Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
128 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-12-18
Study Completion Date
2021-10-21
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Covid19
Coronavirus Infection
SARS-CoV-2 Infection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
Study Groups
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0.9% NaCl Saline
Subject participants will rinse mouth one time for 60 seconds with 10 mL of Saline.
Group Type
PLACEBO_COMPARATOR
0.9% w/v NaCL Saline
Intervention Type
OTHER
saline placebo rinse
27% Ethanol plus essential oils
Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils.
Group Type
ACTIVE_COMPARATOR
27% Ethanol plus essential oils
Intervention Type
DRUG
Over-the-counter antiseptic mouth rinse
0.075% Cetylpyridinium Chloride
Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.
Group Type
ACTIVE_COMPARATOR
0.075% Cetylpyridinium Chloride
Intervention Type
DRUG
Over-the-counter antiseptic mouth rinse
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.
Group Type
ACTIVE_COMPARATOR
1.5% w/v Hydrogen Peroxide
Intervention Type
DRUG
Over-the-counter antiseptic mouth rinse
0.5% w/v Povidone-iodide
Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide.
Group Type
ACTIVE_COMPARATOR
0.5% w/v Povidone-iodide
Intervention Type
DRUG
Over-the-counter antiseptic mouth rinse
0.12% Chlorhexidine Gluconate
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.
Group Type
ACTIVE_COMPARATOR
0.12% Chlorohexidine Gluconate
Intervention Type
DRUG
Dentist prescribed antimicrobial mouth rinse
Interventions
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0.9% w/v NaCL Saline
saline placebo rinse
Intervention Type
OTHER
1.5% w/v Hydrogen Peroxide
Over-the-counter antiseptic mouth rinse
Intervention Type
DRUG
0.12% Chlorohexidine Gluconate
Dentist prescribed antimicrobial mouth rinse
Intervention Type
DRUG
27% Ethanol plus essential oils
Over-the-counter antiseptic mouth rinse
Intervention Type
DRUG
0.5% w/v Povidone-iodide
Over-the-counter antiseptic mouth rinse
Intervention Type
DRUG
0.075% Cetylpyridinium Chloride
Over-the-counter antiseptic mouth rinse
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Laura Jacox, DMD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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General and Oral Health Center
Chapel Hill, North Carolina, United States
Site Status
Countries
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United States
References
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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).
Reference Type
BACKGROUND
Sorveglianza Integrata COVID-19 in Italia. Instituto Superiore di Sanitahttps://portale.fnomceo.it/wp-content/uploads/2020/04/Infografica_9aprile-ITA.pdf (2020).
Reference Type
BACKGROUND
O'Donnell VB, Thomas D, Stanton R, Maillard JY, Murphy RC, Jones SA, Humphreys I, Wakelam MJO, Fegan C, Wise MP, Bosch A, Sattar SA. Potential Role of Oral Rinses Targeting the Viral Lipid Envelope in SARS-CoV-2 Infection. Function (Oxf). 2020;1(1):zqaa002. doi: 10.1093/function/zqaa002. Epub 2020 Jun 5.
Reference Type
BACKGROUND
Harrel SK, Molinari J. Aerosols and splatter in dentistry: a brief review of the literature and infection control implications. J Am Dent Assoc. 2004 Apr;135(4):429-37. doi: 10.14219/jada.archive.2004.0207.
Reference Type
BACKGROUND
Izzetti R, Nisi M, Gabriele M, Graziani F. COVID-19 Transmission in Dental Practice: Brief Review of Preventive Measures in Italy. J Dent Res. 2020 Aug;99(9):1030-1038. doi: 10.1177/0022034520920580. Epub 2020 Apr 17.
Reference Type
BACKGROUND
Ather A, Patel B, Ruparel NB, Diogenes A, Hargreaves KM. Coronavirus Disease 19 (COVID-19): Implications for Clinical Dental Care. J Endod. 2020 May;46(5):584-595. doi: 10.1016/j.joen.2020.03.008. Epub 2020 Apr 6.
Reference Type
BACKGROUND
Baghizadeh Fini M. What dentists need to know about COVID-19. Oral Oncol. 2020 Jun;105:104741. doi: 10.1016/j.oraloncology.2020.104741. Epub 2020 Apr 28.
Reference Type
BACKGROUND
Cleveland JL, Gray SK, Harte JA, Robison VA, Moorman AC, Gooch BF. Transmission of blood-borne pathogens in US dental health care settings: 2016 update. J Am Dent Assoc. 2016 Sep;147(9):729-38. doi: 10.1016/j.adaj.2016.03.020. Epub 2016 May 24.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Ge ZY, Yang LM, Xia JJ, Fu XH, Zhang YZ. Possible aerosol transmission of COVID-19 and special precautions in dentistry. J Zhejiang Univ Sci B. 2020 May;21(5):361-368. doi: 10.1631/jzus.B2010010. Epub 2020 Mar 16.
Reference Type
BACKGROUND
Carrouel F, Conte MP, Fisher J, Goncalves LS, Dussart C, Llodra JC, Bourgeois D. COVID-19: A Recommendation to Examine the Effect of Mouthrinses with beta-Cyclodextrin Combined with Citrox in Preventing Infection and Progression. J Clin Med. 2020 Apr 15;9(4):1126. doi: 10.3390/jcm9041126.
Reference Type
BACKGROUND
Dennison DK, Meredith GM, Shillitoe EJ, Caffesse RG. The antiviral spectrum of Listerine antiseptic. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Apr;79(4):442-8. doi: 10.1016/s1079-2104(05)80124-6.
Reference Type
BACKGROUND
Hasheminia D, Moaddabi A, Moradi S, Soltani P, Moannaei M, Issazadeh M. The efficacy of 1% Betadine mouthwash on the incidence of dry socket after mandibular third molar surgery. J Clin Exp Dent. 2018 May 1;10(5):e445-e449. doi: 10.4317/jced.54444. eCollection 2018 May.
Reference Type
BACKGROUND
Challacombe SJ, Kirk-Bayley J, Sunkaraneni VS, Combes J. Povidone iodine. Br Dent J. 2020 May;228(9):656-657. doi: 10.1038/s41415-020-1589-4. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
COVID-19 Frequently Asked Questions. American Dental Assocation: Center for Professional Sucess(2020).
Reference Type
BACKGROUND
Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020 Jun 9;323(22):2249-2251. doi: 10.1001/jama.2020.8259. No abstract available.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-2040
Identifier Type: -
Identifier Source: org_study_id
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