Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19)
Condition: COVID-19; SARS-CoV 2; Severe Acute Respiratory Syndrome Coronavirus 2; Virus Disease; Coronavirus Infections; Pharyngeal Diseases
MeSH terms: COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome; Virus Diseases; Pharyngeal Diseases
Intervention: Oral-B Mouth Sore mouthwash; Crest Pro-Health Multi-Protection mouthwash; CloSYS Ultra Sensitive Rinse mouthwash; Distilled water; Listerine Zero Mouthwash Product
Intervention description: Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.; Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.; Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.; Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.; Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
Intervention MeSH terms: Hydrogen Peroxide; Listerine; Cetylpyridinium; Chlorine dioxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A blinded randomized controlled parallel group design trial
Masking: Double (Participant, Outcomes Assessor)
Masking description: Study participants will be blinded to the solutions to the extent possible (i.e., similar packages with identification number bar codes).
The lab technician who evaluates the SARS-CoV-2 load in samples will be blinded to the solutions and study groups.
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anti-Infective Agents, Local; Mouthwashes; Gargle; Saliva

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.
    

Eligibility 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.