Evaluation of Silver Nanoparticles for the Prevention of COVID-19
NCT ID: NCT04894409
Last Updated: 2021-05-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
231 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-04-24
Study Completion Date
2020-09-29
Brief Summary
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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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Detailed Description
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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.
Conditions
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Coronavirus Disease 2019 (COVID-19)
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
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.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Experimental group
The experimental group was instructed to do mouthwash and nose rinse with the AgNPs solution.
Group Type
EXPERIMENTAL
Mouthwash and nose rinse with the AgNPs solution
Intervention Type
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
Control group
The "control" group was instructed to do mouthwashes and nose rinse in a conventional way.
Group Type
ACTIVE_COMPARATOR
Mouthwashes and nose rinse in a conventional way
Intervention Type
DEVICE
The control group was instructed to do mouthwashes and nose rinse in a conventional way
Interventions
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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
Intervention Type
DEVICE
Mouthwashes and nose rinse in a conventional way
The control group was instructed to do mouthwashes and nose rinse in a conventional way
Intervention Type
DEVICE
Eligibility Criteria
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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.
* 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.
Minimum Eligible Age
20 Years
Maximum Eligible Age
73 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Bionag SAPI de CV
UNKNOWN
Sponsor Role
collaborator
General Hospital Tijuana
UNKNOWN
Sponsor Role
collaborator
Cluster de Bioeconomia de Baja California, A.C
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Tijuana General Hospital
Tijuana, Estado de Baja California, Mexico
Site Status
Countries
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Mexico
References
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Related Links
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http://www.who.int/emergencies/diseases/novel-coronavirus-2019
World Health Organization. Coronavirus disease (COVID-19) pandemic.
Other Identifiers
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CONBIOETICA-02-CEI-001-20170
Identifier Type: -
Identifier Source: org_study_id
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