Study SARS-CoV-2-CZ-PREVAL-II - Arm of the Olomouc Region Study to Quantify the Presence of Antibodies and Cellular Immunity Against SARS-CoV-2 in the Population of Persons Participating in the SARS-CoV-2-CZ-PREVAL Study in 2020
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- The Institute of Molecular and Translational Medicine, Czech Republic
- 入组人数
- 2,484
- 试验地点
- 1
- 主要终点
- The proportion of people in the population of the Olomouc Region with the presence of antibodies against the SARS-CoV-2 virus
概览
简要总结
The aim of the study is to find the proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have undergone vaccination against COVID-19.
详细描述
Study has three study visits. First two visits are three months apart. Second and third visits are five months apart. On each study visit participant will provide venous blood sample and saliva sample obtained by gargling with the use of GARGTEST sampling kit. Participant will also fill in a questionnaire about SARS-CoV-2 infections and vaccinations. Site staff will measure the body temperature of the patient to exclude a patient with an acute infection. Blood sample will be used for the assessment of antibodies and cellular immunity of SARS-CoV-2. Part of the blood will be biobanked for the future SARS-CoV-2 biomarker determination. Gargling sample will be used for the demonstration of the pathogen on mucous membranes. Gargle self-sampling using GARGTEST sampling kit will be done by participants at 14-day intervals between the study visits. For gargle sample RT-PCR (real time polymerase chain reaction) will be done to determine the patogen presence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation in the SARS-CoV-2-CZ-PREVAL study and venous blood examined as part of this study
- •Signed study informed consent and consent to the processing of personal data
- •Adults (age 18 and over)
- •Willingness to complete the questionnaire
排除标准
- •Participant with acute health problems
研究组 & 干预措施
Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region
Population of persons involved in the SARS-CoV-2-CZ-Preval study in 2020 in the Olomouc region
干预措施: Blood sampling (Procedure)
Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region
Population of persons involved in the SARS-CoV-2-CZ-Preval study in 2020 in the Olomouc region
干预措施: Gargle sampling (Procedure)
Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region
Population of persons involved in the SARS-CoV-2-CZ-Preval study in 2020 in the Olomouc region
干预措施: Questionnaire completion (Other)
Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region
Population of persons involved in the SARS-CoV-2-CZ-Preval study in 2020 in the Olomouc region
干预措施: Body temperature measurement (Diagnostic Test)
结局指标
主要结局
The proportion of people in the population of the Olomouc Region with the presence of antibodies against the SARS-CoV-2 virus
时间窗: 12 months
The proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have undergone vaccination against COVID-19.
次要结局
- Quantification of the level/presence of cellular immunity(12 months)
- Verification of the presence of the SARS-CoV-2 virus(12 months)
- Proportion of people with an asymptomatic course of SARS-CoV-2 disease(12 months)
- Quantification of the presence of antibodies and the presence of cellular immunity(12 months)