Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19

NCT04748783 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 20-3046COL Study
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects (125) will be randomized to one of five mouthrinses and will be asked to give a saliva sample immediately before and after a 30-60 second mouthwash. Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva will be used for RT-PCR detection of Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex). Subjects will complete a short survey on the taste and experience of using the mouthwash. Peripheral blood will be collected at the end of salivary collection. Subjects, except controls, will be provided materials and oral hygiene instruction related to daily use of oral hygiene products. In the seven-day period between study visit one and study visit two, subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse with the Colgate mouthrinse (according to on-label procedures). Controls are asked to carry out their typical oral hygiene regimen with the products they typically use. All subjects keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures. Subjects complete study visit two one week after the baseline visit during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse) will occur and blood samples collected. each subject will undergo a periodontal exam.

Conditions

COVID19; Coronavirus Infection; SARS CoV-2 Infection

Keywords

Inactivation of SARS CoV-2 Virus; Antiseptic Mouth Rinses

Outcome Measures

Primary Outcomes (5)

• Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) Baseline to 15 Min

  Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

  Baseline, 15 minutes

• Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) From Baseline to 30 Minutes

  Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

  Baseline, 30 Minutes

• Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) From Baseline to 45 Minutes

  Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient

  Baseline, 45 Minutes

• Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) From Baseline to 60 Minutes

  Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient

  Baseline, 60 minutes

• Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) From Baseline to 1-week.

  Determination of (RT-PCR) of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient

  Baseline, 1 week

Secondary Outcomes (4)

• Change in Saliva Cytokine Concentration

  Baseline, 1 week

• Change in Blood Cytokine Concentration

  Baseline, 1 week

• Change in Saliva Chemokine Concentration

  Baseline, 1 week

• Change in Blood Chemokine Concentration

  Baseline, 1 week

Study Arms (5)

Sterile water

PLACEBO COMPARATOR

Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water

Other: Water

Peroxyl

ACTIVE COMPARATOR

Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse

Other: Peroxyl

Periogard

ACTIVE COMPARATOR

Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.

Drug: Periogard

Peroxyl & Periogard

ACTIVE COMPARATOR

Subject participants will complete an on-label sequential rinse starting with Peroxyl (1st) 10ml for 60 seconds and then Periogard (2nd) 15ml for 30 seconds.

Other: Peroxyl; Drug: Periogard

Colgate Total Zero

ACTIVE COMPARATOR

Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20ml for 30 seconds

Other: Colgate Total Zero

Interventions

Water OTHER

Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water.

Also known as: Sterile Water

Sterile water

Peroxyl OTHER

Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse

Also known as: Colgate® Peroxyl® Mouth Sore Rinse

Peroxyl; Peroxyl & Periogard

Periogard DRUG

Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.

Also known as: Colgate® PerioGard® Rinse

Periogard; Peroxyl & Periogard

Colgate Total Zero OTHER

Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20ml for 30 seconds

Also known as: Colgate Total® Mouthwash

Colgate Total Zero

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Colgate Palmolive: collaborator

Study Sites (1)

Adams School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Water; Hydrogen Peroxide; Chlorhexidine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Peroxides; Reactive Oxygen Species; Free Radicals; Organic Chemicals; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Laura Jacox, DMD, PhD, MS
• Organization: University of North Carolina at Chapel Hill

ljacox@live.unc.edu

919-537-3424

Study Officials

• Laura a Jacox, DMD, PhD, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blind prospective trial to test the efficacy and acceptability of 4 therapeutic, antiseptic mouth rinses to inactivate SARS-CoV-2 virus in saliva of COVID-19 positive patients

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 10, 2021
• Study Start: March 26, 2021
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: February 16, 2022
• Results First Posted: February 16, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication up to 1 year
• Access Criteria: 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.

Locations

US (1)