positive test and any number of vaccination doses against SARS-CoV-2.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* COVID-19 positiveness\n* vaccination against SARS-CoV-2 (any number of doses)\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05589233', 'briefTitle': 'COVID-19 Vaccination AZV 2021-2023', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Hradec Kralove'}, 'officialTitle': 'Clinical Phenotype of Persons Vaccinated Against Sars-CoV-2 Hospitalized for COVID-19 Disease as a Basis for Optimalization of National Vaccination Strategy and Post-exposure Prophylaxis', 'orgStudyIdInfo': {'id': 'AZVCR_FNHK_9302'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients COVID-19 positive admitted to the hospital', 'description': 'COVID-19-positive patients admitted eighter to the standard ward or intensive care unit who were vaccinated against SARS-Cov-2', 'interventionNames': ['Biological: Vaccionation eighter started or full course']}], 'interventions': [{'name': 'Vaccionation eighter started or full course', 'type': 'BIOLOGICAL', 'description': 'Vaccination against SARS-CoV-2 at any number of doses', 'armGroupLabels': ['Patients COVID-19 positive admitted to the hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Hradec Kralove', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Renata Černá Pařízková', 'investigatorAffiliation': 'University Hospital Hradec Kralove'}}}}