Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mouth Rinses for Inactivation of COVID-19 (MOR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584684
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Randomized, double-blind prospective trial to test the efficacy and acceptability of therapeutic, antiseptic mouth rinses to inactivate severe acute respiratory syndrome coronavirus (SARS-CoV-2) in saliva of COVID-19 positive patients aged 18-65 years old. All mouthrinses are commercially available and will be used according to on-label instructions. Patients will be randomized to a mouthrinse and will be asked to give a saliva sample immediately before and after a one minute mouthwash. Saliva samples will be collected from patients at 15 minute intervals thereafter up to an hour (15, 30, 45 and 60 minutes). The samples will be stored and used for real-time reverse transcription polymerase chain reaction (RT-PCR) detection of viral SARS-CoV-2 RNA and viral infectivity assays. Patients will also complete a short-survey on the taste and experience of using the mouthwash. This study involves 480 subject participants and one, 75-90 minute visit.

Condition or disease Intervention/treatment Phase
Covid19 Coronavirus Infection SARS-CoV-2 Infection Drug: 1.5-2% w/v Hydrogen Peroxide Drug: 0.12% Chlorhexidine Gluconate Drug: 21% Ethanol plus essential oils Drug: 1% w/v Povidone-iodide Drug: 0.075% Cetylpyridinium Chloride Other: Saline Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled, double-blind prospective trial to test the efficacy and acceptability of 5 therapeutic, antiseptic mouth rinses to inactivate SARS-CoV-2 virus in saliva of COVID-19 positive patients.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Saline
Subject participants will rinse mouth one time for 60 seconds with 10 mL of Isotonic Saline.
Other: Saline
Saline placebo rinse
Other Name: Isotonic Saline

Active Comparator: 1.5-2% w/v Hydrogen Peroxide
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5-2% w/v hydrogen peroxide rinse.
Drug: 1.5-2% w/v Hydrogen Peroxide
Over-the-counter antiseptic mouth rinse antiseptic mouth rinse
Other Name: Colgate® Optic White®

Active Comparator: 0.12% Chlorhexidine Gluconate
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.
Drug: 0.12% Chlorhexidine Gluconate
Dentist prescribed antimicrobial mouth rinse
Other Name: Peridex™

Active Comparator: 21% Ethanol plus essential oils
Subject participants will rinse mouth one time for 60 seconds with 10 mL 21% ethanol plus essential oils.
Drug: 21% Ethanol plus essential oils
Over-the-counter antiseptic mouth rinse
Other Name: LISTERINE®

Active Comparator: 1% w/v Povidone-iodide
Subject participants will rinse mouth one time for 60 seconds with 10 mL 1% w/v povidone-iodide.
Drug: 1% w/v Povidone-iodide
Over-the-counter broad spectrum iodine antiseptic
Other Name: BETADINE® gargle

Active Comparator: 0.075% Cetylpyridinium Chloride
Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.
Drug: 0.075% Cetylpyridinium Chloride
Over-the-counter antiseptic mouth rinse
Other Name: Colgate Total® Mouthwash




Primary Outcome Measures :
  1. Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 15 Minutes [ Time Frame: Baseline, 15 minutes ]
    Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

  2. Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 30 Minutes [ Time Frame: Baseline, 30 Minutes ]
    Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

  3. Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 45 Minutes [ Time Frame: Baseline, 45 Minutes ]
    Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

  4. Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 60 Minutes [ Time Frame: Baseline, 60 Minutes ]
    Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

  • Diagnosed COVID+ status by physician. Either became symptomatic in the prior 7 days, or if not symptomatic, likely infected/exposed within the prior 7 days.
  • Individuals (all sex, all gender) at least 18 years of age and at most 65 years of age and in good oral health without any known allergies to commercial dental products or cosmetics. American Society of Anesthesiologists (ASA) class I or II prior to COVID infection
  • Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered.
  • Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment.
  • Females of childbearing potential will have a negative urine pregnancy test (on site) or be physically incapable of pregnancy (implants or injections, Intrauterine device, Bilateral tubal ligation, Hysterectomy, Ovariectomy, Women post-menopausal)

Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:

  • Patients who have been eating or drinking within an hour of the study
  • Patients under 18 years old and older than 65 years old
  • Subjects presenting with and/or self-reporting any of the following will not be included in the study:

    • history of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. (self-reported)
    • Self-reported allergy to iodine, ethanol, essential oils (Eucalyptol, Menthol, Methyl salicylate, Thymol), hydrogen peroxide, chlorhexidine gluconate, peroxyl, listerine, betadine, peridex, cetylpyridinium chloride, and other components in the mouth rinses (methyl salicylate, ethanol, saccharin sodium, glycerin, propylene glycol, sorbitol, Federal Food, Drug, and Cosmetic (FD&C) blue no. 1, Poloxamer 407, Benzoic acid, Zinc chloride, Sodium benzoate, Sucralose, PolyEthylene Glycol - 40 (PEG-40) sorbitan diisostearate, potassium sorbate, citric acid).
    • History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject. (Self-reported)
    • A history of severe dry mouth (xerostomia), drug-induced xerostomia (antidepressants, anticonvulsants, antihypertensives), or Sjogren's syndrome
    • A history of recent (within the last 30 days) or current recent oral herpes flare up, candida (thrush) infection, apthous ulcer flare up, current/active severe periodontal disease, or other recent oral viral infection or flare up within the past 30 days (self-reported)
    • Current history of alcohol or drug abuse (self-reported).
    • History of drinking water or eating food within an hour of the study visit.
    • History of drinking alcohol within 12 hours of the study visit.
    • History of using a commercial mouthrinse within 24 hours of the study visit.
    • Participation in any study involving oral care products, concurrently or within the previous 30 days. (self-reported)
    • Positive pregnancy test, reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results. Additionally, women are advised to check with their physician before using Povidone-iodine during pregnancy and lactation, which cannot occur in a blinded, randomized trial.)
    • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial.
    • Patient with developmental/cognitive disability that cannot self-consent, comprehend and follow the requirements of the study based on research site personnel's assessment.
    • Patient who has or ever had a thyroid problem, including swelling (nodular colloid goitre, endemic goitre or Hashimoto's thyroiditis)
    • Patients currently having lithium therapy for depression
    • Patients with sizable mucosal tears, abrasions, growths or burns in the mouth

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): NCT04584684


Contacts
Layout table for location contacts
Contact: Laura Jacox, DMD, PhD 9195373424 ljacox@live.unc.edu

Locations
Layout table for location information
United States, North Carolina
General and Oral Health Center
Chapel Hill, North Carolina, United States, 27599
Contact: Wendy Lamm    919-537-3418    wendy_lamm@unc.edu   
Contact: S.T. Phillips    9195373422    sherrill_phillips@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Layout table for investigator information
Principal Investigator: Laura Jacox, DMD, PhD University of North Carolina, Chapel Hill
Publications:
State Officials Announce Latest COVID-19 Facts Including New Data on Racial Demographics and Expanded Health Care Worker Data. California Department of Public Health (2020).
Sorveglianza Integrata COVID-19 in Italia. Instituto Superiore di Sanitahttps://portale.fnomceo.it/wp-content/uploads/2020/04/Infografica_9aprile-ITA.pdf (2020).
O'Donnell, V. B. et al.Potential Role of Oral Rinses Targeting the Viral Lipid Envelope in SARS-CoV-2 Infection. Function 1, (2020).
Pfefferle, S. et al.Low and high infection dose transmission of SARS-CoV-2 in the first COVID-19 clusters in Northern Germany. medRxiv(2020) doi:10.1101/2020.06.11.20127332.
Kirk-Bayley, J., Challacombe, S., Sunkaraneni, V. & Combes, J. The Use of Povidone Iodine Nasal Spray and Mouthwash During the Current COVID-19 Pandemic May Protect Healthcare Workers and Reduce Cross Infection. SSRN Electron. J.(2020) doi:10.2139/ssrn.3563092.
COVID-19 Frequently Asked Questions. American Dental Assocation: Center for Professional Sucess(2020).

Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04584684    
Other Study ID Numbers: 20-2040
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Study Protocol
Time Frame: following publication up to 1 year
Access Criteria: Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an IRB, IEC, or REB as applicable, and an executed data use/sharing agreement with UNC.

Layout table for additional information
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.: No
Keywords provided by University of North Carolina, Chapel Hill:
Inactivation of COVID SARS-2 Virus
Antiseptic Mouth Rinses
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Chlorhexidine
Chlorhexidine gluconate
Ethanol
Listerine
Hydrogen Peroxide
Cetylpyridinium
Povidone
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes
Cariostatic Agents
Protective Agents