Evaluation of Silver Nanoparticles for the Prevention of COVID-19

NCT04894409 | Completed

• 1 other identifier: CONBIOETICA-02-CEI-001-20170
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease 2019 (COVID-19)

Keywords

Silver nanoparticles; SARS-CoV-2; COVID-19; Infection control

Outcome Measures

Primary Outcomes (2)

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

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

  9 weeks

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

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

  9 weeks

Secondary Outcomes (1)

• Number of participants with adverse reactions by AgNPs.

  9 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group was instructed to do mouthwash and nose rinse with the AgNPs solution.

Device: Mouthwash and nose rinse with the AgNPs solution

Control group

ACTIVE COMPARATOR

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

Device: Mouthwashes and nose rinse in a conventional way

Interventions

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

Experimental group

Mouthwashes and nose rinse in a conventional way DEVICE

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

Control group

Eligibility Criteria

• Age: 20 Years - 73 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cluster de Bioeconomia de Baja California, A.C: lead
• Bionag SAPI de CV: collaborator
• General Hospital Tijuana: collaborator

Study Sites (1)

Tijuana General Hospital

Tijuana, Estado de Baja California, 22310, Mexico

Location

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Related Links

• World Health Organization. Coronavirus disease (COVID-19) pandemic.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2021
• First Posted: May 20, 2021
• Study Start: April 24, 2020
• Primary Completion: June 30, 2020
• Study Completion: September 29, 2020
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)