COVID-19 Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 1152 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Bosnia and Herzegovina | Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina | Sarajevo |
| Lead Sponsor | Collaborator |
|---|---|
| Institute for Public Health of the Federation of Bosnia and Herzegovina | World Health Organization |
Bosnia and Herzegovina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Assess factors associated with seropositivity. | Chi-squared test will be conducted on categorical variables. | November 2021-December 2021 | |
| Secondary | 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 |
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