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| Name | Class |
|---|---|
| Colgate Palmolive | INDUSTRY |
| University of Leicester | OTHER |
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Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Single timepoint, ~1 hour |
| Comparative Saliva Reduction |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of Speaking | Difference in viral load by face mask sampling with speaking versus not speaking | Single timepoint, ~1 hour |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingda L Xie, MD | Rutgers University | Principal Investigator |
| David Alland, MD | Rutgers University | Principal Investigator |
| Padmapriya Banada, PhD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Newark | New Jersey | 07103 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Beginning 3 months and ending 5 years following article publication
Researchers who provide a methodologically sound proposal
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2021 | Aug 18, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.
| Single timepoint, ~1.5 hours |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |