Real-world Evidence of COVID-19 Vaccines Effectiveness

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04981405
• Other study ID #: CDRU-003
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia

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