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临床试验/NCT05244330
NCT05244330已完成不适用

Effectiveness of COVID-19 Vaccines Against the SARS-COV-2 Delta (B.1.617.2) in China-A Real World Study

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
1
主要终点
the proportion of severe and critical cases

研究概览

简要总结

Up to now, Corona Virus Disease 2019 (COVID-19) continues to spread rapidly around the world. From the beginning of the epidemic to the present, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has continuously evolved and mutated, producing transmissible and virulent variants. At present, the infection rate of Delta variant strains is still increasing globally. The epidemic strain of novel coronavirus infection in Xi 'an city is δ (B.1.617.2). SARS-CoV-2 Delta has more infectious, higher viral load and shorter incubation period than other SARS-COV-2 delta strains. Several studies have shown that the protective efficacy of vaccines against different SARS-COV-2 virus variants is different, and SARS-COV-2 viral load is closely related to transmission, clinical phenotype and prognosis of infected patients. According to the notice of Xi'an Municipal Health Commission, a total of 2,139 local confirmed cases were reported in Xi 'an on January 10,2022, and the proportion of severe cases was 2.36%, which was significantly lower than the 7% of nation since the second half of 2020. According to the preliminary investigation by the applicant's team, the severe illness rate in Xi'an has decreased significantly, which benefits from the active promotion of domestic vaccination, early intervention, and use of neutralizing antibodies. The purpose of this study is to analyze the effects of vaccination on nucleic acid turning negative, clinical characteristics and prognosis of patients infected with SARS-COV-2 delta, and to clarify the protective effects of vaccination, which is of great significance for the prevention and control of the SARS-COV-2 delta (B.1.617.2) in Xi' an.

详细描述

In this study, through follow-up of SARS-COV-2 Delta infection patients in Xi 'an, Shaanxi Province, China, exploring the effects of vaccination on nucleic acid turning negative, clinical characteristics and prognosis of patients infected with SARS-COV-2 Delta, so as to clarify the protective effects of vaccination on SARS-COV-2 Delta.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed with SARS-COV-2 Delta infection
  • Clear vaccination information
  • Plasma viral load measurements within 24 hours of admission to the hospital
  • Performing continuous plasma viral load measurements
  • Obtaining informed consent

排除标准

  • Pregnant women
  • Clinical diagnosis of organ dysfunction or failure before infection
  • Long-term use of immunosuppressants or immunodeficiency patients

结局指标

主要结局

the proportion of severe and critical cases

时间窗: during hospitalization, an average of 1 month

the proportion of severe and critical cases during hospitalization

次要结局

  • the duration of viral shedding(during hospitalization, an average of 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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