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COVID19Phase 2COLNCT04748783

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

A Phase 2 study testing Water, Peroxyl and Periogard in people with COVID19 and Coronavirus Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Water, Peroxyl and Periogard
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
1 siteUnited States
Study dates
26 Mar 2021to 7 Apr 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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).
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Adams School of Dentistry

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus

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).

Read more

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.

Read the detailed description

Randomized, double-blind prospective trial to test the efficacy and acceptability of therapeutic, antiseptic mouth rinses to inactivate SARS-CoV-2 virus in saliva of SARS-CoV-2+ patients 18-65 years of age. The study will enroll 30 outpatient SARS-CoV-2+ subjects per mouth rinse, (to achieve a total of 25 subjects with full data sets per mouth rinse,) with 5 mouth rinses, requiring us to enroll 125 SARS-CoV-2+ patients. Patients will be randomized to their mouthrinse. These patients will have already had a confirmed SARS-CoV-2+ test prior to enrollment. There will be no stratification to our randomization. All mouthrinses are commercially available Colgate products and will be used according to on-label instructions.

Subjects will be randomized to a mouthrinse 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 samples will be stored and used for RT-PCR detection of SARS-CoV-2 virus and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex).

Subjects will also 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 provided by the study. In the seven-day period between study visits, 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 not given Colgate products and will be asked to carry out their typical oral hygiene regimen with the products they typically use. All subjects will be asked to keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures.

Subjects will be scheduled to return to the research clinic at one week after the baseline assessment, during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse will occur) and blood samples will be collected. At the conclusion of sample collection, the subject will undergo a periodontal exam. Study participation concludes following the periodontal exam at the end of the second on site study visit. Patients with any periodontitis or gingivitis diagnosis will be informed of their diagnosis and will be referred to an oral healthcare provider for further treatment. This study involves two 90-minute visits.

Being tested
Water, Peroxyl, Periogard, Colgate Total Zero
Keywords
Inactivation of SARS CoV-2 Virus, Antiseptic Mouth Rinses
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WaterOther

    Also called Sterile Water

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

  • PeroxylOther

    Also called Colgate® Peroxyl® Mouth Sore Rinse

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

  • PeriogardDrug

    Also called Colgate® PerioGard® Rinse

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

  • Colgate Total ZeroOther

    Also called Colgate Total® Mouthwash

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

Study groups in NCT04748783
Study groupRoleWhat they receive
Sterile waterPlacebo comparatorSubject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water
Receives: Other: Water
PeroxylActive comparatorSubject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
Receives: Other: Peroxyl
PeriogardActive comparatorSubject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
Receives: Drug: Periogard
Peroxyl & PeriogardActive comparatorSubject participants will complete an on-label sequential rinse starting with Peroxyl (1st) 10ml for 60 seconds and then Periogard (2nd) 15ml for 30 seconds.
Receives: Other: Peroxyl; Drug: Periogard
Colgate Total ZeroActive comparatorSubject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20ml for 30 seconds
Receives: Other: Colgate Total Zero

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 15 minutes

  2. 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

    Measured: Baseline, 30 Minutes

  3. 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

    Measured: Baseline, 45 Minutes

  4. 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

    Measured: Baseline, 60 minutes

  5. 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

    Measured: Baseline, 1 week

Secondary outcomes (4)

  1. Change in Saliva Cytokine Concentration

    Change in inflammation-associated cytokine concentration (pg/mL) in saliva

    Measured: Baseline, 1 week

  2. Change in Blood Cytokine Concentration

    Change in inflammation-associated cytokine concentration (pg/mL) in Blood

    Measured: Baseline, 1 week

  3. Change in Saliva Chemokine Concentration

    Change in inflammation-associated chemokine concentration (pg/mL) in saliva

    Measured: Baseline, 1 week

  4. Change in Blood Chemokine Concentration

    Change in inflammation-associated chemokine concentration (pg/mL) in Blood

    Measured: Baseline, 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start26 Mar 2021
  3. Primary completion7 Apr 2021
  4. Study completion7 Apr 2021

Why it stopped: Funding withdrawn

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04748783
Sponsor's protocol ID
20-3046
Other IDs
COL Study
Acronym
COL
Status last verified
Apr 2021
First submitted
9 Feb 2021
Last updated
16 Feb 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

  • 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).

  • Sorveglianza Integrata COVID-19 in Italia. Instituto Superiore di Sanitahttps://portale.fnomceo.it/wp-content/uploads/2020/04/Infografica_9aprile-ITA.pdf (2020).

  • 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.

    PubMed 33215159

  • 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.

    PubMed 15127864

  • 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.

    PubMed 32302257

  • Ather A, Patel B, Ruparel NB, Diogenes A, Hargreaves KM. Reply to "Coronavirus Disease 19 (COVID-19): Implications for Clinical Dental Care". J Endod. 2020 Sep;46(9):1342. doi: 10.1016/j.joen.2020.08.005. Epub 2020 Aug 15. No abstract available.

    PubMed 32810475

  • 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.

    PubMed 32380453

  • 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.

    PubMed 27233680

  • 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

  • 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.

    PubMed 32425001

  • 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.

    PubMed 32326426

  • 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.

    PubMed 7614202

  • 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.

    PubMed 29849968

  • 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.

    PubMed 32385428

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Water, Peroxyl and Periogard in people with COVID19 and Coronavirus Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Reverse Transcription Polymerase Chain Reaction (RT-PCR) Baseline to 15 Min (time frame: Baseline, 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04748783, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.

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