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
About this trial
This is an interventional prevention trial for Covid19
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
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
NCT ID
NCT04931004
First Posted
June 16, 2021
Last Updated
June 17, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Colgate Palmolive, University of Leicester
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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