Mouth Rinses for Inactivation of COVID-19

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Cetylpyridinium; Chlorhexidine; Chlorhexidine gluconate; Ethanol; Hydrogen Peroxide; Listerine; Povidone; Sodium Fluoride

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