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

Primary Purpose

Covid19

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Mouthwash Product
Water rinse
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    0.075% Cetylpyridinium Chloride

    1.5% Hydrogen peroxide

    Chlorhexidine gluconate

    Water rinse

    Arm Description

    Control for impact on viral load changes from mechanical rinsing

    Outcomes

    Primary Outcome Measures

    Control Phase - Primary Endpoint
    Reduction in viral load by face mask sampling from pre-intervention to 0-15 with CPC versus water rinse control
    Evaluation Phase - Primary Endpoint
    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
    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
    Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.

    Full Information

    First Posted
    June 16, 2021
    Last Updated
    June 17, 2021
    Sponsor
    Rutgers, The State University of New Jersey
    Collaborators
    Colgate Palmolive, University of Leicester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04931004
    Brief Title
    Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection
    Official Title
    Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rutgers, The State University of New Jersey
    Collaborators
    Colgate Palmolive, University of Leicester

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid19

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    0.075% Cetylpyridinium Chloride
    Arm Type
    Experimental
    Arm Title
    1.5% Hydrogen peroxide
    Arm Type
    Experimental
    Arm Title
    Chlorhexidine gluconate
    Arm Type
    Experimental
    Arm Title
    Water rinse
    Arm Type
    Placebo Comparator
    Arm Description
    Control for impact on viral load changes from mechanical rinsing
    Intervention Type
    Drug
    Intervention Name(s)
    Mouthwash Product
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Water rinse
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Control Phase - Primary Endpoint
    Description
    Reduction in viral load by face mask sampling from pre-intervention to 0-15 with CPC versus water rinse control
    Time Frame
    Single timepoint, ~1 hour
    Title
    Evaluation Phase - Primary Endpoint
    Description
    Reduction in viral load by face mask sampling from pre-intervention to 45-60 minutes versus water rinse control
    Time Frame
    Single timepoint, ~1.5 hours
    Secondary Outcome Measure Information:
    Title
    Evaluation Phase - Secondary Endpoint
    Description
    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
    Time Frame
    Single timepoint, ~1 hour
    Title
    Comparative Saliva Reduction
    Description
    Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.
    Time Frame
    Single timepoint, ~1.5 hours
    Other Pre-specified Outcome Measures:
    Title
    Influence of Speaking
    Description
    Difference in viral load by face mask sampling with speaking versus not speaking
    Time Frame
    Single timepoint, ~1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yingda L Xie, MD
    Phone
    9739722246
    Email
    yingda.xie@rutgers.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Alland, MD
    Email
    allandda@njms.rutgers.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yingda L Xie, MD
    Organizational Affiliation
    Rutgers University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    David Alland, MD
    Organizational Affiliation
    Rutgers University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Padmapriya Banada, PhD
    Organizational Affiliation
    Rutgers University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

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

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