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Real-world Evidence of COVID-19 Vaccines Effectiveness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04981405
Recruitment Status : Terminated (low recruitment, end of COVID-19 pandemic)
First Posted : July 29, 2021
Last Update Posted : July 22, 2022
Sponsor:
Collaborators:
European University at St. Petersburg
Medical Institute named after Berezin Sergey
Information provided by (Responsible Party):
Ivan S Moiseev, St. Petersburg State Pavlov Medical University

Tracking Information
First Submitted Date July 26, 2021
First Posted Date July 29, 2021
Last Update Posted Date July 22, 2022
Actual Study Start Date July 16, 2021
Actual Primary Completion Date July 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 26, 2021)		 Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia [ Time Frame: 3 months ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 26, 2021)
  • Effectiveness of partial vaccination against hospitalization with COVID-19 pneumonia [ Time Frame: 3 months ]
    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.
  • Effectiveness of vaccination against hospitalization with COVID-19 pneumonia in different age groups [ Time Frame: 3 months ]
    Evaluate vaccine effectiveness in different age groups (<20, 20-29, 30-39, 40-49, 50-59, 60-69, >70)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real-world Evidence of COVID-19 Vaccines Effectiveness
Official Title Real-world Evidence of COVID-19 Vaccine Effectiveness Against COVID-19 Hospitalization: the Case-control Study in St. Petersburg, Russia
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Residents of Saint-Petersburg, Russia
Condition COVID-19 Pneumonia
Intervention Biological: COVID-19 Vaccines
"Gam-COVID-Vac" "EpiVacCorona" "COVIVAC"
Study Groups/Cohorts
  • Patients hospitalised to clinics of First Pavlov State Medical University of Saint - Petersburg
    450 cases - patients hospitalised with COVID-19 450 control - patients hospitalised without COVID-19 in the same period (surgical, oncological, cardiological, ophthalmologic, gastroenterological departments)
    Intervention: Biological: COVID-19 Vaccines
  • Patients referred to Medical Institute named after Berezin Sergey for computed tomography
    Cases - patients with pneumonia confirmed after computed tomography. Controls - patients without pneumonia after computed tomography.
    Intervention: Biological: COVID-19 Vaccines
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 19, 2022)		 182
Original Estimated Enrollment
 (submitted: July 26, 2021)		 1800
Actual Study Completion Date July 19, 2022
Actual Primary Completion Date July 19, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients hospitalized to clinics of First Pavlov State Medical University of Saint-Petersburg
  • Patients referred to Medical Institute named after Berezin Sergey for computed tomography
  • Available vaccination status

Exclusion Criteria:

- Refusal to provide information for research purposes at the time of hospitalization or reference to computed tomography
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04981405
Other Study ID Numbers CDRU-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Ivan S Moiseev, St. Petersburg State Pavlov Medical University
Original Responsible Party Same as current
Current Study Sponsor Ivan S Moiseev
Original Study Sponsor Same as current
Collaborators
  • European University at St. Petersburg
  • Medical Institute named after Berezin Sergey
Investigators Not Provided
PRS Account St. Petersburg State Pavlov Medical University
Verification Date July 2022