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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 : Active, not recruiting
First Posted : July 29, 2021
Last Update Posted : August 4, 2021
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

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.

Condition or disease Intervention/treatment
COVID-19 Pneumonia Biological: COVID-19 Vaccines

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Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Real-world Evidence of COVID-19 Vaccine Effectiveness Against COVID-19 Hospitalization: the Case-control Study in St. Petersburg, Russia
Actual Study Start Date : July 16, 2021
Estimated Primary Completion Date : July 16, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
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)
Biological: COVID-19 Vaccines
"Gam-COVID-Vac" "EpiVacCorona" "COVIVAC"

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.
Biological: COVID-19 Vaccines
"Gam-COVID-Vac" "EpiVacCorona" "COVIVAC"




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents of Saint-Petersburg, Russia
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981405


Locations
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Russian Federation
Mikhail Cherkashin
Saint Petersburg, Saint-Petersburg, Russian Federation, 197022
Oksana Stanevich
Saint Petersburg, Russian Federation, 197022
Sponsors and Collaborators
Ivan S Moiseev
European University at St. Petersburg
Medical Institute named after Berezin Sergey
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Responsible Party: Ivan S Moiseev, Dr, St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier: NCT04981405    
Other Study ID Numbers: CDRU-003
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases