COVID-19 PneumoniaNCT04981405
Real-world Evidence of COVID-19 Vaccines Effectiveness
An observational study of COVID-19 Pneumonia, run by Ivan S Moiseev at 2 sites in Russia.
Trial summary
This is an observational case-control study to evaluate COVID-19 vaccine effectiveness against hospitalisation with COVID-19 related conditions in St. Petersburg, Russia. Two sets of cases and control will be retrospectively analyzed to compare vaccination proportions and other characteristics to infer vaccine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- COVID-19 Vaccines
- Type of treatment
- Vaccines
- How many people
- 182 participants
- Where
- 2 sitesRussia
- Study dates
- 16 Jul 2021to 19 Jul 2022
- 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: Residents of Saint-Petersburg, Russia
Who may be able to join
- Patients hospitalized to clinics of First Pavlov State Medical University of Saint-Petersburg
- Patients referred to Medical Institute named after Berezin Sergey for computed tomography
- Available vaccination status
Who cannot join
- Refusal to provide information for research purposes at the time of hospitalization or reference to computed tomography
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Mikhail Cherkashin
Saint Petersburg, Sankt-Peterburg, 197022
Oksana Stanevich
Saint Petersburg, 197022
About this study
Official title: Real-world Evidence of COVID-19 Vaccine Effectiveness Against COVID-19 Hospitalization: the Case-control Study in St. Petersburg, Russia
This is an observational case-control study to evaluate COVID-19 vaccine effectiveness against hospitalisation with COVID-19 related conditions in St. Petersburg, Russia. Two sets of cases and control will be retrospectively analyzed to compare vaccination proportions and other characteristics to infer vaccine effectiveness from odds ratios. The first set of cases will be extracted from the data on hospitalisation of patients with COVID-19 to First Pavlov State Medical University of Saint-Petersburg hospitals, and controls will be patients hospitalised with other conditions. The second set of cases and controls will be based on patients referred to Medical Institute named after Berezin Sergey for computed tomography. Cases will be patients with positive SARS-CoV-2 status computed tomography confirmed pneumonia or patients referred to hospitalisation, and control will be patients without pneumonia and not referred to hospitalisation.
- Conditions
- COVID-19 Pneumonia
- Being tested
- COVID-19 Vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccinesBiological
"Gam-COVID-Vac" "EpiVacCorona" "COVIVAC"
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalised to clinics of First Pavlov State Medical University of Saint - Petersburg | 450 cases - patients hospitalised with COVID-19 450 control - patients hospitalised without COVID-19 in the same period (surgical, oncological, cardiological, ophthalmologic, gastroenterological departments) Receives: Biological: COVID-19 Vaccines | |
| Patients referred to Medical Institute named after Berezin Sergey for computed tomography | Cases - patients with pneumonia confirmed after computed tomography. Controls - patients without pneumonia after computed tomography. Receives: Biological: COVID-19 Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia
Full vaccination effectiveness is calculated based on the odds ratio of vaccination proportions in cases and controls, adjusted for other patient characteristics. Full vaccination status is assigned after two weeks of the second dose for each vaccine separately.
Measured: 3 months
Secondary outcomes (2)
Effectiveness of partial vaccination against hospitalization with COVID-19 pneumonia
Partial vaccination effectiveness is calculated based on the odds ratio of vaccination proportions in cases and controls, adjusted for other patient characteristics. Partial vaccination status is assigned after two weeks of the first dose for each vaccine separately.
Measured: 3 months
Effectiveness of vaccination against hospitalization with COVID-19 pneumonia in different age groups
Evaluate vaccine effectiveness in different age groups (<20, 20-29, 30-39, 40-49, 50-59, 60-69, >70)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start16 Jul 2021
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Why it stopped: low recruitment, end of COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivan S Moiseev
- Sponsor type
- University, hospital or other
- Collaborators
- European University at St. Petersburg, Medical Institute named after Berezin Sergey
- Responsible party
- Sponsor-investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981405
- Sponsor's protocol ID
- CDRU-003
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36217139
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evidence of COVID-19 Vaccine Effectiveness Against COVID-19 Hospitalization: the Case-control Study in St. Petersburg, Russia
- ClinicalTrials.gov ID
- NCT04981405
- Acronym / sponsor ID
- CDRU-003
- Conditions
- COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low recruitment, end of COVID-19 pandemic
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Ivan S MoiseevUniversity, hospital or other
- Collaborators
- European University at St. Petersburg, Medical Institute named after Berezin Sergey
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 29 Jul 2021 (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.
This is an observational case-control study to evaluate COVID-19 vaccine effectiveness against hospitalisation with COVID-19 related conditions in St. Petersburg, Russia. Two sets of cases and control will be retrospectively analyzed to compare vaccination proportions and other characteristics to infer vaccine effectiveness from odds ratios. The first set of cases will be extracted from the data on hospitalisation of patients with COVID-19 to First Pavlov State Medical University of Saint-Petersburg hospitals, and controls will be patients hospitalised with other conditions. The second set of cases and controls will be based on patients referred to Medical Institute named after Berezin Sergey for computed tomography. Cases will be patients with positive SARS-CoV-2 status computed tomography confirmed pneumonia or patients referred to hospitalisation, and control will be patients without pneumonia and not referred to hospitalisation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalised to clinics of First Pavlov State Medical University of Saint - Petersburg | – | Biological: COVID-19 Vaccines450 cases - patients hospitalised with COVID-19 450 control - patients hospitalised without COVID-19 in the same period (surgical, oncological, cardiological, ophthalmologic, gastroenterological departments) |
| Patients referred to Medical Institute named after Berezin Sergey for computed tomography | – | Biological: COVID-19 VaccinesCases - patients with pneumonia confirmed after computed tomography. Controls - patients without pneumonia after computed tomography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Saint-Petersburg, Russia
Key inclusion criteria (3 listed)
- Patients hospitalized to clinics of First Pavlov State Medical University of Saint-Petersburg
- Patients referred to Medical Institute named after Berezin Sergey for computed tomography
- Available vaccination status
Key exclusion criteria (1 listed)
- Refusal to provide information for research purposes at the time of hospitalization or reference to computed tomography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 Vaccines"Gam-COVID-Vac" "EpiVacCorona" "COVIVAC" | Biological | Patients hospitalised to clinics of First Pavlov State Medical University of Saint - Petersburg, Patients referred to Medical Institute named after Berezin Sergey for computed tomography |
Primary outcome
Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia
Time frame: 3 months
Full vaccination effectiveness is calculated based on the odds ratio of vaccination proportions in cases and controls, adjusted for other patient characteristics. Full vaccination status is assigned after two weeks of the second dose for each vaccine separately.
2 secondary outcomes
Effectiveness of partial vaccination against hospitalization with COVID-19 pneumonia
Time frame: 3 months
Effectiveness of vaccination against hospitalization with COVID-19 pneumonia in different age groups
Time frame: 3 months
Results and safety
The study was stopped early (reason given: low recruitment, end of COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: 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.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19 Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by Ivan S Moiseev at 2 sites 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: low recruitment, end of COVID-19 pandemic). Results are not available in the source record.
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?
Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia (time frame: 3 months). 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 NCT04981405, which also lists 1 linked publication.
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 22 Jul 2022.