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

Covid19 Clinical Trial

Official title:

Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04931004
• Other study ID #: Pro2020003236
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2021
• Est. completion date: February 2022

Study information

• Verified date: June 2021
• Source: Rutgers, The State University of New Jersey
• Contact: Yingda L Xie, MD
• Phone: 9739722246
• Email: yingda.xie[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: February 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Mouthwash Product
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.

Other:
• Water rinse
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Colgate Palmolive, University of Leicester

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Influence of Speaking	Difference in viral load by face mask sampling with speaking versus not speaking	Single timepoint, ~1 hour
Primary	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
Primary	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
Secondary	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
Secondary	Comparative Saliva Reduction	Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.	Single timepoint, ~1.5 hours