Evaluation of Silver Nanoparticles for the Prevention of COVID-19

Not Applicable

Completed

• Conditions: Coronavirus Disease 2019 (COVID-19)

• Registration Number: NCT04894409
• Lead Sponsor: Cluster de Bioeconomia de Baja California, A.C

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.

Study Timeline

• Study Start: 2020-04-24
• Primary Completion: 2020-06-30
• Study Completion: 2020-09-29
• Status Verified: 2021-05
• Study First Submitted: 2021-05-16
• Study First Submitted QC: 2021-05-18
• Last Update Submitted: 2021-05-18
• Study First Posted: 2021-05-20
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Incidence of SARS-CoV-2 infection in the control group.	9 weeks	Percentage of participants infected of SARS-CoV-2 in the control group.
Incidence of SARS-CoV-2 infection in the experimental group.	9 weeks	Percentage of participants infected of SARS-CoV-2 in the experimental group.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse reactions by AgNPs.	9 weeks	Number of participants with adverse reactions by performing mouthwash and nose rinse with AgNPs.

Trial Locations

Locations (1)

Tijuana General Hospital; 🇲🇽 Tijuana, Baja California, Mexico