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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
None (Open Label)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
0.075% Cetylpyridinium Chloride 		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
    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.
    Other names:
    • water rinse

Recruiting Locations

More Details

NCT ID
NCT04931004
Status
Completed
Sponsor
Rutgers, The State University of New Jersey

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.