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Completed

NCT Number: NCT04406038

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic "Scandinavia"

Saint Petersburg, 196084, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Prevalence odds ratios

    Time frame: Measured with two-week (14 days) intervals

    Comparison of prevalence by age, sex and socioeconomic strata.

  2. Immune response dynamics

    Time frame: Measured with two-week (14 days) intervals

    Seropositivity, seroreversion and seroconversion.

Sponsors and collaborators

Lead sponsor

European University at St. Petersburg

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 28, 2020
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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