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临床试验/NCT04894409
NCT04894409已完成不适用

Evaluation of Silver Nanoparticles as an Oropharyngeal Product (Mouthwash) and Nasal Hygiene, by Health Personnel Working at the Tijuana General Hospital Exposed to Patients Diagnosed With Atypical Pneumonia Caused by SARS-CoV-2

Cluster de Bioeconomia de Baja California, A.C2 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2020年4月24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
231
试验地点
2
主要终点
Incidence of SARS-CoV-2 infection in the control group.

研究概览

简要总结

In this research, silver nanoparticles (AgNPs) were tested in vitro and shown to have an inhibitory effect on SARS-CoV-2 infection in cultured cells. Subsequently, the investigators assessed the effects of mouthwash and nose rinse with ARGOVIT® silver nanoparticles (AgNPs), in the prevention of SARS-CoV-2 contagion in health workers consider as high-risk group of acquiring the infection in the General Tijuana Hospital, Mexico, a hospital for the exclusive recruitment of patients diagnosed with COVID-19.

详细描述

SARS-CoV-2 infection in hospital areas is of a particular concern, since the close interaction between health care personnel and patients diagnosed with COVID-19, which allows virus to be easily spread between them and subsequently to their families and communities. Preventing SARS-CoV-2 infection among healthcare personnel is essential to reduce the frequency of infections and outbreaks during the pandemic. In a first step, silver nanoparticles (AgNPs) were tested in vitro to determine an inhibitory effect on SARS-CoV-2 infection in cultured cells. Subsequently, the investigators assess the effects of mouthwash and nose rinse with ARGOVIT® silver nanoparticles (AgNPs), in the prevention of SARS-CoV-2 contagion in health workers consider as high-risk group of acquiring the infection in the General Tijuana Hospital, Mexico, a hospital for the exclusive recruitment of patients diagnosed with COVID-19. The investigators present a prospective randomized study of 231 participants that was carried out for 9 weeks (during the declaration of a pandemic). The "experimental" group was instructed to do mouthwash and nose rinse with the AgNPs solution; the "control" group was instructed to do mouthwashes and nose rinse in a conventional way.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 73 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women health workers in the General Tijuana Hospital, Mexico who works in high-risk areas with direct contact with patients infected and diagnosed with COVID-19.

排除标准

  • persons with history of hypersensitivity to silver (rashes and other contraindications),
  • a history of SARS-CoV-2 infection in the three months prior to the start of the study, any respiratory distress,
  • and refusal to sign the informed consent.

结局指标

主要结局

Incidence of SARS-CoV-2 infection in the control group.

时间窗: 9 weeks

Percentage of participants infected of SARS-CoV-2 in the control group.

Incidence of SARS-CoV-2 infection in the experimental group.

时间窗: 9 weeks

Percentage of participants infected of SARS-CoV-2 in the experimental group.

次要结局

  • Number of participants with adverse reactions by AgNPs.(9 weeks)

研究者

发起方
Cluster de Bioeconomia de Baja California, A.C
申办方类型
Other
责任方
Sponsor

研究点 (2)

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