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临床试验/NCT04408001
NCT04408001已完成不适用

Study of Kinetics and Efficacy of the Immune Response Against COVID-19 Among Hospital Staff

Direction Centrale du Service de Santé des Armées1 个研究点 分布在 1 个国家目标入组 499 人开始时间: 2020年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
499
试验地点
1
主要终点
Induced SARS-CoV2 immunity

研究概览

简要总结

COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff.

A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic.

Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool.

Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding.

The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years of age or older;
  • •Military or civilian or contactual volunteer on duty at Percy hospital during the COVID-19 pandemic.

排除标准

  • •Individuals who have displayed a severe form of early-onset COVID-19 who required intensive care management or hospitalization;
  • •Presence of factors modulating immunity with congenital or acquired immunosuppression:
  • •Medication: cancer chemotherapy, immunosuppressive drugs, biotherapy, corticosteroids
  • •Uncontrolled HIV infection or CD4 <200/mm3 infection
  • •History of solid organ or hematopoietic stem cell transplants

结局指标

主要结局

Induced SARS-CoV2 immunity

时间窗: At day 21 (compared to enrollment [Day 0])

The presence of induced immunity will be identified by an Ig family switch on the first two serologies with a high titre of specific IgG and disappearance of IgM.

Long-term protection of induced SARS-CoV2 immunity at 6 months

时间窗: 6 months following enrollment

The presence of induced immunity will be identified on serology analysis at 6 months.

Long-term protection of induced SARS-CoV2 immunity at 1 year

时间窗: 1 year following enrollment

The presence of induced immunity will be identified on serology analysis at 1 year.

Anti-SARS-CoV2 antibodies kinetics in saliva throughout the study

时间窗: From enrollment (Day 0) to 1 year after enrollement

Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on saliva samples from enrollment (Day 0) to 1 year after enrollement

Anti-SARS-CoV2 antibodies kinetics in blood throughout the study

时间窗: From enrollment (Day 0) to 1 year after enrollement

Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement

Kinetics of serum neutralization in blood throughout the study

时间窗: From enrollment (Day 0) to 1 year after enrollement

Kinetics of serum neutralization against SARS-CoV-2 positive using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement.

次要结局

  • Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 0(At enrollment (Day 0))
  • Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 21(At Day 21)

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

研究点 (1)

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