Mucosal Immunity in Patients Diagnosed With SARS-CoV-2 Infection and Their Household Contacts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Mucosal antibodies
研究概览
简要总结
In this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. On the collected nose and throat swabs a coronavirus PCR was performed. Antibodies against SARS-CoV-2 were measured in the mucosal lining fluid and blood samples.
详细描述
Objective:
Primary Objective: to analyse the development of mucosal immunity against SARS-CoV-2 in nasal fluid of Covid-19 patients and their household contacts
Secondary Objective(s):
- To descriptively analyse the correlation of mucosal antibodies with viral diagnostics and disease symptoms
- To determine the correlation between mucosal and serum antibody levels
- To study the functionality of serum and mucosal antibodies
Study design: A single-site, observational, prospective cohort study among COVID-19 patients and their household contacts Study population: The study will be conducted among COVID-19 patients with a laboratory-confirmed infection with SARS-CoV-2, as well as household contacts remaining in home quarantine at the same address, among secondary and tertiary hospital careworkers in the provinces of Gelderland and Noord-Brabant in The Netherlands.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Index case:
- •Laboratory-confirmed case of SARS-CoV-2, with a positive indication for home isolation, and;
- •With at least 2 household contacts remaining in home quarantine at the same address
- •Household contacts For each index case, the study will seek to recruit as many household contacts as possible in the same house as the index case. All household contacts of the index case remaining in home quarantine in the same house as the index case will be asked to participate.
排除标准
- •Covid-19 patients with a negative indication for home isolation, or having less than 2 household contacts remaining in home quarantine at the same address. For fingerprick blood collection, participants who have a medical indication against fingerprick blood collection will be excluded.
结局指标
主要结局
Mucosal antibodies
时间窗: Day 14 (household contacts)
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Mucosal antibodies in all participants
时间窗: Day 28
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
次要结局
- Serum antibodies(day 28)
- SARS-CoV-2 infection(day 0)
- Functional antibody assays(Day 28)