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

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ClinicalTrials.gov Identifier: NCT04409873
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
Rowpar Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Severe Acute Respiratory Syndrome Coronavirus 2 Virus Disease Coronavirus Infections Pharyngeal Diseases Drug: Oral-B Mouth Sore mouthwash Drug: Crest Pro-Health Multi-Protection mouthwash Drug: CloSYS Ultra Sensitive Rinse mouthwash Drug: Distilled water Drug: Listerine Zero Mouthwash Product Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
Official Title: Effect of Antiseptic Mouthwash/Gargling Solutions and Pre-procedural Rinse on SARS-CoV-2 Load (COVID-19)
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: alcohol-free




Primary Outcome Measures :
  1. Change in SARS-Cov-2 viral load [ Time Frame: Baseline to 4 weeks ]
    Change in saliva wash RT-PCR SARS-Cov-2 viral load


Secondary Outcome Measures :
  1. 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.

  2. Change in healthcare utilization and hospitalization [ Time Frame: Baseline to 4 weeks ]
    Change in healthcare utilization and hospitalization


Other Outcome Measures:
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409873


Contacts
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Contact: Stuart A Gansky, DrPH 415-502-8094 stuart.gansky@ucsf.edu
Contact: Sepideh Banava, DDS, MPH 415-855-1077 sepideh.banava@ucsf.edu

Locations
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United States, California
University Of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Stuart A Gansky, DrPH    415-502-8094    stuart.gansky@ucsf.edu   
Contact: Sepideh Banava, DDS, MPH    415-855-1077    sepideh.banava@ucsf.edu   
Principal Investigator: Stuart A Gansky, DrPH         
Sub-Investigator: Sepideh Banava, DDS, MPH         
Sponsors and Collaborators
University of California, San Francisco
Rowpar Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Stuart A Gansky, DrPH Professor and Lee Hysan Chair of Oral Epidemiology
Additional Information:
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04409873    
Other Study ID Numbers: 20-30874
R00RG2901 ( Other Grant/Funding Number: UCOP Emergency COVID19 Rsrch Fd: Cal Breast Cancer Rsrch Pgm )
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, San Francisco:
Anti-Infective Agents, Local
Mouthwashes
Gargle
Saliva
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Pharyngeal Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Hydrogen Peroxide
Listerine
Cetylpyridinium
Chlorine dioxide
Anti-Infective Agents, Local
Anti-Infective Agents
Dental Disinfectants
Disinfectants