Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04981405
Status:
TERMINATED
Last Update Posted:
2022-07-22
First Post:
2021-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-world Evidence of COVID-19 Vaccines Effectiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'low recruitment, end of COVID-19 pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia', 'timeFrame': '3 months', 'description': 'Full vaccination effectiveness is calculated based on the odds ratio of vaccination proportions in cases and controls, adjusted for other patient characteristics. Full vaccination status is assigned after two weeks of the second dose for each vaccine separately.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of partial vaccination against hospitalization with COVID-19 pneumonia', 'timeFrame': '3 months', 'description': 'Partial vaccination effectiveness is calculated based on the odds ratio of vaccination proportions in cases and controls, adjusted for other patient characteristics. Partial vaccination status is assigned after two weeks of the first dose for each vaccine separately.'}, {'measure': 'Effectiveness of vaccination against hospitalization with COVID-19 pneumonia in different age groups', 'timeFrame': '3 months', 'description': 'Evaluate vaccine effectiveness in different age groups (\\<20, 20-29, 30-39, 40-49, 50-59, 60-69, \\>70)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pneumonia']}, 'referencesModule': {'references': [{'pmid': '36217139', 'type': 'DERIVED', 'citation': 'Barchuk A, Bulina A, Cherkashin M, Berezina N, Rakova T, Kuplevatskaya D, Skougarevskiy D, Okhotin A. Gam-COVID-Vac, EpiVacCorona, and CoviVac effectiveness against lung injury during Delta and Omicron variant surges in St. Petersburg, Russia: a test-negative case-control study. Respir Res. 2022 Oct 10;23(1):276. doi: 10.1186/s12931-022-02206-3.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational case-control study to evaluate COVID-19 vaccine effectiveness against hospitalisation with COVID-19 related conditions in St. Petersburg, Russia. Two sets of cases and control will be retrospectively analyzed to compare vaccination proportions and other characteristics to infer vaccine effectiveness from odds ratios. The first set of cases will be extracted from the data on hospitalisation of patients with COVID-19 to First Pavlov State Medical University of Saint-Petersburg hospitals, and controls will be patients hospitalised with other conditions. The second set of cases and controls will be based on patients referred to Medical Institute named after Berezin Sergey for computed tomography. Cases will be patients with positive SARS-CoV-2 status computed tomography confirmed pneumonia or patients referred to hospitalisation, and control will be patients without pneumonia and not referred to hospitalisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Saint-Petersburg, Russia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized to clinics of First Pavlov State Medical University of Saint-Petersburg\n* Patients referred to Medical Institute named after Berezin Sergey for computed tomography\n* Available vaccination status\n\nExclusion Criteria:\n\n\\- Refusal to provide information for research purposes at the time of hospitalization or reference to computed tomography'}, 'identificationModule': {'nctId': 'NCT04981405', 'briefTitle': 'Real-world Evidence of COVID-19 Vaccines Effectiveness', 'organization': {'class': 'OTHER', 'fullName': 'St. Petersburg State Pavlov Medical University'}, 'officialTitle': 'Real-world Evidence of COVID-19 Vaccine Effectiveness Against COVID-19 Hospitalization: the Case-control Study in St. Petersburg, Russia', 'orgStudyIdInfo': {'id': 'CDRU-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients hospitalised to clinics of First Pavlov State Medical University of Saint - Petersburg', 'description': '450 cases - patients hospitalised with COVID-19 450 control - patients hospitalised without COVID-19 in the same period (surgical, oncological, cardiological, ophthalmologic, gastroenterological departments)', 'interventionNames': ['Biological: COVID-19 Vaccines']}, {'label': 'Patients referred to Medical Institute named after Berezin Sergey for computed tomography', 'description': 'Cases - patients with pneumonia confirmed after computed tomography. Controls - patients without pneumonia after computed tomography.', 'interventionNames': ['Biological: COVID-19 Vaccines']}], 'interventions': [{'name': 'COVID-19 Vaccines', 'type': 'BIOLOGICAL', 'description': '"Gam-COVID-Vac" "EpiVacCorona" "COVIVAC"', 'armGroupLabels': ['Patients hospitalised to clinics of First Pavlov State Medical University of Saint - Petersburg', 'Patients referred to Medical Institute named after Berezin Sergey for computed tomography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '197022', 'city': 'Saint Petersburg', 'state': 'Sankt-Peterburg', 'country': 'Russia', 'facility': 'Mikhail Cherkashin', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Oksana Stanevich', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivan S Moiseev', 'class': 'OTHER'}, 'collaborators': [{'name': 'European University at St. Petersburg', 'class': 'OTHER'}, {'name': 'Medical Institute named after Berezin Sergey', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ivan S Moiseev', 'investigatorAffiliation': 'St. Petersburg State Pavlov Medical University'}}}}