Evaluation of Silver Nanoparticles for the Prevention of COVID-19

Sponsor

Cluster de Bioeconomia de Baja California, A.C (Other)

Overall Status

Completed

CT.gov ID

NCT04894409

Collaborator

Bionag SAPI de CV (Other), General Hospital Tijuana (Other)

231

Enrollment

Location

Arms

5.2

Actual Duration (Months)

44.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Disease 2019 (COVID-19)	Device: Mouthwash and nose rinse with the AgNPs solution Device: Mouthwashes and nose rinse in a conventional way	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

231 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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)

Primary Purpose:

Other

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

Actual Study Start Date :

Apr 24, 2020

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Sep 29, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of SARS-CoV-2 infection in the experimental group. [9 weeks]
Percentage of participants infected of SARS-CoV-2 in the experimental group.
Incidence of SARS-CoV-2 infection in the control group. [9 weeks]
Percentage of participants infected of SARS-CoV-2 in the control group.

Secondary Outcome Measures

Number of participants with adverse reactions by AgNPs. [9 weeks]
Number of participants with adverse reactions by performing mouthwash and nose rinse with AgNPs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 73 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tijuana General Hospital	Tijuana	Baja California	Mexico	22310

Sponsors and Collaborators

Cluster de Bioeconomia de Baja California, A.C
Bionag SAPI de CV
General Hospital Tijuana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Cluster de Bioeconomia de Baja California, A.C

ClinicalTrials.gov Identifier:

NCT04894409

Other Study ID Numbers:

CONBIOETICA-02-CEI-001-20170

First Posted:

May 20, 2021

Last Update Posted:

May 20, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Cluster de Bioeconomia de Baja California, A.C

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 20, 2021