Clinical trial NCT04894409: Evaluation of Silver Nanoparticles for the Prevention of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Disease 2019 (COVID-19)
Keywords: Silver nanoparticles
SARS-CoV-2
COVID-19
Infection control
Lead sponsor: Cluster de Bioeconomia de Baja California, A.C
Sponsor class: OTHER
Collaborators: name: Bionag SAPI de CV
name: General Hospital Tijuana
First posted: 2021-05-20
Enrollment: 231
Sex: ALL
Minimum age (years): 20
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of SARS-CoV-2 infection in the experimental group.
timeFrame: 9 weeks
measure: Incidence of SARS-CoV-2 infection in the control group.
timeFrame: 9 weeks
Secondary outcomes:
measure: Number of participants with adverse reactions by AgNPs.
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Tijuana General Hospital
state: Baja California
Study officials:
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