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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409873
Recruitment Status : Completed
First Posted : June 1, 2020
Last Update Posted : September 30, 2022
Sponsor:
Collaborator:
Rowpar Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE May 28, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date September 30, 2022
Actual Study Start Date  ICMJE March 31, 2021
Actual Primary Completion Date September 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
Change in SARS-Cov-2 viral load [ Time Frame: Baseline to 4 weeks ]
Change in saliva wash RT-PCR SARS-Cov-2 viral load
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • Change in self-reported clinical symptom onset [ Time Frame: Baseline to 4 weeks ]
    Change in self-reported (questionnaire) clinical symptom onset. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.
  • Change in healthcare utilization and hospitalization [ Time Frame: Baseline to 4 weeks ]
    Change in healthcare utilization and hospitalization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2020)
  • Change in SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers [ Time Frame: Baseline to 4 weeks ]
    Change in saliva wash RT-PCR SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers
  • Change in self-reported clinical symptom onset in tobacco users, marijuana smokers, or vapers [ Time Frame: Baseline to 4 weeks ]
    Change in self-reported (questionnaire) clinical symptom onset in tobacco users, marijuana smokers, or vapers. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.
  • Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers [ Time Frame: Baseline to 4 weeks ]
    Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19)
Official Title  ICMJE Effect of Antiseptic Mouthwash/Gargling Solutions and Pre-procedural Rinse on SARS-CoV-2 Load (COVID-19)
Brief 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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.

Primary Purpose: Supportive Care
Condition  ICMJE
  • COVID-19
  • SARS-CoV 2
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Virus Disease
  • Coronavirus Infections
  • Pharyngeal Diseases
Intervention  ICMJE
  • Drug: Oral-B Mouth Sore mouthwash
    Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
    Other Names:
    • hydrogen peroxide
    • H2O2
  • Drug: Crest Pro-Health Multi-Protection mouthwash
    Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
    Other Names:
    • cetylpyridinium chloride
    • C21H38ClN
  • Drug: CloSYS Ultra Sensitive Rinse mouthwash
    Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.
    Other Names:
    • chlorine dioxide
    • ClO2
  • Drug: Distilled water
    Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
    Other Names:
    • water
    • H2O
  • Drug: Listerine Zero Mouthwash Product
    Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
    Other Name: alcohol-free
Study Arms  ICMJE
  • Placebo Comparator: Control (Distilled Water)
    Over the counter: Distilled water
    Intervention: Drug: Distilled water
  • Experimental: Oral-B Mouth Sore (H2O2) mouthwash
    Over the counter: Oral-B Mouth Sore (Oral-B, USA) contains hydrogen peroxide (H2O2)
    Intervention: Drug: Oral-B Mouth Sore mouthwash
  • Experimental: Crest Pro-Health Multi-Protection (C21H38ClN) mouthwash
    Over the counter: Crest Pro-Health Multi-Protection (Crest, USA) contains cetylpyridinium chloride (C21H38ClN)
    Intervention: Drug: Crest Pro-Health Multi-Protection mouthwash
  • Experimental: CloSYS (ClO2) mouthwash
    Over the counter: CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA) contains stabilized chlorine dioxide (ClO2)
    Intervention: Drug: CloSYS Ultra Sensitive Rinse mouthwash
  • Experimental: Listerine Mouthwash
    Over the counter: Listerine Zero (Alcohol-Free)(Johnson and Johnson, USA) (C30H52O3)
    Intervention: Drug: Listerine Zero Mouthwash Product
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2022)
54
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2020)
120
Actual Study Completion Date  ICMJE September 10, 2022
Actual Primary Completion Date September 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04409873
Other Study ID Numbers  ICMJE 20-30874
R00RG2901 ( Other Grant/Funding Number: UCOP Emergency COVID19 Rsrch Fd: Cal Breast Cancer Rsrch Pgm )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of California, San Francisco
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Rowpar Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Stuart A Gansky, DrPH Professor and Lee Hysan Chair of Oral Epidemiology
PRS Account University of California, San Francisco
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP