Evaluation of the Efficacy of Mouth Rinses With Commercial Mouthwashes to Decrease Viral Load in Saliva in COVID-19 Patients
1 other identifier
interventional
48
1 country
4
Brief Summary
As no curative treatment for SARS-CoV-2 is currently available, most public health measures to contain the pandemic are based on preventing the spread of the pathogen. The virus is transmitted by the respiratory route and by direct contact with contaminated surfaces and subsequent contact with nasal, oral or ocular mucosa. Although patients with symptomatic coronavirus disease 2019 (COVID-19) have been the main source of transmission, observations suggest that asymptomatic and incubating patients also have the ability to transmit SARS-CoV-2. Angiotensin II converting enzyme (ACE2) is the main cellular receptor for SARS-CoV-2, which interacts with the spike protein to facilitate its entry. ACE2 receptors are highly expressed in the oral cavity and present at high levels in oral epithelial cells. The mean expression of ACE2 was higher in the tongue compared to that in other oral tissues and it has been found to be higher in the minor salivary glands than in the lungs. These findings strongly suggest that the oral cavity and specifically the saliva may be a high-risk route for SARS-CoV-2 infection. Thus, strategies reducing salivary viral load could contribute to reduce the risk of transmission. Furthermore, studies using macaques as animal models have shown that SARS-CoV persists for two days in oral mucous membranes before its diffusion to the lower respiratory tract. This offers an interesting preventive and therapeutic window of opportunity for the control of this disease. For this reason, the use of mouthwashes with antiseptics that have virucidal activity can be a simple preventive strategy that could easily be applied both by infected patients before being examined by sanitary personnel and in the general population. This study is a multi-centered, blinded, parallel-group, placebo-controlled randomised clinical trial that tests the effect of three different mouthwashes (chlorhexidine 0,12%, chlorhexidine 0,2%, and Cymenol -ZnCl2) in the salivary viral load of SARS-CoV-2 measured by qPCR at three different timepoints. A fourth group of patients using a distilled water mouth rinse is used as a control. Viral particles per ml of saliva are quantified at baseline and 5, 15 and 60 minutes after a 1-minute mouth rinse with the antiseptic or water. The study aims to test whether any of these standard oral antiseptics appear to diminish viral load in saliva and could therefore be used as a strategy to reduce transmission risk in clinical and social settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Apr 2021
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2022
CompletedFirst Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 16, 2022
CompletedSeptember 16, 2022
September 1, 2022
9 months
September 12, 2022
September 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effect of the four different mouthwashes on the change of SARS-Cov2 viral load in saliva
Determine the changes on the SARS-Cov2 viral load in saliva tested in vivo by RT-qPCR, between baseline values and those obtained at 5 minutes, at 15 minutes and at 60 minutes, after the use of four different mouthwashes randomized on 40 COVID-19 patients.
Minute 0 (before mouthwash) - Minute 5 (after mouthwash) - Minute 15 (after mouthwash) - Minute 60 (after mouthwash)
Effect of 4 different mouthwashes on the change of infective SARS-Cov2 viral load in saliva
Determine the changes on the SARS-Cov2 infective viral load in saliva tested in vivo by cell culture, between baseline values and those obtained at 5 minutes, at 15 minutes and at 60 minutes after the use of 4 different mouthwashes randomized on 40 COVID-19 patients.
Minute 0 (before mouthwash) - Minute 5 (after mouthwash) - Minute 15 (after mouthwash) - Minute 60 (after mouthwash)
Study Arms (4)
Chlorhexidine 0,12%
EXPERIMENTAL15 ml 0,12% Chlorhexidine, one minute rinse.
Chlorhexidine 0,20%
EXPERIMENTAL15 ml 0,20% Chlorhexidine, one minute rinse.
Gingilacer Encias Delicadas
EXPERIMENTAL15 ml 0,10% cymenol + 0,10% zinc chloride, one minute rinse.
Distilled Water
PLACEBO COMPARATOR15 ml Distilled Water, one minute rinse.
Interventions
15 ml 0,12% Chlorhexidine, one minute rinse
15 ml 0,2% Chlorhexidine, one minute rinse
15 ml 0,10% cymenol + 0,10% zinc chloride, one minute rinse
Eligibility Criteria
You may qualify if:
- Lower than 7 days from the positive SARS-COV-2 PCR test of a nasopharyngeal sample
- Have the ability to donate saliva samples and perform mouthwash
You may not qualify if:
- Patient participation in a COVID-19 research study using experimental drugs,
- Use of an antiseptic mouthwash for 48 h before the start of the study
- Any known hypersensitivity or allergy to components of the mouthwashes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario General de Villalba
Madrid, Spain
Hospital Universitario Infanta Elena
Madrid, Spain
Fundación para el Fomento de la Investigación Sanitaria y Biiomédica de a Comunitat Valenciana
Valencia, 46020, Spain
Related Publications (2)
Sanchez Barrueco A, Mateos-Moreno MV, Martinez-Beneyto Y, Garcia-Vazquez E, Campos Gonzalez A, Zapardiel Ferrero J, Bogoya Castano A, Alcala Rueda I, Villacampa Auba JM, Cenjor Espanol C, Moreno-Parrado L, Ausina-Marquez V, Garcia-Esteban S, Artacho A, Lopez-Labrador FX, Mira A, Ferrer MD. Effect of oral antiseptics in reducing SARS-CoV-2 infectivity: evidence from a randomized double-blind clinical trial. Emerg Microbes Infect. 2022 Dec;11(1):1833-1842. doi: 10.1080/22221751.2022.2098059.
PMID: 35796097BACKGROUNDFerrer MD, Barrueco AS, Martinez-Beneyto Y, Mateos-Moreno MV, Ausina-Marquez V, Garcia-Vazquez E, Puche-Torres M, Giner MJF, Gonzalez AC, Coello JMS, Rueda IA, Auba JMV, Espanol CC, Velasco AL, Abad DS, Garcia-Esteban S, Artacho A, Lopez-Labrador X, Mira A. Clinical evaluation of antiseptic mouth rinses to reduce salivary load of SARS-CoV-2. Sci Rep. 2021 Dec 22;11(1):24392. doi: 10.1038/s41598-021-03461-y.
PMID: 34937855BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alejandro Mira, PhD
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The hospital staff consecutively assigned each participant a code following the order from a previously randomly generated table. The code were unknown to the personnel who processed the samples and to those that analyzed the data. Participants were blinded by using identical tubes with the same volume for both mouthwashes and placebo.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief investigator of the Oral Microbiome Lab
Study Record Dates
First Submitted
September 12, 2022
First Posted
September 16, 2022
Study Start
April 13, 2021
Primary Completion
January 8, 2022
Study Completion
January 8, 2022
Last Updated
September 16, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share