Characterizing the Immune Response and Neuronal Damage in SARS-CoV-2 Infected Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Innate immune response to SARS-Cov-2
研究概览
简要总结
The Investigators plan to study the innate and adaptive immune response, the inflammatory response, and associated complications such as complement activation and neurological damage in SARS-Cov-2 infected individuals. Patients with mild, moderate and severe COVID-19 disease will be enrolled.
详细描述
The severity of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to severe illness requiring mechanical ventilation. Immunological factors which lead to severe disease in certain COVID-19 patients remain incompletely understood. Neurological damage and complement activation may be a consequence of excess inflammation in severe COVID-19. The investigators plan to study the innate and adaptive immune response and potentially associated complications such as neurological damage and complement activation in mild, moderate and severe COVID-19 courses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •PCR confirmed SARS-Cov-2 infection
排除标准
- •Refusal to participate
- •Age < 18 years
结局指标
主要结局
Innate immune response to SARS-Cov-2
时间窗: 5 days after enrollment
Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Cell mediated immune response
时间窗: 28 days (+/-7) after enrollment
Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
Cytokine response to SARS-Cov-2
时间窗: 28 days (+/-7) after enrollment
Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)
Humoral immune response
时间窗: At enrollment
Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)
Neurological damage
时间窗: 28 days (+/-7) after enrollment
Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)
次要结局
- Complement activation(28 days (+/-7) after enrollment)