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Completed

NCT Number: NCT04894409

Evaluation of Silver Nanoparticles for the Prevention of COVID-19

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.

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Key information

Age range

20 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tijuana General Hospital

Tijuana, Estado de Baja California, 22310, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mouthwash and nose rinse with the AgNPs solution

Device

The "experimental" group was instructed to do mouthwash and nose rinse with the AgNPs solution for the prevention of SARS-CoV-2 infection in health workers

Mouthwashes and nose rinse in a conventional way

Device

The control group was instructed to do mouthwashes and nose rinse in a conventional way

Primary outcomes

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

    Time frame: 9 weeks

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

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

    Time frame: 9 weeks

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

Secondary outcomes

  1. Number of participants with adverse reactions by AgNPs.

    Time frame: 9 weeks

    Number of participants with adverse reactions by performing mouthwash and nose rinse with AgNPs.

Sponsors and collaborators

Lead sponsor

Cluster de Bioeconomia de Baja California, A.C

Other

Collaborators

  • Bionag SAPI de CV
  • General Hospital Tijuana

Registry information

Official study title

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

Acronym: COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 20, 2021
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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