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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||231 participants|
|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)|
|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|
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
- 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.
- 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.
- 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.
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
|Tijuana General Hospital|
|Tijuana, Baja California, Mexico, 22310|