跳至主要内容
临床试验/NCT05680896
NCT05680896招募中不适用

The Risk of SARS-CoV-2 Infection and Severity of COVID-19 Among Healthcare Workers With or Without Previous COVID-19 Vaccines

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年2月1日最近更新:
适应症

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

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

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chao Wu

Professor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

Loading locations...

相似试验