Real-world Evidence of COVID-19 Vaccines Effectiveness

NCT04981405 | Terminated

• 1 other identifier: CDRU-003
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effectiveness of partial vaccination against hospitalization with COVID-19 pneumonia

  3 months

• Effectiveness of vaccination against hospitalization with COVID-19 pneumonia in different age groups

  3 months

Study Arms (2)

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

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

Interventions

COVID-19 Vaccines BIOLOGICAL

"Gam-COVID-Vac" "EpiVacCorona" "COVIVAC"

Patients hospitalised to clinics of First Pavlov State Medical University of Saint - Petersburg; Patients referred to Medical Institute named after Berezin Sergey for computed tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of Saint-Petersburg, Russia

You may qualify if:

• 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

You may not qualify if:

• \- Refusal to provide information for research purposes at the time of hospitalization or reference to computed tomography

Sponsors & Collaborators

• Ivan S Moiseev: lead
• European University at St. Petersburg: collaborator
• Medical Institute named after Berezin Sergey: collaborator

Study Sites (2)

Mikhail Cherkashin

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

Oksana Stanevich

Saint Petersburg, 197022, Russia

Location

Related Publications (1)

• 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.

  PMID: 36217139 DERIVED

MeSH Terms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: July 16, 2021
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

RU (2)