The Risk of SARS-CoV-2 Infection and Severity of COVID-19 Among Healthcare Workers With or Without Previous COVID-19 Vaccines
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 infection
研究概览
简要总结
At present, COVID-19 vaccine is considered as the safest, economic and effective measure to prevent and control COVID-19. Adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. Cellular immunity includes virus specific B cells and T cells, which can provide long-term memory immunity. For acute viral infection, neutralizing antibody is of great significance in preventing infection, while memory cell immunity can maintain a good broad-spectrum and persistence in controlling mutant strains, which is a key factor in controlling viral replication after infection and reducing severe disease and death. However, there is no systematic study on the specific immune response and infection risk of novel coronavirus, and there is no definite conclusion on which specific protective immune response induced by vaccine can reduce the risk of infection. Therefore, this study aims to establish a prospective real-world cohort, analyze the correlation between multiple baseline immune protection indicators and infection risk, follow up the population with breakthrough infection, and monitor the dynamic specific immune response to COVID-19 in peripheral blood and respiratory mucosa. This study will provide an important scientific basis for us to scientifically assess the risk of individual infection with COVID-19.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •SARS-CoV-2 nucleic acid testing showed negative within 72 hours
排除标准
- •1.Do not consent to enroll in this study
结局指标
主要结局
SARS-CoV-2 infection
时间窗: from Dec 2022 to April 2023
SARS-CoV-2 infection confirmed by either by nucleic acid testing or antigen testing
The severity of COVID-19
时间窗: from Dec 2022 to April 2023
the severity of COVID-19 symptoms including the period from SARS-CoV-2 positive to negative, fever days, etc.
次要结局
未报告次要终点
研究者
Chao Wu
Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
