Evaluation of Silver Nanoparticles for the Prevention of COVID-19 (COVID-19)

May 18, 2021 updated by: Cluster de Bioeconomia de Baja California, A.C

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Baja California
      • Tijuana, Baja California, Mexico, 22310
        • Tijuana General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The experimental group was instructed to do mouthwash and nose rinse with the AgNPs solution.
Device: Mouthwash and nose rinse with the AgNPs solution
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
Active Comparator: Control group
The "control" group was instructed to do mouthwashes and nose rinse in a conventional way.
Device: Mouthwashes and nose rinse in a conventional way
The control group was instructed to do mouthwashes and nose rinse in a conventional way

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 weeks
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.
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cluster de Bioeconomia de Baja California, A.C

Collaborators

Bionag SAPI de CV
General Hospital Tijuana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

September 29, 2020

Study Registration Dates

First Submitted

May 16, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONBIOETICA-02-CEI-001-20170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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