Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection

Study Overview
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Brief Summary
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Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.

Detailed Description
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The study will consist of a Control Phase to optimize procedures for measuring expelled/exhaled viral load, and a Evaluation phase comparing different commercially available mouthwashes. In the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash. Based on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.

Official Title
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Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2

Conditions
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Covid19

Intervention / Treatment
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* Drug: Mouthwash Product
* Other: Water rinse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Able to provide consent Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours. Exclusion Criteria: Clinical contraindication or poor feasibility to complete study procedures Unwilling or unable to produce saliva or face mask samples Unable to produce at least 500 microliters of saliva. Eaten within past 30 minutes Known allergy to mouthwash products

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.075% Cetylpyridinium Chloride<br> | Drug: Mouthwash Product<br>* Commercially over-the-counter Colgate mouthwashes will be administered according to standard package instructions. Viral load will be measured prior to and after mouth rinse using serial face mask and saliva samples.<br>|
| Experimental: 1.5% Hydrogen peroxide<br> | Drug: Mouthwash Product<br>* Commercially over-the-counter Colgate mouthwashes will be administered according to standard package instructions. Viral load will be measured prior to and after mouth rinse using serial face mask and saliva samples.<br>|
| Experimental: Chlorhexidine gluconate<br> | Drug: Mouthwash Product<br>* Commercially over-the-counter Colgate mouthwashes will be administered according to standard package instructions. Viral load will be measured prior to and after mouth rinse using serial face mask and saliva samples.<br>|
| Placebo Comparator: Water rinse<br>Control for impact on viral load changes from mechanical rinsing | Other: Water rinse<br>* 30-second water rinse will occur in the control group. Viral load will be measured prior to and after water rinse using serial face mask and saliva samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control Phase - Primary Endpoint | Reduction in viral load by face mask sampling from pre-intervention to 0-15 with CPC versus water rinse control | Single timepoint,  1 hour | 
| Evaluation Phase - Primary Endpoint | Reduction in viral load by face mask sampling from pre-intervention to 45-60 minutes versus water rinse control | Single timepoint,  1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation Phase - Secondary Endpoint | Reduction in viral load by face mask sampling from pre-intervention to 0-15 and15-30 minutes of oral rinse products versus water rinse control | Single timepoint,  1 hour | 
| Comparative Saliva Reduction | Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention. | Single timepoint,  1.5 hours |