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Mouth Rinses for Inactivation of COVID-19 (MOR)

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ClinicalTrials.gov Identifier: NCT04584684
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE October 9, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE December 18, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mouth Rinses for Inactivation of COVID-19
Official Title  ICMJE Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus
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.
Detailed Description

Consenting Procedure Patients will be contacted first by phone and, if not available, then by email. Interested patients will make an appointment to visit the GO Health Clinical Research Unit at Adams School of Dentistry for this study. Study participation includes only one visit. For Spanish speaking patients and/or parents, Spanish forms will be provided and communication will occur through a Spanish translator. All patients are adults and over normal cognitive capacity, and therefore will be able to consent for themselves.

Screening

  • At the visit, a consented patient will answer screening questions regarding inclusion and exclusion criteria. Answers will be entered into the Carolina Data Acquisition and Reporting Tool (CDART) research database managed by UNC.
  • Prior to finalizing these screening questions, women participants of childbearing potential will be asked to provide a urine sample in the restroom, to undergo a rapid pregnancy test by study personnel. Any pregnant or lactating patients will be excluded.

Enrollment, Baseline, and/or Randomization Outpatient subjects will be recruited from patients seen in the UNC Respiratory Distress Clinic (RDC) who have tested positive for COVID+ and consented to be contacted for participation in COVID-related research studies. The subjects being approached by phone or email have signed a prior facility consent at the Respiratory Distress Clinic confirming willingness to share their name and contact information to be contacted for study participation in COVID related research. Investigators will not receive information on subjects that decline this internal consent. Subjects will be contacted for recruitment by phone and (if unreachable by phone) by secure email by study personnel; patients will have the study rationale and risks explained and will be provided time to ask questions and consider participation. If patients are interested in participating, a single appointment will be scheduled for them at the Adams School of Dentistry GO Health Clinical research core. Consent documentation will be signed in person and in private in the GO Health Clinical Research Core. A list of COVID+ subjects that have consented to be contacted for research, will be provided by the RDC clinic, sent via secure University of North Carolina (UNC) at Chapel Hill NC servers or secure UNC email to the research team's clinical coordinator, and this list will include names and contact details (PHI). This list is updated daily and provided to approved research sites..

Randomization The study statistician will create a block randomization schedule and perform these computations. The researcher in charge of collecting the salivary samples will be blinded to the mouthwash solution, as they will be given a pre-aliquoted mouthrinse in an unlabeled storage tube to provide to the patient for the rinse.

Blinding Subjects will be provided with an unlabeled/blinded mouthrinse. The researcher in charge of collecting the salivary samples will be blinded to the mouthwash solution as well, as they will be given a pre-aliquoted mouthrinse in an unlabeled storage syringe to provide to the patient for the rinse. The study statistician will set up a block randomization schedule that the team will abide by for assignment of enrolled subjects.

Follow-up Visits This study requires only one 70-90 minute, single visit appointment. No diagnostic tests will be run as part of this clinical trial. All participants will already have known COVID+ status, and therefore no follow-up reporting is needed.

Completion/Final Evaluation This study requires only one 70-90 minute, single visit appointment. Subjects will be asked to rinse with an unlabeled/blinded antiviral mouth rinse for 60 seconds and provide 5 mL of saliva prior to the rinse and 2 mL of saliva immediately post-rinse, 15 minutes post-rinse, 30 minutes post-rinse, 45 minutes post-rinse, and 60 minutes post-rinse. Subjects will also be asked to complete a short survey about the rinsing experience.

Subjects may withdraw from the trial at any time or they may be withdrawn at any time at the discretion of the Investigator or Sponsor for safety, behavioral or administrative reasons.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Covid19
  • Coronavirus Infection
  • SARS-CoV-2 Infection
Intervention  ICMJE
  • Drug: 1.5% w/v Hydrogen Peroxide
    Over-the-counter antiseptic mouth rinse antiseptic mouth rinse
  • Drug: 0.12% Chlorhexidine Gluconate
    Dentist prescribed antimicrobial mouth rinse
  • Drug: 27% Ethanol plus essential oils
    Over-the-counter antiseptic mouth rinse
  • Drug: 0.5% w/v Povidone-iodide
    Over-the-counter broad spectrum iodine antiseptic
  • Drug: 0.075% Cetylpyridinium Chloride
    Over-the-counter antiseptic mouth rinse
  • Other: Saline
    Saline placebo rinse
    Other Name: Isotonic Saline
Study Arms  ICMJE
  • Placebo Comparator: Saline
    Subject participants will rinse mouth one time for 60 seconds with 10 mL of Isotonic Saline.
    Intervention: Other: Saline
  • Active Comparator: 1.5% w/v Hydrogen Peroxide
    Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse.
    Intervention: Drug: 1.5% w/v Hydrogen Peroxide
  • Active Comparator: 0.12% Chlorhexidine Gluconate
    Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.
    Intervention: Drug: 0.12% Chlorhexidine Gluconate
  • Active Comparator: 27% Ethanol plus essential oils
    Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils.
    Intervention: Drug: 27% Ethanol plus essential oils
  • Active Comparator: 0.5% w/v Povidone-iodide
    Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide.
    Intervention: Drug: 0.5% w/v Povidone-iodide
  • Active Comparator: 0.075% Cetylpyridinium Chloride
    Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.
    Intervention: Drug: 0.075% Cetylpyridinium Chloride
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2020)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Laura Jacox, DMD, PhD 9195373424 ljacox@live.unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04584684
Other Study ID Numbers  ICMJE 20-2040
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.: No
IPD Sharing Statement  ICMJE
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.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Jacox, DMD, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date April 2021

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