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

NCT ID: NCT04406038

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1038 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-27

Study Completion Date

2023-11-01

Brief Summary

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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

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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.

Conditions

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COVID19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy adults

Healthy adults randomly sampled from the population of Saint Petersburg

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European University at St. Petersburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lubov Barabanova, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic "Scandinavia"

Locations

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Clinic "Scandinavia"

Saint Petersburg, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type BACKGROUND
PMID: 34081328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36138385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36123681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36217139 (View on PubMed)

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.

Reference Type RESULT
PMID: 34155259 (View on PubMed)

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.

Reference Type RESULT
PMID: 35704649 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Study Documents

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Document Type: Individual Participant Data Set

Please consult with the README.md for the repository.

View Document

Other Identifiers

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CDRU-001

Identifier Type: -

Identifier Source: org_study_id

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