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

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04931004

Collaborator

Colgate Palmolive (Industry), University of Leicester (Other)

Enrollment

Arms

7.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Mouthwash Product Other: Water rinse	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants will be randomized to one of four arms. Type of mouthwash will not be disclosed to participant. Laboratory personnel and investigators performing the outcome measurements and analysis will be blinded to intervention.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation Phase - Secondary Endpoint [Single timepoint, ~1 hour]
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
Comparative Saliva Reduction [Single timepoint, ~1.5 hours]
Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.

Other Outcome Measures

Influence of Speaking [Single timepoint, ~1 hour]
Difference in viral load by face mask sampling with speaking versus not speaking

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rutgers, The State University of New Jersey
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yingda Linda Xie, MD, Assistant Professor, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT04931004

Other Study ID Numbers:

Pro2020003236

First Posted:

Jun 18, 2021

Last Update Posted:

Jun 23, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jun 23, 2021