Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19) (AMPoL)
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| ClinicalTrials.gov Identifier: NCT04409873 |
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Recruitment Status :
Not yet recruiting
First Posted : June 1, 2020
Last Update Posted : November 20, 2020
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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.
| 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 mouthwash Drug: Distilled water Drug: Listerine Mouthwash Product | Phase 2 |
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.
| 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) |
| Estimated Study Start Date : | December 7, 2020 |
| Estimated Primary Completion Date : | June 30, 2021 |
| Estimated Study Completion Date : | November 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Control (Distilled Water)
Over the counter: Distilled water
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Drug: Distilled water
Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
Other Names:
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Experimental: Oral-B Mouth Sore (H2O2) mouthwash
Over the counter: Oral-B Mouth Sore (Oral-B, USA) contains hydrogen peroxide (H2O2)
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Drug: Oral-B Mouth Sore mouthwash
Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
Other Names:
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Experimental: Crest Pro-Health Multi-Protection (C21H38ClN) mouthwash
Over the counter: Crest Pro-Health Multi-Protection (Crest, USA) contains cetylpyridinium chloride (C21H38ClN)
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Drug: Crest Pro-Health Multi-Protection mouthwash
Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
Other Names:
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Experimental: CloSYS (ClO2) mouthwash
Over the counter: CloSYS (Rowpar Pharmaceutical Inc., USA) contains stabilized chlorine dioxide (ClO2)
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Drug: CloSYS mouthwash
Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
Other Names:
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Experimental: Listerine Mouthwash
Over the counter: Listerine (Zero Alcohol)(Johnson and Johnson, USA)
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Drug: Listerine Mouthwash Product
Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
Other Name: Zero alcohol |
- Change in SARS-Cov-2 viral load [ Time Frame: Baseline to 4 weeks ]Change in saliva wash RT-PCR SARS-Cov-2 viral load
- 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
- 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
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Tested positive for COVID-19 in prior 7 days
- Ability to read and speak English or Spanish
- 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
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.
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
| Contact: Stuart A Gansky, DrPH | 415-502-8094 | stuart.gansky@ucsf.edu | |
| Contact: Sepideh Banava, DDS, MPH | 415-855-1077 | sepideh.banava@ucsf.edu |
| United States, California | |
| University Of California, San Francisco | |
| 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 | |
| Principal Investigator: | Stuart A Gansky, DrPH | Professor and Lee Hysan Chair of Oral Epidemiology |
Publications:
| 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: | November 20, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Anti-Infective Agents, Local Mouthwashes Gargle Saliva |
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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 |