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

COVID19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406038
• Other study ID #: CDRU-001
• Status: Completed
• Start date: May 27, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: European University at St. Petersburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1038
• Est. completion date: November 1, 2023
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID19

Locations

Country	Name	City	State
Russian Federation	Clinic "Scandinavia"	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
European University at St. Petersburg

Country where clinical trial is conducted

Russian Federation, 

References & Publications (6)

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. — View Citation

Barchuk A, Bulina A, Cherkashin M, Berezina N, Rakova T, Kuplevatskaya D, Stanevich O, Skougarevskiy D, Okhotin A. COVID-19 vaccines effectiveness against symptomatic SARS-CoV-2 during Delta variant surge: a preliminary assessment from a case-control study in St. Petersburg, Russia. BMC Public Health. 2022 Sep 22;22(1):1803. doi: 10.1186/s12889-022-14202-9. — View Citation

Barchuk A, Cherkashin M, Bulina A, Berezina N, Rakova T, Kuplevatskaya D, Stanevich O, Skougarevskiy D, Okhotin A. Vaccine effectiveness against referral to hospital after SARS-CoV-2 infection in St. Petersburg, Russia, during the Delta variant surge: a test-negative case-control study. BMC Med. 2022 Sep 20;20(1):312. doi: 10.1186/s12916-022-02509-8. — View Citation

Barchuk A, Shirokov D, Sergeeva M, Tursun Zade R, Dudkina O, Tychkova V, Barabanova L, Skougarevskiy D, Danilenko D. Evaluation of the performance of SARS--CoV--2 antibody assays for a longitudinal population-based study of COVID--19 spread in St. Petersburg, Russia. J Med Virol. 2021 Oct;93(10):5846-5852. doi: 10.1002/jmv.27126. Epub 2021 Jun 12. — View Citation

Barchuk A, Skougarevskiy D, Kouprianov A, Shirokov D, Dudkina O, Tursun-Zade R, Sergeeva M, Tychkova V, Komissarov A, Zheltukhina A, Lioznov D, Isaev A, Pomerantseva E, Zhikrivetskaya S, Sofronova Y, Blagodatskikh K, Titaev K, Barabanova L, Danilenko D. C — View Citation

Barchuk A, Skougarevskiy D, Titaev K, Shirokov D, Raskina Y, Novkunkskaya A, Talantov P, Isaev A, Pomerantseva E, Zhikrivetskaya S, Barabanova L, Volkov V. Seroprevalence of SARS-CoV-2 antibodies in Saint Petersburg, Russia: a population-based study. Sci — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of the SARS-COV-2 infection in Saint Petersburg, Russia	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	Prevalence odds ratios	Comparison of prevalence by age, sex and socioeconomic strata.	Measured with two-week (14 days) intervals
Secondary	Immune response dynamics	Seropositivity, seroreversion and seroconversion.	Measured with two-week (14 days) intervals