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Evaluation of Silver Nanoparticles for the Prevention of COVID-19 (COVID-19)

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ClinicalTrials.gov Identifier: NCT04894409
Recruitment Status : Completed
First Posted : May 20, 2021
Last Update Posted : May 20, 2021
Sponsor:
Collaborators:
Bionag SAPI de CV
General Hospital Tijuana
Information provided by (Responsible Party):
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.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : April 24, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : September 29, 2020

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




Primary Outcome Measures :
  1. Incidence of SARS-CoV-2 infection in the experimental group. [ Time Frame: 9 weeks ]
    Percentage of participants infected of SARS-CoV-2 in the experimental group.

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


Secondary Outcome Measures :
  1. Number of participants with adverse reactions by AgNPs. [ Time Frame: 9 weeks ]
    Number of participants with adverse reactions by performing mouthwash and nose rinse with AgNPs.



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Ages Eligible for Study:   20 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894409


Locations
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Mexico
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
Additional Information:
Publications:

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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    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cluster de Bioeconomia de Baja California, A.C:
Silver nanoparticles
SARS-CoV-2
COVID-19
Infection control
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases