Study of the Spread of COVID-19 in Saint Petersburg, Russia

November 6, 2023 updated by: European University at St. Petersburg

A Population-Based Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Saint Petersburg, Russia: Longitudinal Cohort Study

Seroprevalence study of COVID-19 in Saint Petersburg, Russia is a regional longitudinal cohort study aiming to evaluate the spread dynamics of the COVID-19 disease in the population of Saint Petersburg. Clinically asymptomatic adults are sampled from the population using random digit dialing and tested for the presence of SARS-CoV-2-specific antibodies in the blood serum. Data collection and serial sampling of the same individuals spans four weeks and is conducted every two weeks in order to understand both the spread of the virus in the population.

Study Overview

Status

Completed

Conditions

Detailed Description

At least 1 000 individuals, 18 years old and older, are randomly sampled using random digit dialing from the population of Saint Petersburg, Russia. Random sampling is performed by a survey company on the list of mobile phone numbers with designated geography prefixes of St. Petersburg. The baseline questionnaire for computer-assisted telephone interview includes travel history, medical history, and socio-economic status of the respondents. Sampled individuals are then invited to the clinic for blood sampling, their refusal to participate is recorded. Collected blood samples are used for SARS-CoV-2-specific antibodies testing. Data and sample collection spans four weeks and is conducted every two weeks. Participants complete additional questionnaires in the clinic providing information on medical history, history of allergies, chronic disease, smoking, and medication taken regularly. Contact tracing data and environmental conditions of the household are reсorded.

Study Type

Observational

Enrollment (Actual)

1038

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Representative sample of the population of Saint Petersburg, Russia

Description

Inclusion Criteria:

  • Individuals sampled from the population of Saint Petersburg, Russia using random digit dialling.
  • Subjects aged 18 and older of both genders.
  • Asymptomatic at the time of blood draw.
  • Written informed consent for a blood draw, SARS-COV-2 antibody test, and data collection.

Exclusion Criteria:

  • Presence of fever or cough or respiratory distress at the time of blood test not attributable to other known chronic disease.
  • Age under 18.
  • Any health condition that may be a contraindication towards blood sampling in out-patient clinic.
  • Residence in Kolpinskiy, Kurortniy, Krasnoselsky, Kronshtadtskiy, Petrodvorcoviy, Pushkinskiy districts of St. Petersburg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy adults
Healthy adults randomly sampled from the population of Saint Petersburg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of the SARS-COV-2 infection in Saint Petersburg, Russia
Time Frame: Measured with two-week (14 days) intervals
Measured by SARS-CoV-2-specific antibodies serial testing and corrected for volunteer bias and test characteristics.
Measured with two-week (14 days) intervals

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence odds ratios
Time Frame: Measured with two-week (14 days) intervals
Comparison of prevalence by age, sex and socioeconomic strata.
Measured with two-week (14 days) intervals
Immune response dynamics
Time Frame: Measured with two-week (14 days) intervals
Seropositivity, seroreversion and seroconversion.
Measured with two-week (14 days) intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European University at St. Petersburg

Investigators

  • Principal Investigator: Lubov Barabanova, MD, Clinic "Scandinavia"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2020

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDRU-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual phone survey data, anonymized paper-based survey data, test results, and analytic code are available in a designated repository (see the URL below).

IPD Sharing Time Frame

Currently available and for indefinite period

IPD Sharing Access Criteria

Creative Commons License Attribution 4.0 International (CC BY 4.0)

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: ID
    Information comments: Please consult with the README.md for the repository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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