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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04981405
Other study ID # CDRU-003
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 16, 2021
Est. completion date July 19, 2022

Study information

Verified date July 2022
Source St. Petersburg State Pavlov Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 182
Est. completion date July 19, 2022
Est. primary completion date July 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
COVID-19 Vaccines
"Gam-COVID-Vac" "EpiVacCorona" "COVIVAC"

Locations

Country Name City State
Russian Federation Mikhail Cherkashin Saint Petersburg Saint-Petersburg
Russian Federation Oksana Stanevich Saint Petersburg

Sponsors (3)

Lead Sponsor Collaborator
Ivan S Moiseev European University at St. Petersburg, Medical Institute named after Berezin Sergey

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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