COVID19NCT04406038
Study of the Spread of COVID-19 in Saint Petersburg, Russia
An observational study of COVID19, run by European University at St. Petersburg at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19
- How many people
- 1,038 participants
- Where
- 1 siteRussia
- Study dates
- 27 May 2020to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Representative sample of the population of Saint Petersburg, Russia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Population-Based Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Saint Petersburg, Russia: Longitudinal Cohort Study
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.
Read the 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.
- Conditions
- COVID19
- Keywords
- seroprevalence, covid-19, sars-cov-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy adults randomly sampled from the population of Saint Petersburg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured with two-week (14 days) intervals
Secondary outcomes (2)
Prevalence odds ratios
Comparison of prevalence by age, sex and socioeconomic strata.
Measured: Measured with two-week (14 days) intervals
Immune response dynamics
Seropositivity, seroreversion and seroconversion.
Measured: Measured with two-week (14 days) intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start27 May 2020
- Primary completion28 Oct 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University at St. Petersburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lubov Barabanova, MD, Principal investigator, Clinic "Scandinavia"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406038
- Sponsor's protocol ID
- CDRU-001
- Status last verified
- Nov 2023
- First submitted
- 26 May 2020
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual phone survey data, anonymized paper-based survey data, test results, and analytic code are available in a designated repository (see the URL below).
Publications
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.
PubMed 34081328Barchuk 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.
PubMed 36138385Barchuk 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.
PubMed 36123681Barchuk 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.
PubMed 36217139Barchuk 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.
PubMed 34155259Barchuk 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.
PubMed 35704649
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population-Based Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Saint Petersburg, Russia: Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT04406038
- Acronym / sponsor ID
- CDRU-001
- Conditions
- COVID19
- Keywords
- seroprevalence, covid-19, sars-cov-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,038 participants (actual)
- Lead sponsor
- European University at St. PetersburgUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | –Healthy adults randomly sampled from the population of Saint Petersburg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Representative sample of the population of Saint Petersburg, Russia
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of the SARS-COV-2 infection in Saint Petersburg, Russia
Time frame: Measured with two-week (14 days) intervals
Measured by SARS-CoV-2-specific antibodies serial testing and corrected for volunteer bias and test characteristics.
2 secondary outcomes
Prevalence odds ratios
Time frame: Measured with two-week (14 days) intervals
Immune response dynamics
Time frame: Measured with two-week (14 days) intervals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 34081328Barchuk 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.
- Background: PubMed 36138385Barchuk 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.
- Background: PubMed 36123681Barchuk 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.
- Background: PubMed 36217139Barchuk 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.
- Results publication: PubMed 34155259Barchuk 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.
- Results publication: PubMed 35704649Barchuk 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.
- Individual participant dataSharing planned: Yes. Anonymized individual phone survey data, anonymized paper-based survey data, test results, and analytic code are available in a designated repository (see the URL below).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lubov Barabanova, MD principal investigator
Clinic "Scandinavia"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19, run by European University at St. Petersburg at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the SARS-COV-2 infection in Saint Petersburg, Russia (time frame: Measured with two-week (14 days) intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406038, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.