Real-world Evidence of COVID-19 Vaccines Effectiveness

NCT ID: NCT04981405

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-16

Study Completion Date

2022-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

COVID-19 Vaccines

Intervention Type BIOLOGICAL

"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.

COVID-19 Vaccines

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COVID-19 Vaccines

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European University at St. Petersburg

OTHER

Sponsor Role collaborator

Medical Institute named after Berezin Sergey

UNKNOWN

Sponsor Role collaborator

Ivan S Moiseev

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ivan S Moiseev

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mikhail Cherkashin

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Oksana Stanevich

Saint Petersburg, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36217139 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDRU-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Survey of COVID-19 Infection
NCT05706064 COMPLETED