Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Stuart A Gansky, DrPH (ucsf)
Photo of Stuart A Gansky
Stuart A Gansky

Description

Summary

In this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5 groups: distilled water, CloSYS (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine (Johnson and Johnson, USA). Study participants will be asked to rinse/gargle with 10ml (2 teaspoons) of the assigned solutions 4 times per day, for 30 seconds, for 4 weeks.

Official Title

Effect of Antiseptic Mouthwash/Gargling Solutions and Pre-procedural Rinse on SARS-CoV-2 Load (COVID-19)

Details

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 infected surfaces, dental unit waterlines, and biofilms in ultrasonic dental scaling units. 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 three 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 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.

Keywords

COVID-19 SARS-CoV 2 Severe Acute Respiratory Syndrome Coronavirus 2 Virus Disease Coronavirus Infections Pharyngeal Diseases Anti-Infective Agents, Local Mouthwashes Gargle Saliva Virus Diseases Severe Acute Respiratory Syndrome Hydrogen Peroxide Listerine Cetylpyridinium Chlorine dioxide Oral-B Mouth Sore mouthwash Crest Pro-Health Multi-Protection mouthwash CloSYS mouthwash Distilled water Listerine Mouthwash Product Oral-B Mouth Sore (H2O2) mouthwash Crest Pro-Health Multi-Protection (C21H38ClN) mouthwash CloSYS (ClO2) mouthwash Listerine Mouthwash

Eligibility

You can join if…

Open to people ages 18 years and up

  • Tested positive for COVID-19 in prior 7 days
  • Ability to read and speak in English
  • Ability to participate in the study for 4 weeks
  • Ability to gargle
  • Not having any condition that might worsen with gargling solutions
  • Not having an allergy to a study mouthwash ingredient
  • Not using another mouthwash/gargling solution
  • 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

You CAN'T join if...

  • 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.

Location

  • University Of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UC Health

  • Stuart A Gansky, DrPH (ucsf)
    I am Professor and Lee Hysan Chair of Oral Epidemiology in the School of Dentistry and Director (PI) of NIH-funded UCSF Center to Address Disparities in Children's Oral Health (CAN-DO). Previously, for more than 4 years, I was Director of the Data Coordinating Center for NIH-funded Early Childhood Caries Collaborative Centers at UCSF, University of Colorado Denver, and Boston University.