Prospective, One Center, Four Groups, Open, Comparative, Controlled Study to Explore T Cells Response to SARS COV 2 Peptides by Metabolic Activity Method in Convalesce and Healthy Individuals Versus Antibody Response
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR)
研究概览
简要总结
The analysis method described in this protocol is a novel simple plausible immunological approach which is non-invasive, high throughput, real-time quantitative monitoring of metabolic activity (MA) profiles of fresh Peripheral Blood Mononuclear Cells (PBMC) in response to various reagents at different concentrations. The purpose of this study is to evaluate the T cells reactivity to SARS COV 2 immunogenic selected peptides by Metabolic Activity Method in convalesce and healthy individuals and to compare it with Antibody response (ELISA) and clinical information
详细描述
This is a prospective, four groups, open, comparative, controlled study. A total of 400 completed, evaluated subjects will be enrolled in this study. Main Study Measures: Reactivity of T cells to selected SARS COV-2 peptides by MA test and IgG Antibody response to SARS COV-2 by commercial ELISA test.
Study Procedures:
- Screening
- Informed consent signing
- Medical history review
- Blood collection.
- MA test and ELISA test will be performed at Savicell's Laboratory site.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •All recruited subjects are between 18 to 90 years old.
- •All recruited subjects read the informed consent and then signed the informed consent.
- •All recruited subjects filled out the questionnaire form
排除标准
- •Subject has active infection or inflammation determined clinically at screening.
- •Subject is currently treated with concomitant medication related directly or can affect the immune system as steroids.
- •Subject has impaired judgment.
- •Known positive HIV, hepatitis B, or hepatitis C, autoimmune disease.
- •Known history of a significant medical disorder, which in the investigators' judgment contraindicates the patient's participation.
- •Drug or alcohol abuse
- •Subject is participating in any other clinical trial for drug investigation within 10 days prior sample collection
结局指标
主要结局
Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR)
时间窗: week
T cells reactivity to SARS COV 2 immunogenic
次要结局
- Prevalence of positive for SARS - COV2 - in healthy donors.(week)