Immunological Characteristics of COVID-19 Patients and Determination of Neutralizing Antibodies Against SARS-CoV-2 Virus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Immunological changes during and after COVID-19 infection
研究概览
简要总结
The study will look at the immunological characteristics of COVID-19 patients and determine neutralizing antibodies against SARS-CoV-2 virus.
详细描述
The immunogram (quantitative TBNK immunophenotipisation) will be performed by flow cytometry, the antibody response will be determined by IVD ELISa.
Clinical biochemical and immunochemical (ECLIA) tests (including IL-6) will be performed on Cobas analyzers. Hemogram with differential blood picture will be performed with a hematology analyzer Sysmex XN 3100, examination of blood smears with CellaVision system or. microscope. Coagulation tests will be performed on BCS XP analyzers.
An in-house system for the analysis of SARS-CoV-2 virus fusion inhibitors on human cells will be used to detect the ability of antibodies from patients' serum to neutralize the virus and thus potential protection against re-infection. The system is quantitative, meaning that the titer of such antibodies could be determined, and thus the potential level of protection would be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written consent before being included in the essay.
- •Positive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2).
排除标准
- •Patients who are unable to give consent or who are unable to follow up will be excluded.
结局指标
主要结局
Immunological changes during and after COVID-19 infection
时间窗: July 2022
Correlation between TBNK dynamic and increase of neutralising antibodies
次要结局
未报告次要终点
研究者
Peter Korošec
Assoc Prof Peter Korošec, BSc (Biol), PhD
The University Clinic of Pulmonary and Allergic Diseases Golnik