Evaluation of Silver Nanoparticles for the Prevention of COVID-19 (COVID-19)
Primary Purpose
Coronavirus Disease 2019 (COVID-19)
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Mouthwash and nose rinse with the AgNPs solution
Mouthwashes and nose rinse in a conventional way
Sponsored by

About this trial
This is an interventional other trial for Coronavirus Disease 2019 (COVID-19) focused on measuring Silver nanoparticles, SARS-CoV-2, COVID-19, Infection control
Eligibility Criteria
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.
Sites / Locations
- Tijuana General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of SARS-CoV-2 infection in the experimental group.
Percentage of participants infected of SARS-CoV-2 in the experimental group.
Incidence of SARS-CoV-2 infection in the control group.
Percentage of participants infected of SARS-CoV-2 in the control group.
Secondary Outcome Measures
Number of participants with adverse reactions by AgNPs.
Number of participants with adverse reactions by performing mouthwash and nose rinse with AgNPs.
Full Information
NCT ID
NCT04894409
First Posted
May 16, 2021
Last Updated
May 18, 2021
Sponsor
Cluster de Bioeconomia de Baja California, A.C
Collaborators
Bionag SAPI de CV, General Hospital Tijuana
1. Study Identification
Unique Protocol Identification Number
NCT04894409
Brief Title
Evaluation of Silver Nanoparticles for the Prevention of COVID-19
Acronym
COVID-19
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cluster de Bioeconomia de Baja California, A.C
Collaborators
Bionag SAPI de CV, General Hospital Tijuana
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019 (COVID-19)
Keywords
Silver nanoparticles, SARS-CoV-2, COVID-19, Infection control
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Eligible participants for the in vivo study were randomized using a computer generated block scheme and stratified according to duty position, work shifts and the area/department of the service at General Tijuana Hospital. Individuals from experimental group were provided with a 50 mL spray bottle containing AgNPs solution with 1 wt% concentration (0.6 mg/mL metallic silver). Participants were instructed to mix 4 to 6 spray shots (corresponding to volume ~ 0.5 mL) of this solution with 20 mL of water and to gargle with obtained solution for 15 to 30 seconds at least 3 times a day, also nasal lavages on the inner part of the nasal alae and nasal passage with the same solution using a cotton swap twice a day. As a second option, participants were instructed to cover evenly the oral cavity with the direct 1 to 2 spray shots of solution without its previous dilution in water.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
231 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The experimental group was instructed to do mouthwash and nose rinse with the AgNPs solution.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The "control" group was instructed to do mouthwashes and nose rinse in a conventional way.
Intervention Type
Device
Intervention Name(s)
Mouthwash and nose rinse with the AgNPs solution
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Mouthwashes and nose rinse in a conventional way
Intervention Description
The control group was instructed to do mouthwashes and nose rinse in a conventional way
Primary Outcome Measure Information:
Title
Incidence of SARS-CoV-2 infection in the experimental group.
Description
Percentage of participants infected of SARS-CoV-2 in the experimental group.
Time Frame
9 weeks
Title
Incidence of SARS-CoV-2 infection in the control group.
Description
Percentage of participants infected of SARS-CoV-2 in the control group.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Number of participants with adverse reactions by AgNPs.
Description
Number of participants with adverse reactions by performing mouthwash and nose rinse with AgNPs.
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Tijuana General Hospital
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22310
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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URL
http://www.who.int/emergencies/diseases/novel-coronavirus-2019
Description
World Health Organization. Coronavirus disease (COVID-19) pandemic.
URL
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
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Centers for Disease Control and Prevention. Symptoms of Coronavirus.
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Evaluation of Silver Nanoparticles for the Prevention of COVID-19
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