Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19)

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

In this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5 groups: distilled water, CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine Zero (Johnson and Johnson, USA).

Study participants will be asked to rinse/gargle with 10-20ml (according to the rinse instructions) of the assigned solutions 4 times per day, for 30-60 seconds, for 4 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Rowpar Pharmaceuticals, Inc.
• Treatments: Cetylpyridinium; Chlorine dioxide; Hydrogen Peroxide; Listerine

Criteria

Inclusion Criteria:

• Tested positive for COVID-19 with a sample collected in the prior 7 days

• Ability to read and speak English or Spanish

• Ability to participate in the study for 4 weeks

• Being asymptomatic or having mild or moderate symptoms (for example, sore throat, coughing, fever, fatigue)

• Ability to rinse/gargle

• Not having any condition that might worsen with gargling solutions

• Not having a history of mouthwash sensitivity

• Not having an allergy to any mouthwash that has been used before

• Not using another mouthwash/gargling solution since the most recent positive test

• Not taking antimicrobial medications (antibacterial, antiviral, antibiotics including off-label FDA-approved medications such as hydroxychloroquine)

• Anticipated ability to participate in the study for 4 weeks

• Have a cellphone and agree to receive text messages for reminders to use mouthwash during the day and for follow-up visits, and can videoconference (like zoom) on a cellphone, tablet, or computer for sample collection instructions

Exclusion Criteria:

• People who because of their symptoms intend to receive antiviral medications that could potentially affect viral load in their saliva samples

• Pregnant or lactating women due to potential aversions to mouthwash solution taste/smell.