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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: Mouthwash Product; Other: Water rinse

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yingda L Xie, MD; Phone Number: 9739722246; Email: yingda.xie@rutgers.edu
• Study Contact Backup: Name: David Alland, MD; Email: allandda@njms.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18
2. Able to provide consent
3. Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours.

Exclusion Criteria:

1. Clinical contraindication or poor feasibility to complete study procedures
2. Unwilling or unable to produce saliva or face mask samples
3. Unable to produce at least 500 microliters of saliva.
4. Eaten within past 30 minutes
5. Known allergy to mouthwash products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.075% Cetylpyridinium Chloride	Drug: Mouthwash Product; 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.
Experimental: 1.5% Hydrogen peroxide	Drug: Mouthwash Product; 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.
Experimental: Chlorhexidine gluconate	Drug: Mouthwash Product; 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.
Placebo Comparator: Water rinse; Control for impact on viral load changes from mechanical rinsing	Other: Water rinse; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of Speaking	Difference in viral load by face mask sampling with speaking versus not speaking	Single timepoint, ~1 hour

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Colgate Palmolive; University of Leicester
• Investigators: Principal Investigator: Yingda L Xie, MD, Rutgers University; Principal Investigator: David Alland, MD, Rutgers University; Principal Investigator: Padmapriya Banada, PhD, Rutgers University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro2020003236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes