COVID19 Clinical Trial
Official title:
A Population-Based Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Saint Petersburg, Russia: Longitudinal Cohort Study
NCT number | NCT04406038 |
Other study ID # | CDRU-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 27, 2020 |
Est. completion date | November 1, 2023 |
Verified date | November 2023 |
Source | European University at St. Petersburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Clinic "Scandinavia" | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
European University at St. Petersburg |
Russian Federation,
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
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 |
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