Evaluation of Silver Nanoparticles for the Prevention of COVID-19

Coronavirus Disease 2019 (COVID-19) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894409
• Other study ID #: CONBIOETICA-02-CEI-001-20170
• Status: Completed
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: September 29, 2020

Study information

• Verified date: May 2021
• Source: Cluster de Bioeconomia de Baja California, A.C
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: September 29, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 73 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019 (COVID-19)
• Coronavirus Infections

Intervention

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

Locations

Country	Name	City	State
Mexico	Tijuana General Hospital	Tijuana	Baja California

Sponsors (3)

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

Country where clinical trial is conducted

Mexico, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SARS-CoV-2 infection in the experimental group.	Percentage of participants infected of SARS-CoV-2 in the experimental group.	9 weeks
Primary	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	Number of participants with adverse reactions by AgNPs.	Number of participants with adverse reactions by performing mouthwash and nose rinse with AgNPs.	9 weeks

External Links

•   Centers for Disease Control and Prevention. Symptoms of Coronavirus.
•   World Health Organization. Coronavirus disease (COVID-19) pandemic.