Covid19
Conditions
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.
Interventions
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.
Sponsors
Rutgers, The State University of New Jersey
Colgate Palmolive
University of Leicester
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Control Phase - Primary Endpoint | 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 | Single timepoint, ~1.5 hours | Reduction in viral load by face mask sampling from pre-intervention to 45-60 minutes versus water rinse control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation Phase - Secondary Endpoint | Single timepoint, ~1 hour | 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 | Single timepoint, ~1.5 hours | Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYingda L Xie, MD
Rutgers University
PRINCIPAL_INVESTIGATORDavid Alland, MD
Rutgers University
PRINCIPAL_INVESTIGATORPadmapriya Banada, PhD
Rutgers University
Outcome results
None listed