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Evaluation of Silver Nanoparticles for the Prevention of COVID-19

Not Applicable
Completed
Conditions
Coronavirus Disease 2019 (COVID-19)
Interventions
Device: Mouthwash and nose rinse with the AgNPs solution
Device: Mouthwashes and nose rinse in a conventional way
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.

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
Arm && Interventions
GroupInterventionDescription
Experimental groupMouthwash and nose rinse with the AgNPs solutionThe experimental group was instructed to do mouthwash and nose rinse with the AgNPs solution.
Control groupMouthwashes and nose rinse in a conventional wayThe "control" group was instructed to do mouthwashes and nose rinse in a conventional way.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

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