Antiseptic Mouth Rinses to Reduce Salivary Viral Load in COVID-19 Patients
Status:
Completed
Trial end date:
2021-09-30
Target enrollment:
Participant gender:
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 four
different mouthwashes (CPC, chlorhexidine, povidone-iodine and H2O2) in the salivary viral
load of SARS-CoV-2 measured by qPCR at three different timepoints. A fifth 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 30, 60 and 120 minutes after a 1-minute mouth rinse with the
antiseptic or water. Our 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.
Phase:
N/A
Details
Lead Sponsor:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Collaborators:
Dentaid SL Hospital Clínico Universitario de Valencia Hospital Universitario Fundación Jiménez Díaz Hospital Universitario General de Villalba Hospital Universitario Infanta Elena Hospital Universitario Virgen de la Arrixaca