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

NCT04406038 | Completed

• 1 other identifier: CDRU-001
• Study Type: observational
• Target: 1,038
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19

Keywords

seroprevalence; covid-19; sars-cov-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prevalence odds ratios

  Measured with two-week (14 days) intervals

• Immune response dynamics

  Measured with two-week (14 days) intervals

Study Arms (1)

Healthy adults

Healthy adults randomly sampled from the population of Saint Petersburg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Representative sample of the population of Saint Petersburg, Russia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European University at St. Petersburg: lead

Study Sites (1)

Clinic "Scandinavia"

Saint Petersburg, 196084, Russia

Location

Related Publications (6)

• 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.

  PMID: 34081328 BACKGROUND

• 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.

  PMID: 36138385 BACKGROUND

• 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.

  PMID: 36123681 BACKGROUND

• 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.

  PMID: 36217139 BACKGROUND

• 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 Rep. 2021 Jun 21;11(1):12930. doi: 10.1038/s41598-021-92206-y.

  PMID: 34155259 RESULT

• 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. COVID-19 pandemic in Saint Petersburg, Russia: Combining population-based serological study and surveillance data. PLoS One. 2022 Jun 15;17(6):e0266945. doi: 10.1371/journal.pone.0266945. eCollection 2022.

  PMID: 35704649 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lubov Barabanova, MD

  Clinic "Scandinavia"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 28, 2020
• Study Start: May 27, 2020
• Primary Completion: October 28, 2022
• Study Completion: November 1, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Currently available and for indefinite period
• Access Criteria: Creative Commons License Attribution 4.0 International (CC BY 4.0)

Locations

RU (1)