Population-based Age-stratified Seroepidemiological Investigation Protocol for Coronavirus 2019 (COVID-19) Infection in the Federation of Bosnia and Herzegovina

November 16, 2021 updated by: Institute for Public Health of the Federation of Bosnia and Herzegovina
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • All individuals identified for recruitment into the investigation, resident of Canton Sarajevo between 18-65 years, irrespective of prior COVID-19 infection.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Persons aged 18-29
Persons aged 30-39
Persons aged 40-65

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
November 2021-December 2021

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess factors associated with seropositivity.
Time Frame: November 2021-December 2021
Chi-squared test will be conducted on categorical variables.
November 2021-December 2021
Assess antibody response across types of immunity.
Time Frame: November 2021-December 2021
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.
November 2021-December 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute for Public Health of the Federation of Bosnia and Herzegovina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Health Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001 (Marta Eliza Miller Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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