SeroprevalenceNCT05124535
Population-based Age-stratified Seroepidemiological Investigation Protocol for Coronavirus 2019 (COVID-19) Infection in the Federation of Bosnia and Herzegovina
An observational study of Seroprevalence and Antibody, run by Institute for Public Health of the Federation of Bosnia and Herzegovina at 1 site in Bosnia and Herzegovina.
Trial summary
This study is the second cross-sectional study conducted in the region. In the first cross sectional study, conducted in the winter of 2020, we aimed to estimate the seroprevalence of SARS-CoV-2 IgG antibodies among blood donors in Sarajevo Canton. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Seroprevalence, Antibody, COVID-19
- How many people
- 1,152 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 17 Nov 2021to 31 Dec 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment will be convenience sampling of blood donors aged between 18 and 65 years. All blood donors visiting the Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina for routine blood donation will be approached during the study period to participate in the study by the staff (medical doctors) of Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina at time of donation. Some blood donors will also be called by the staff of the Institute for Transfusion Medicine during the routine actions for donation of missing blood types, from an existing list maintained by staff at the Institute for Transfusion Medicine, and will be also invited to participate in the study by staff upon attendance at the blood clinic. Investigators will endeavor to ensure that the following three age groups can be reported: 18-29, 30-39, 40-65.
Who may be able to join
- All individuals identified for recruitment into the investigation, resident of Canton Sarajevo between 18-65 years, irrespective of prior COVID-19 infection.
Who cannot join
- Refusal to give informed consent or to attend follow-up appointments; currently experiencing COVID-19 symptoms or in the last 14 days; and close contact with a confirmed case of COVID-19 within 14 days prior to donation.
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina
Sarajevo, 71000
Sanjin Musa, MD, s.musa@zzjzfbih.ba
About this study
This study is the second cross-sectional study conducted in the region. In the first cross sectional study, conducted in the winter of 2020, we aimed to estimate the seroprevalence of SARS-CoV-2 IgG antibodies among blood donors in Sarajevo Canton. We also assessed immune durability among seropositive participants after 6 months. In total, of 1015 blood donors aged 18-65 years in Sarajevo Canton between 2 November and 3 December 2020 were recruited and population-weighted seroprevalence in Sarajevo Canton was 19.2% (95% CI: 16.7-21.6%). The aim of this second cross-sectional study is to measure the seroprevalence SARS-CoV-2 antibodies and assess antibody kinetics in the blood donor population after 12 months.
- Conditions
- Seroprevalence, Antibody, COVID-19
- 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 |
|---|---|---|
| Persons aged 18-29 | Not described | |
| Persons aged 30-39 | Not described | |
| Persons aged 40-65 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence of SARS-CoV-2 IgG antibodies
Crude seroprevalence among blood donors will be adjusted to age and sex distribution in cantonal population and to test sensitivity and specificity using Bayesian statistical modeling.
Measured: November 2021-December 2021
Secondary outcomes (2)
Assess factors associated with seropositivity.
Chi-squared test will be conducted on categorical variables.
Measured: November 2021-December 2021
Assess antibody response across types of immunity.
Among those with positive anti-S antibodies, geometric mean titers will be compared across participants with natural immunity, vaccine-induced immunity, and hybrid of natural and vaccine-induced immunity.
Measured: November 2021-December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start17 Nov 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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 SeroprevalenceStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Public Health of the Federation of Bosnia and Herzegovina
- Sponsor type
- Other government
- Collaborators
- World Health Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124535
- Sponsor's protocol ID
- 001
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the data is shared by the implementing organization to WHO or any agency or institution providing support for data analysis, data shared will include only the study identification number and not any personally identifiable information.
Publications
Musa S, Catovic Baralija E, Ivey Sawin V, Nardone A, Palo M, Skocibusic S, Blazevic M, Cilovic Lagarija S, Ahmetovic-Karic G, Ljuca A, Dostovic-Halilovic S, Nedic R, Subissi L, Ibrahim R, Boshevska G, Bergeri I, Pebody R, Vaughan A. Evolution of seroprevalence to SARS-CoV-2 in blood donors in Sarajevo Canton, Federation of Bosnia and Herzegovina: Cross-sectional and longitudinal studies. Influenza Other Respir Viruses. 2023 Aug 22;17(8):e13182. doi: 10.1111/irv.13182. eCollection 2023 Aug.
PubMed 37621919
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-based Age-stratified Seroepidemiological Investigation Protocol for Coronavirus 2019 (COVID-19) Infection in the Federation of Bosnia and Herzegovina
- ClinicalTrials.gov ID
- NCT05124535
- Acronym / sponsor ID
- 001
- Conditions
- Seroprevalence, Antibody, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,152 participants (estimated)
- Lead sponsor
- Institute for Public Health of the Federation of Bosnia and HerzegovinaOther government
- Collaborators
- World Health Organization
- Study start
- 17 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Nov 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 study is the second cross-sectional study conducted in the region. In the first cross sectional study, conducted in the winter of 2020, we aimed to estimate the seroprevalence of SARS-CoV-2 IgG antibodies among blood donors in Sarajevo Canton. We also assessed immune durability among seropositive participants after 6 months. In total, of 1015 blood donors aged 18-65 years in Sarajevo Canton between 2 November and 3 December 2020 were recruited and population-weighted seroprevalence in Sarajevo Canton was 19.2% (95% CI: 16.7-21.6%). The aim of this second cross-sectional study is to measure the seroprevalence SARS-CoV-2 antibodies and assess antibody kinetics in the blood donor population after 12 months.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Persons aged 18-29 | – | – |
| Persons aged 30-39 | – | – |
| Persons aged 40-65 | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be convenience sampling of blood donors aged between 18 and 65 years. All blood donors visiting the Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina for routine blood donation will be approached during the study period to participate in the study by the staff (medical doctors) of Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina at time of donation. Some blood donors will also be called by the staff of the Institute for Transfusion Medicine during the routine actions for donation of missing blood types, from an existing list maintained by staff at the Institute for Transfusion Medicine, and will be also invited to participate in the study by staff upon attendance at the blood clinic. Investigators will endeavor to ensure that the following three age groups can be reported: 18-29, 30-39, 40-65.
Key inclusion criteria (1 listed)
- All individuals identified for recruitment into the investigation, resident of Canton Sarajevo between 18-65 years, irrespective of prior COVID-19 infection.
Key exclusion criteria (1 listed)
- Refusal to give informed consent or to attend follow-up appointments; currently experiencing COVID-19 symptoms or in the last 14 days; and close contact with a confirmed case of COVID-19 within 14 days prior to donation.
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
Seroprevalence of SARS-CoV-2 IgG antibodies
Time frame: November 2021-December 2021
Crude seroprevalence among blood donors will be adjusted to age and sex distribution in cantonal population and to test sensitivity and specificity using Bayesian statistical modeling.
2 secondary outcomes
Assess factors associated with seropositivity.
Time frame: November 2021-December 2021
Assess antibody response across types of immunity.
Time frame: November 2021-December 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Derived from this study: PubMed 37621919Musa S, Catovic Baralija E, Ivey Sawin V, Nardone A, Palo M, Skocibusic S, Blazevic M, Cilovic Lagarija S, Ahmetovic-Karic G, Ljuca A, Dostovic-Halilovic S, Nedic R, Subissi L, Ibrahim R, Boshevska G, Bergeri I, Pebody R, Vaughan A. Evolution of seroprevalence to SARS-CoV-2 in blood donors in Sarajevo Canton, Federation of Bosnia and Herzegovina: Cross-sectional and longitudinal studies. Influenza Other Respir Viruses. 2023 Aug 22;17(8):e13182. doi: 10.1111/irv.13182. eCollection 2023 Aug.
- Individual participant dataSharing planned: Undecided. If the data is shared by the implementing organization to WHO or any agency or institution providing support for data analysis, data shared will include only the study identification number and not any personally identifiable information.
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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.
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 Seroprevalence and Antibody, run by Institute for Public Health of the Federation of Bosnia and Herzegovina at 1 site in Bosnia and Herzegovina.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 2021. 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 Bosnia and Herzegovina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronica I Sawin, ScM (+38762022240, viveysawin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence of SARS-CoV-2 IgG antibodies (time frame: November 2021-December 2021). 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 NCT05124535, 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 18 Nov 2021.