Population-based Age-stratified Seroepidemiological Investigation Protocol for Coronavirus 2019 (COVID-19) Infection in 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: Not yet recruiting
• Conditions: COVID-19; Antibody; Seroprevalence

• Study Type: Observational
• Enrollment (Anticipated): 1152

Contacts and Locations

• Study Contact: Name: Veronica I Sawin, ScM; Phone Number: +38762022240; Email: viveysawin@gmail.com

Study Locations

• Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina
    • Contact: Sanjin Musa, MD; Email: s.musa@zzjzfbih.ba

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Persons aged 18-29
Persons aged 30-39
Persons aged 40-65

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	November 2021-December 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess factors associated with seropositivity.	Chi-squared test will be conducted on categorical variables.	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.	November 2021-December 2021

Collaborators and Investigators

• Sponsor: Institute for Public Health of the Federation of Bosnia and Herzegovina
• Collaborators: World Health Organization

Study record dates

Study Major Dates

• Study Start (Anticipated): November 17, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

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