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TerminatedNCT04981405Updated Jul 22, 2022

Real-world Evidence of COVID-19 Vaccines Effectiveness

An observational study in COVID-19 Pneumonia, sponsored by Ivan S Moiseev. Terminated at 2 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.

Sponsored by Ivan S Moiseev · Observational

Why this study was terminated
low recruitment, end of COVID-19 pandemic
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
182
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • COVID-19 Pneumonia

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 182 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Ivan S Moiseev is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Residents of Saint-Petersburg, Russia

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
182 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BiologicalCOVID-19 Vaccines

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

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What researchers measure

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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. 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)

    Time frame: 3 months

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Study locations

2 sites
  • Mikhail Cherkashin
    Saint Petersburg, Saint-Petersburg 197022, Russian Federation
  • Oksana Stanevich
    Saint Petersburg, 197022, Russian Federation
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References and documents

Publications

  • 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. PubMed 36217139 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04981405
Lead sponsor
Ivan S Moiseev
Collaborators
European University at St. Petersburg, Medical Institute named after Berezin Sergey
Responsible party
Ivan S Moiseev (Dr, St. Petersburg State Pavlov Medical University) — Sponsor-investigator
First posted
Jul 29, 2021
Start date
Jul 16, 2021
Primary completion
Jul 19, 2022
Completion
Jul 19, 2022
Last update
Jul 22, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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