COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses

Study Overview
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Brief Summary
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Given the current lack of effective COVID-19 treatment, it is necessary to explore alternative methods to contain the spread of the infection, focusing in particular on its mode of transmission. The modes of person-to-person transmission of SARS-CoV-2 are direct transmission, such as sneezing, coughing, transmission through inhalation of small droplets, and transmission through contact, such as contact with nasal, oral and eye mucous membranes. SARS-CoV-2 can also be transmitted directly or indirectly through saliva. The use of antiviral mouthrinses may be used as adjunctive therapy.

Official Title
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COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses: Double-blind, Randomized, Placebo-controlled Clinical Study

Conditions
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COVID19, Mouthwash, Saliva

Intervention / Treatment
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* Device: mouthrinse with bêta-cyclodextrin and citrox
* Device: mouthrinse without bêta-cyclodextrin and citrox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Covid-19 infection by the patient's general practitioner and hospital doctor Clinical signs started less than 8 days ago. Virological confirmation Understanding and acceptance of the trial. Written agreement to participate in the trial Exclusion Criteria: Pregnancy Breastfeeding Inability to comply with protocol Lack of written agreement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mouth rinse with antiviral<br> | Device: mouthrinse with bêta-cyclodextrin and citrox<br>* 3 daily mouthrinses for 7 days<br>|
| Placebo Comparator: mouth rinse without antiviral<br> | Device: mouthrinse without bêta-cyclodextrin and citrox<br>* 3 daily mouthrinses for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days | Quantitative PCR experiments will be performed and a quantitative analysis of the salivary samples will be made | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days | Quantitative PCR experiments will be performed and a quantitative analysis of the nasal samples will be made | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19, SARS-CoV-2, mouthrinses, antiviral, bêta-cyclodextrin, citrox