NCT04633915已完成不适用
A Comparison of Antibody Response Against SARS-CoV-2 in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.
Saint Petersburg State University, Russia1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2020年11月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Anti-SARS-COV-2 IgG level
研究概览
简要总结
This is prospective cohort study aimed to compare antibody response against SARS-CoV-2 in dialysis patients and non-dialysis-dependent volunteers.
The research hypothesis is that dynamic of IgG antibodies against SARS-CoV-2 will differ in two groups.
To determine whether there is a statistically significant interaction between factors "group" and "time" on the titer of IgG antibodies against SARS-CoV-2, a two-way repeated measures ANOVA will be used.
详细描述
In both groups level of IgG antibodies against SARS-CoV-2 will be measured at the Day 1 (10 weeks from the date of first symptoms), Weeks 8 and 16 from the Day 1.
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
- •Age 18 years or older
- •SARS-CoV-2 infection within 10 weeks prior enrollment, confirmed by PCR or strongly suspected on computed tomography
- •Providing informed consent
排除标准
- •Refusal to provide informed consent
结局指标
主要结局
Anti-SARS-COV-2 IgG level
时间窗: 16 weeks
次要结局
- Proportion of people with detectable Anti-SARS-COV-2 IgG in study groups(Day 1, weeks 8, 16)
- Anti-SARS-COV-2 IgG level(8 weeks)
研究者
Ekaterina Parshina
Principal investigator, MD
Saint Petersburg State University, Russia
研究点 (1)
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