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Real-world Evidence of COVID-19 Vaccines Effectiveness

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04981405
Enrollment
182
Registered
2021-07-29
Start date
2021-07-16
Completion date
2022-07-19
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia

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.

Interventions

BIOLOGICALCOVID-19 Vaccines

Gam-COVID-Vac EpiVacCorona COVIVAC

Sponsors

European University at St. Petersburg
CollaboratorOTHER
Medical Institute named after Berezin Sergey
CollaboratorUNKNOWN
Ivan S Moiseev
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia3 monthsFull 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

MeasureTime frameDescription
Effectiveness of partial vaccination against hospitalization with COVID-19 pneumonia3 monthsPartial 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 groups3 monthsEvaluate vaccine effectiveness in different age groups (\<20, 20-29, 30-39, 40-49, 50-59, 60-69, \>70)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026