Covid19Early Phase 1NCT04931004
Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection
A Early Phase 1 study testing Mouthwash Product in people with Covid19, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Mouthwash Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 31 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Able to provide consent
- Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2
Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.
Read the 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.
- Conditions
- Covid19
- Being tested
- Mouthwash Product
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthwash ProductDrug
Also called water rinse
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Mouthwash Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control Phase - Primary Endpoint
Reduction in viral load by face mask sampling from pre-intervention to 0-15 with CPC versus water rinse control
Measured: 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
Measured: Single timepoint, ~1.5 hours
Secondary outcomes (2)
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
Measured: Single timepoint, ~1 hour
Comparative Saliva Reduction
Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.
Measured: Single timepoint, ~1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start21 Jul 2021
- Primary completion24 May 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive, University of Leicester
- Responsible party
- Principal investigator, Yingda L Xie, Rutgers, The State University of New Jersey
- Investigators
- Yingda L Xie, MD, Principal investigator, Rutgers UniversityDavid Alland, MD, Principal investigator, Rutgers UniversityPadmapriya Banada, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931004
- Sponsor's protocol ID
- Pro2020003236
- Status last verified
- Jan 2026
- First submitted
- 16 Jun 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04931004
- Acronym / sponsor ID
- Pro2020003236
- Conditions
- Covid19
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Colgate Palmolive, University of Leicester
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.075% Cetylpyridinium Chloride | Experimental | Drug: Mouthwash ProductCrossover 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- Able to provide consent
- Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouthwash ProductAlso: water rinseCommercially 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. | Drug | 0.075% Cetylpyridinium Chloride |
Primary outcome
Control Phase - Primary Endpoint
Time frame: 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
Time frame: Single timepoint, ~1.5 hours
Reduction in viral load by face mask sampling from pre-intervention to 45-60 minutes versus water rinse control
2 secondary outcomes
Evaluation Phase - Secondary Endpoint
Time frame: Single timepoint, ~1 hour
Comparative Saliva Reduction
Time frame: Single timepoint, ~1.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingda L Xie, MD principal investigator
Rutgers University
David Alland, MD principal investigator
Rutgers University
Padmapriya Banada, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mouthwash Product in people with Covid19, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control Phase - Primary Endpoint (time frame: Single timepoint, ~1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.