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

NCT04931004 | Completed Early Phase 1 FDA Drug

• 1 other identifier: Pro2020003236
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Evaluation Phase - Secondary Endpoint

  Single timepoint, ~1 hour

• Comparative Saliva Reduction

  Single timepoint, ~1.5 hours

Other Outcomes (1)

• Influence of Speaking

  Single timepoint, ~1 hour

Study Arms (1)

0.075% Cetylpyridinium Chloride

EXPERIMENTAL

Crossover design where a series of viral load measurements are taken before and after water rinse (placebo) and repeated before and after CPC rinse (intervention). The order of the rinses were randomized after the 19th participant.

Drug: Mouthwash Product

Interventions

Mouthwash Product DRUG

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. Additionally viral load measured prior to and after water rinse using serial face mask and saliva samples. These serial measurements and both CPC and water rinses were conducted consecutively in one visit.

Also known as: water rinse

0.075% Cetylpyridinium Chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Colgate Palmolive: collaborator
• University of Leicester: collaborator

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yingda L Xie, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

• David Alland, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

• Padmapriya Banada, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Face mask and saliva SARS-CoV-2 viral RNA loads are measured before and after water rinse and before and after mouthwash rinse (intervention). Order is randomized. Participant is not told which rinse they are using, though can likely differentiate by taste.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 18, 2021
• Study Start: July 21, 2021
• Primary Completion: May 24, 2022
• Study Completion: December 31, 2022
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)