COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04748783

Laura A Jacox, DMD, PhD, Ms

ljacox@live.unc.edu

2021-02-10

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study: - diagnosed sars-cov-2+ status. either became symptomatic in the prior 7 days, or if not symptomatic, likely infected/exposed within the prior 7 days. all patients listed from the university of north carolina at chapel hill (unc) respiratory diagnostic center (rdc) have a confirmed sars-cov-2 infection and have consented to be contacted for research purposes. for patients contacting study coordinators for enrollment, who were not tested in the rdc, they must provide written proof of positive sars-cov-2 status in 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 anaesthesiologists (asa) class i or ii prior to sars-cov-2 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)

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 of age and older than 65 years of age - 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 hydrogen peroxide, peroxyl, chlorhexidine gluconate, periogard, peridex, colgate total zero, colgate total, cetylpyridinium chloride, essential oils (eucalyptol, menthol, methyl salicylate, thymol), and other components in the mouth rinses (methyl salicylate, ethanol, saccharin sodium, glycerin, propylene glycol, sorbitol, federal food, drug, and cosmetic (fd&c) blue additive no. 1, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, polyethylene glycol (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), severe 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 chlorhexidine gluconate during pregnancy and lactation, which cannot occur in a blinded, randomized trial.) - other severe acute or chronic medical or psychiatric conditions 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. - patients with sizable mucosal tears, abrasions, growths or burns in the mouth - patients with kidney dysfunction

5

University of North Carolina, Chapel Hill

18

65

United States

Mild disease at enrollment

1: Mild disease at enrollment

2

Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) Baseline to 15 Min;Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) From Baseline to 1-week.;Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) From Baseline to 30 Minutes;Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) From Baseline to 45 Minutes;Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) From Baseline to 60 Minutes

None

Phase 2

[{"arm_notes": "", "treatment_id": 606, "treatment_name": "Hydrogen peroxide", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 274, "treatment_name": "Chlorhexidine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1531, "treatment_name": "Chlorhexidine+hydrogen peroxide", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 268, "treatment_name": "Cetylpyridinium chloride", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]