Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19
Condition: COVID19; Coronavirus Infection; SARS CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections
Intervention: Water; Peroxyl; Periogard; Colgate Total Zero
Intervention description: Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water.; Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse; Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.; Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20ml for 30 seconds
Intervention MeSH terms: Listerine; Chlorhexidine; Chlorhexidine gluconate; Hydrogen Peroxide; Sodium Fluoride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inactivation of SARS CoV-2 Virus; Antiseptic Mouth Rinses

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.
    

Eligibility criteria:

        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)

        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 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