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临床试验/NCT05445479
NCT05445479撤回不适用

Retrospective Study to Identify Whether Doxycycline in SARS-CoV-2 Infection Protects Against Progression to a Severe Form.

Nantes University Hospital0 个研究点目标入组 10,000 人开始时间: 2022年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
入组人数
10,000
主要终点
Number of hospitalization associated with COVID-19

研究概览

简要总结

A new coronavirus, the third documented animal-to-human passage, emerged in Wuhan , China in the last quarter of 2019. Acne patients on doxycycline escaped seasonal viruses, showing the interest of this antibiotic as a possible treatment against COVID-19.

The antiviral action of tetracyclines can be explained by different mechanisms. First of all, tetracyclines are modulators of innate immunity by decreasing NF-B expression, inhibiting inflammatory cytokines such as TNF-α, IL-1β and IL-6, inflammatory granulomas and free radical release . This action is obtained at doses lower than those necessary to obtain an antibiotic effect. Another possible action of tetracyclines is their ability to chelate zinc from matrix metalloproteinases (MMPS). The coronavirus family is known to bind to host MMPs, particularly for viral survival. Their chelating activity may help inhibit SARS-CoV-2 infection by limiting its ability to replicate in the host. Finally, tetracyclines could have a direct action by inhibiting the replication of single-stranded RNA virus, such as the SARS-CoV-2 coronavirus.We therefore propose a larger comparative study using data from the French National Health Data System.

详细描述

DOXY-COVID study is a national, observational, retrospective cohort study to compare the risk of severe COVID-19 in doxycycline-treated patients versus non-doxycycline-treated control patients (so-called case-cohort study).

The patient inclusion period corresponds to the main waves associated with the COVID-19 epidemic in France, i.e. from January 1, 2020 to November 30, 2021. Indeed, the time of data access, expected during 2022, would not allow reasonable follow-up of doxycycline-exposed patients from December 1, 2021.

Data of interest collected on these patients are requested over the period from January 1, 2016, through December 31, 2021:

  • From January 1, 2016, in order to be able to define a pre-exposure phenotype over a follow-up period of at least 4 years in the French Health Insurance databases (period 2016-2019 inclusive)
  • Until December 31, 2021, in order to have at least one month's hindsight on the risk of occurrence of severe forms of COVID-19

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or female, ≥ 12 years old
  • •Affiliated with the French social security system or equivalent system
  • •Having been dispensed oral doxycycline at a dose of 100 mg between January 1, 2020 and November 30, 2021

排除标准

  • 未提供

结局指标

主要结局

Number of hospitalization associated with COVID-19

时间窗: January 1, 2020 to November 30, 2021

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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