跳至主要内容
临床试验/NCT05748262
NCT05748262Enrolling By Invitation不适用

Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China;

Jiming Zhang1 个研究点 分布在 1 个国家目标入组 1,144 人开始时间: 2022年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,144
试验地点
1
主要终点
Characteristics of all enrolled SARS-CoV-2 patients during two periods.

研究概览

简要总结

As the COVID-19 pandemic continues and the number of individuals with previous infection rises, numbers of SARS-CoV-2 reinfection are increasing. The second Omicron wave in Shanghai, China caused by BA.5-sublineages led to a large fraction of reinfections among BA.2 primary infections. To better understand the SARS-CoV-2 reinfection rate and clinical severity of reinfections, the investigators conducted a multi-centre cohort study. The investigators hope to provide valuable clinical evidences for reinfections and offer guidance for future policy making.

详细描述

The investigators used data from Huashan Hospital, Renji Hospital, and Shanghai Jing' an Central Hospital to collect information on SARS-CoV-2 primary infections with BA.2 during 1 March to 23 May 2022, and followed up for participants' reinfections with BA.5-lineages during 1 December 2022 to 14 January 2023. After matched 1:1 by age and gender with the reinfection cohort, data of primary infections with BA.5-sublineages were also collected. Reinfection cases were defined as having positive COVID-19 PCR or antigen test, at least 90 days after participants' first positive testing. Basic information, vaccination status, time interval between two infections, and clinical manifestations were collected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All PCR- or RAT-confirmed SARS-CoV-2 reinfections were included in the study.

排除标准

  • Patients who did not know if they were reinfected were excluded.

结局指标

主要结局

Characteristics of all enrolled SARS-CoV-2 patients during two periods.

时间窗: 2022-12~2023-2

Basic information, vaccination status, time interval between two infections, and clinical manifestations

Characteristics and multivariate analysis of risk factors for SARS-CoV-2 reinfection by gender, age, vaccination status, clinical severity and Ct values of primary infection.

时间窗: 2022-12~2023-2

Sex, age, vaccination status, clinical severity of primary infection, and Ct values during primary infection

Clinical characteristics of SARS-CoV-2 primary infection and reinfection among patients with reinfection in Shanghai

时间窗: 2022-12~2023-2

Fever, fatigue, sore throat, cough, anosmia and/or ageusia, muscle and/or joint pain, headache, chest congestion, diarrhea, runny nose, sleeping disorders, and pneumonia

次要结局

未报告次要终点

研究者

发起方
Jiming Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jiming Zhang

professor

Huashan Hospital

研究点 (1)

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