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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A blinded randomized controlled parallel group design trial
Primary Purpose
Supportive Care
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.

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Control (Distilled Water) 		Over the counter: Distilled water
  • Drug: Distilled water
    Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
    Other names:
    • water
    • H2O
Experimental
Oral-B Mouth Sore (H2O2) mouthwash 		Over the counter: Oral-B Mouth Sore (Oral-B, USA) contains hydrogen peroxide (H2O2)
  • Drug: Oral-B Mouth Sore mouthwash
    Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
    Other names:
    • hydrogen peroxide
    • H2O2
Experimental
Crest Pro-Health Multi-Protection (C21H38ClN) mouthwash 		Over the counter: Crest Pro-Health Multi-Protection (Crest, USA) contains cetylpyridinium chloride (C21H38ClN)
  • Drug: Crest Pro-Health Multi-Protection mouthwash
    Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
    Other names:
    • cetylpyridinium chloride
    • C21H38ClN
Experimental
CloSYS (ClO2) mouthwash 		Over the counter: CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA) contains stabilized chlorine dioxide (ClO2)
  • Drug: CloSYS Ultra Sensitive Rinse mouthwash
    Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.
    Other names:
    • chlorine dioxide
    • ClO2
Experimental
Listerine Mouthwash 		Over the counter: Listerine Zero (Alcohol-Free)(Johnson and Johnson, USA) (C30H52O3)
  • Drug: Listerine Zero Mouthwash Product
    Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
    Other names:
    • alcohol-free

Recruiting Locations

More Details

NCT ID
NCT04409873
Status
Terminated
Sponsor
University of California, San Francisco

Detailed Description

SARS-CoV-2, the virus causing COVID-19, has affected vulnerable individuals, especially those with comorbidities, and high exposure health care workers (HCWs). Typically, the virus first colonizes in the upper respiratory tract (URT) causing clinical symptoms such as coughing, sore throat, and then is transferred to the lower respiratory tract (LRT) which can lead to severe pneumonia, acute respiratory distress syndrome (ARDS), sepsis, and death, if it is not managed. The World Health Organization (WHO) has presented comprehensive guidelines underscoring personal hygiene measures including respiratory hygiene against SARS, MERS, influenza, and now SARS-CoV-2 / COVID-19. While personal protection equipment (PPE), personal hygiene measures, environmental infection control, and physical distancing are crucial in mitigating disease transmission, respiratory hygiene measures do not prevent SARS-CoV-2 colonization in URTs and LRTs of infected individuals (symptomatic and asymptomatic). Experimental and clinical research studies on infections similar to COVID-19 such as SARS, MERS, and H5N1 have shown that using antiseptic mouthwash/gargling solutions, such as products containing chlorhexidine gluconate (CHG), polyvinylpyrrolidone iodine (PVP-I), chlorine dioxide (ClO2), cetylpyridinium chloride (CPC), and hydrogen peroxide (H2O2) can reduce viral load. A randomized controlled trial (N=387) showed efficacy and cost-effectiveness of gargling with water or a product containing PVP-I (3X/day, 20 seconds) on URTIs in healthy volunteers (18-65 years) over 60 days from a societal perspective; in vitro studies have shown that CloSYS, an over the counter mouthwash containing ClO2, was effective on inactivating SARS-CoV as well as disinfecting dental unit waterlines, and biofilm control in ultrasonic dental scaling units. A recent study has shown that CloSYS Ultra Sensitive Oral Rinse reduced the viral load of SARS CoV 2, SARS CoV, and Influenza A H3N2 to a varying extent. The data show that the viral load reduction of SARS CoV 2 by Ultra Sensitive rinse was 10 fold more than the reduction of SARS CoV in 30s. Recently, the US Centers for Disease Control (CDC) and the American Dental Association (ADA) have recommended using a mouthwash containing 1.0-1.5% H2O2 as a pre-procedural rinse before dental treatment to potentially reduce SARS-CoV-2 load; however, no in vivo clinical studies have been conducted to support this claim. The aim of this pilot trial is to evaluate the effect of four over-the-counter antiseptic mouthwash/gargling solutions compared to a control (distilled water) to reduce SARS-CoV-2 load. In addition, study participants will be assessed for the severity of their clinical symptoms during the study period. The 4-week protocol was selected as studies have shown that patients can continue to shed the virus and potentially transmit it to the others for a 2 to 4 week period. An interim analysis is planned when 10 participants per arm (50 total) complete the study using the alpha-spending function with O'Brien-Fleming boundary rule.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.