Efficacy of Mouthwashes in Reducing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load in the Saliva

Study Overview
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Brief Summary
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This is a single-blind, parallel-group, randomized pilot study designed to evaluate and compare the efficacy of 3 different mouthwashes containing 0.2% Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride in reducing Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in the saliva of COVID-19 positive patients at different time-points. A convenient sample of up to 40 COVID-19 positive patients diagnosed via test and/or presenting COVID-19 clinical symptoms will be identified in the inpatients and/or outpatient clinics at the Newham University Hospital and at The Royal London Hospital, Barts Health National Health Service (NHS) Trust, United Kingdom (UK). The study will consist of one visit. Unstimulated saliva samples will be collected from all COVID-19 positive patients before and at 30 minutes, 1, 2, and 3 hours after mouth rinsing (Group 1-3 ) or no rinsing (Group 4). Viral load analysis of saliva samples in the different time-points will be then assessed by Reverse Transcription quantitative PCR (RT- qPCR).

Official Title
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Efficacy of Three Antimicrobial Mouthwashes in Reducing SARS-CoV-2 Viral Load in the Saliva of Patients Diagnosed With COVID-19: A Pilot Study

Conditions
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Covid19, Coronavirus

Intervention / Treatment
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* Drug: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate
* Drug: Colgate Peroxyl® -1.5% Hydrogen peroxide
* Other: Oral-B® Gum & Enamel Care -Cetylpyridinium chloride
* Other: No rinsing


Participation Criteria
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Eligibility Criteria
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All of the following criteria must be fulfilled for inclusion: Patients must have willingness to read and sign a copy of Informed Consent Form. Males and females, ≥ 18 years old. COVID-19 positive patients confirmed via any diagnostic test and/or presented with COVID-19 clinical symptoms at point of consent. Exclusion criteria for patients Patients presenting with any of the following will not be included in the trial: Known pre-existing chronic mucosal lesions e.g. lichen planus or other oropharyngeal lesions, reported by patient or recorded in the existing patient' medical notes; Patients currently intubated or not capable of mouth rinse or spit; History of head and neck radiotherapy or chemotherapy; Self-reported xerostomia; Known allergy or hypersensitivity to chlorhexidine digluconate or one of the mouthwashes constituents; Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial; Inability to comply with study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate<br>Participants will be instructed to rinse their mouth with 10 ml of Corsodyl® Alcohol free mouthwash for 1 minute. | Drug: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate<br>* Corsodyl® Alcohol-free is a clear to slightly opalescent oromucosal solution with an odour of peppermint that contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common oral conditions.<br>|
| Experimental: Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide<br>Participants will be instructed to rinse their mouth with 10 ml of Colgate® Peroxyl mouthwash for 1 minute. | Drug: Colgate Peroxyl® -1.5% Hydrogen peroxide<br>* Peroxyl mouthwash is a clear aqua-blue liquid oromucosal solution which 100ml of solution contains 1.5g of Hydrogen peroxide (as 30% Hydrogen Peroxide solution). It is an oral antiseptic cleanser for external use. The principal action is brought about by contact of hydrogen peroxide with peroxidases and catalases present in tissues and saliva, which causes the rapid release of oxygen. This provides mechanical cleansing which flushes out mouth debris and helps in the treatment of oral irritations. This mouthwash is used as a cleanser in the symptomatic relief of minor mouth and gum irritations.<br>|
| Experimental: Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride<br>Participants will be instructed to rinse their mouth with 10 ml of Oral-B® Gum & Enamel Care mouthwashes for 1 minute. | Other: Oral-B® Gum & Enamel Care -Cetylpyridinium chloride<br>* The Oral-B® Gum & Enamel Care mouthwash is an oromucosal solution containing Cetylpyridinium chloride (CPC) and used as an adjunct to oral hygiene.<br>* Other names: Cosmetic product;|
| Experimental: Group 4 (control group; n= up to 10 patients) - No rinsing<br>Patients will be instructed to not rinse their mouth with any solution, not even water. | Other: No rinsing<br>* No rinsing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load changes in the saliva within groups | Viral load changes in the saliva of COVID-19 positive patients assessed by RT-qPCR assays at 30 minutes, 1, 2 and 3 hours after mouth rinsing with a mouthwash containing 0.2 % Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride compared to baseline. | 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the viral load changes in the saliva between groups | Difference in the viral load changes in the saliva of COVID-19 positive patients assessed by RT-qPCR assays, at the different study time-points, between groups 0.2 % Chlorhexidine digluconate, 1.5% Hydroxide peroxide, Cetylpyridinium chloride mouthwash and no rinsing (control). | 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mouthwash, Chlorhexidine digluconate, Hydroxide peroxide, Cetylpyridinium chloride, Viral load, SARS-CoV-2