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

Completed

• Conditions: COVID19

• Registration Number: NCT04406038
• Lead Sponsor: European University at St. Petersburg

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Study Start: 2020-05-27
• Study First Posted: 2020-05-28
• Primary Completion: 2022-10-28
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1038

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of the SARS-COV-2 infection in Saint Petersburg, Russia	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 Outcome Measures

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

Trial Locations

Locations (1)

Clinic "Scandinavia"; 🇷🇺 Saint Petersburg, Russian Federation