Real-world Evidence of COVID-19 Vaccines Effectiveness

Terminated

• Conditions: COVID-19 Pneumonia
• Interventions: Biological: COVID-19 Vaccines

• Registration Number: NCT04981405
• Lead Sponsor: Ivan S Moiseev

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 available

Study Timeline

• Study Start: 2021-07-16
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-29
• Status Verified: 2022-07
• Primary Completion: 2022-07-19
• Study Completion: 2022-07-19
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients referred to Medical Institute named after Berezin Sergey for computed tomography	COVID-19 Vaccines	Cases - patients with pneumonia confirmed after computed tomography. Controls - patients without pneumonia after computed tomography.
Patients hospitalised to clinics of First Pavlov State Medical University of Saint - Petersburg	COVID-19 Vaccines	450 cases - patients hospitalised with COVID-19 450 control - patients hospitalised without COVID-19 in the same period (surgical, oncological, cardiological, ophthalmologic, gastroenterological departments)

Primary Outcome Measures

Name	Time	Method
Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia	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

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

Trial Locations

Locations (2)

Mikhail Cherkashin; 🇷🇺 Saint Petersburg, Saint-Petersburg, Russian Federation

Oksana Stanevich; 🇷🇺 Saint Petersburg, Russian Federation