Real-world Evidence of COVID-19 Vaccines Effectiveness

Study Overview
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Brief Summary
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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.

Official Title
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Real-world Evidence of COVID-19 Vaccine Effectiveness Against COVID-19 Hospitalization: the Case-control Study in St. Petersburg, Russia

Conditions
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COVID-19 Pneumonia

Intervention / Treatment
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* Biological: COVID-19 Vaccines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients hospitalised to clinics of First Pavlov State Medical University of Saint - Petersburg<br>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<br>* Gam-COVID-Vac EpiVacCorona COVIVAC<br>|
| Patients referred to Medical Institute named after Berezin Sergey for computed tomography<br>Cases - patients with pneumonia confirmed after computed tomography. Controls - patients without pneumonia after computed tomography. | Biological: COVID-19 Vaccines<br>* Gam-COVID-Vac EpiVacCorona COVIVAC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of partial vaccination against hospitalization with COVID-19 pneumonia | 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. | 3 months | 
| Effectiveness of vaccination against hospitalization with COVID-19 pneumonia in different age groups | Evaluate vaccine effectiveness in different age groups (<20, 20-29, 30-39, 40-49, 50-59, 60-69, >70) | 3 months |