Covid19Phase 2MORNCT04584684
Mouth Rinses for Inactivation of COVID-19
A Phase 2 study testing 0.9% w/v NaCL Saline, 1.5% w/v Hydrogen Peroxide and 0.12% Chlorohexidine Gluconate in people with Covid19 and Coronavirus Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Coronavirus Infection, SARS-CoV-2 Infection
- What is being tested?
- 0.9% w/v NaCL Saline, 1.5% w/v Hydrogen Peroxide and 0.12% Chlorohexidine Gluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 21 Oct 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
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
Trial locations and contacts
1 site in 1 country.
United States1 site
General and Oral Health Center
Chapel Hill, North Carolina, 27599
About this study
Official title: Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus
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.
Read the detailed description
Consenting Procedure Patients will be contacted first by phone and, if not available, then by email. Interested patients will make an appointment to visit the GO Health Clinical Research Unit at Adams School of Dentistry for this study. Study participation includes only one visit. For Spanish speaking patients and/or parents, Spanish forms will be provided and communication will occur through a Spanish translator. All patients are adults and over normal cognitive capacity, and therefore will be able to consent for themselves.
Screening
- At the visit, a consented patient will answer screening questions regarding inclusion and exclusion criteria. Answers will be entered into the Carolina Data Acquisition and Reporting Tool (CDART) research database managed by UNC.
- Prior to finalizing these screening questions, women participants of childbearing potential will be asked to provide a urine sample in the restroom, to undergo a rapid pregnancy test by study personnel. Any pregnant or lactating patients will be excluded.
Enrollment, Baseline, and/or Randomization Outpatient subjects will be recruited from patients seen in the UNC Respiratory Distress Clinic (RDC) who have tested positive for COVID+ and consented to be contacted for participation in COVID-related research studies. The subjects being approached by phone or email have signed a prior facility consent at the Respiratory Distress Clinic confirming willingness to share their name and contact information to be contacted for study participation in COVID related research. Investigators will not receive information on subjects that decline this internal consent. Subjects will be contacted for recruitment by phone and (if unreachable by phone) by secure email by study personnel; patients will have the study rationale and risks explained and will be provided time to ask questions and consider participation. If patients are interested in participating, a single appointment will be scheduled for them at the Adams School of Dentistry GO Health Clinical research core. Consent documentation will be signed in person and in private in the GO Health Clinical Research Core. A list of COVID+ subjects that have consented to be contacted for research, will be provided by the RDC clinic, sent via secure University of North Carolina (UNC) at Chapel Hill NC servers or secure UNC email to the research team's clinical coordinator, and this list will include names and contact details (PHI). This list is updated daily and provided to approved research sites..
Randomization The study statistician will create a block randomization schedule and perform these computations. The researcher in charge of collecting the salivary samples will be blinded to the mouthwash solution, as they will be given a pre-aliquoted mouthrinse in an unlabeled storage tube to provide to the patient for the rinse.
Blinding Subjects will be provided with an unlabeled/blinded mouthrinse. The researcher in charge of collecting the salivary samples will be blinded to the mouthwash solution as well, as they will be given a pre-aliquoted mouthrinse in an unlabeled storage syringe to provide to the patient for the rinse. The study statistician will set up a block randomization schedule that the team will abide by for assignment of enrolled subjects.
Follow-up Visits This study requires only one 70-90 minute, single visit appointment. No diagnostic tests will be run as part of this clinical trial. All participants will already have known COVID+ status, and therefore no follow-up reporting is needed.
Completion/Final Evaluation This study requires only one 70-90 minute, single visit appointment. Subjects will be asked to rinse with an unlabeled/blinded antiviral mouth rinse for 60 seconds and provide 5 mL of saliva prior to the rinse and 2 mL of saliva immediately post-rinse, 15 minutes post-rinse, 30 minutes post-rinse, 45 minutes post-rinse, and 60 minutes post-rinse. Subjects will also be asked to complete a short survey about the rinsing experience.
Subjects may withdraw from the trial at any time or they may be withdrawn at any time at the discretion of the Investigator or Sponsor for safety, behavioral or administrative reasons.
- Conditions
- Covid19, Coronavirus Infection, SARS-CoV-2 Infection
- Being tested
- 0.9% w/v NaCL Saline, 1.5% w/v Hydrogen Peroxide, 0.12% Chlorohexidine Gluconate, 27% Ethanol plus essential oils, 0.5% w/v Povidone-iodide
- Keywords
- Inactivation of COVID SARS-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.
0.9% w/v NaCL SalineOther
saline placebo rinse
1.5% w/v Hydrogen PeroxideDrug
Over-the-counter antiseptic mouth rinse
0.12% Chlorohexidine GluconateDrug
Dentist prescribed antimicrobial mouth rinse
27% Ethanol plus essential oilsDrug
Over-the-counter antiseptic mouth rinse
0.5% w/v Povidone-iodideDrug
Over-the-counter antiseptic mouth rinse
0.075% Cetylpyridinium ChlorideDrug
Over-the-counter antiseptic mouth rinse
| Study group | Role | What they receive |
|---|---|---|
| 0.9% NaCl Saline | Placebo comparator | Subject participants will rinse mouth one time for 60 seconds with 10 mL of Saline. Receives: Other: 0.9% w/v NaCL Saline |
| 27% Ethanol plus essential oils | Active comparator | Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils. Receives: Drug: 27% Ethanol plus essential oils |
| 0.075% Cetylpyridinium Chloride | Active comparator | Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride. Receives: Drug: 0.075% Cetylpyridinium Chloride |
| 1.5% w/v Hydrogen Peroxide | Active comparator | Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse. Receives: Drug: 1.5% w/v Hydrogen Peroxide |
| 0.5% w/v Povidone-iodide | Active comparator | Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide. Receives: Drug: 0.5% w/v Povidone-iodide |
| 0.12% Chlorhexidine Gluconate | Active comparator | Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate. Receives: Drug: 0.12% Chlorohexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Viral RNA Level of SARS-CoV-2
Determination of SARS-CoV-2 viral RNA in COVID+ patient saliva using Quantitative Polymerase Chain Reaction (qPCR).
Measured: Baseline, 30 minutes
Change in Rapid Antigen Test Salivary Protein Levels of SARS-CoV-2
Determination of SARS-CoV-2 protein antigen levels in COVID+ patient saliva using rapid antigen test as back-up if qPCR analysis is not possible. If the Rapid Antigen Test is needed and proves infeasible, an alternative test (i.e., sandwich ELISA) will be used.
Measured: Baseline, 30 Minutes
Change in Salivary Protein Antigen Levels of SARS-CoV-2
Determination of SARS-CoV-2 protein antigen levels in COVID+ patient saliva using sandwich ELISA assay as back-up if qPCR analysis is not possible. If the sandwich ELISA assay proves infeasible, an alternative test (i.e., Rapid Antigen Test) will be used.
Measured: Baseline, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start18 Dec 2020
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Why it stopped: The team decided to terminate the trial in order to start a new trial, unrelated to safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 5 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Jacox, DMD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584684
- Sponsor's protocol ID
- 20-2040
- Acronym
- MOR
- Status last verified
- Feb 2024
- First submitted
- 9 Oct 2020
- Last updated
- 25 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 33215159Harrel 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 15127864Izzetti 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 32302257Ather A, Patel B, Ruparel NB, Diogenes A, Hargreaves KM. Coronavirus Disease 19 (COVID-19): Implications for Clinical Dental Care. J Endod. 2020 May;46(5):584-595. doi: 10.1016/j.joen.2020.03.008. Epub 2020 Apr 6.
PubMed 32273156Baghizadeh 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 32380453Cleveland 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 27233680Pfefferle, 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 32425001Carrouel 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 32326426Dennison 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 7614202Hasheminia 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 29849968Challacombe 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 32385428Kirk-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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus
- ClinicalTrials.gov ID
- NCT04584684
- Acronym / sponsor ID
- MOR / 20-2040
- Conditions
- Covid19, Coronavirus Infection, SARS-CoV-2 Infection
- Keywords
- Inactivation of COVID SARS-2 Virus, Antiseptic Mouth Rinses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The team decided to terminate the trial in order to start a new trial, unrelated to safety reasons
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 25 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Consenting Procedure Patients will be contacted first by phone and, if not available, then by email. Interested patients will make an appointment to visit the GO Health Clinical Research Unit at Adams School of Dentistry for this study. Study participation includes only one visit. For Spanish speaking patients and/or parents, Spanish forms will be provided and communication will occur through a Spanish translator. All patients are adults and over normal cognitive capacity, and therefore will be able to consent for themselves.
Screening
- At the visit, a consented patient will answer screening questions regarding inclusion and exclusion criteria. Answers will be entered into the Carolina Data Acquisition and Reporting Tool (CDART) research database managed by UNC.
- Prior to finalizing these screening questions, women participants of childbearing potential will be asked to provide a urine sample in the restroom, to undergo a rapid pregnancy test by study personnel. Any pregnant or lactating patients will be excluded.
Enrollment, Baseline, and/or Randomization Outpatient subjects will be recruited from patients seen in the UNC Respiratory Distress Clinic (RDC) who have tested positive for COVID+ and consented to be contacted for participation in COVID-related research studies. The subjects being approached by phone or email have signed a prior facility consent at the Respiratory Distress Clinic confirming willingness to share their name and contact information to be contacted for study participation in COVID related research. Investigators will not receive information on subjects that decline this internal consent. Subjects will be contacted for recruitment by phone and (if unreachable by phone) by secure email by study personnel; patients will have the study rationale and risks explained and will be provided time to ask questions and consider participation. If patients are interested in participating, a single appointment will be scheduled for them at the Adams School of Dentistry GO Health Clinical research core. Consent documentation will be signed in person and in private in the GO Health Clinical Research Core. A list of COVID+ subjects that have consented to be contacted for research, will be provided by the RDC clinic, sent via secure University of North Carolina (UNC) at Chapel Hill NC servers or secure UNC email to the research team's clinical coordinator, and this list will include names and contact details (PHI). This list is updated daily and provided to approved research sites..
Randomization The study statistician will create a block randomization schedule and perform these computations. The researcher in charge of collecting the salivary samples will be blinded to the mouthwash solution, as they will be given a pre-aliquoted mouthrinse in an unlabeled storage tube to provide to the patient for the rinse.
Blinding Subjects will be provided with an unlabeled/blinded mouthrinse. The researcher in charge of collecting the salivary samples will be blinded to the mouthwash solution as well, as they will be given a pre-aliquoted mouthrinse in an unlabeled storage syringe to provide to the patient for the rinse. The study statistician will set up a block randomization schedule that the team will abide by for assignment of enrolled subjects.
Follow-up Visits This study requires only one 70-90 minute, single visit appointment. No diagnostic tests will be run as part of this clinical trial. All participants will already have known COVID+ status, and therefore no follow-up reporting is needed.
Completion/Final Evaluation This study requires only one 70-90 minute, single visit appointment. Subjects will be asked to rinse with an unlabeled/blinded antiviral mouth rinse for 60 seconds and provide 5 mL of saliva prior to the rinse and 2 mL of saliva immediately post-rinse, 15 minutes post-rinse, 30 minutes post-rinse, 45 minutes post-rinse, and 60 minutes post-rinse. Subjects will also be asked to complete a short survey about the rinsing experience.
Subjects may withdraw from the trial at any time or they may be withdrawn at any time at the discretion of the Investigator or Sponsor for safety, behavioral or administrative reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized, placebo-controlled, double-blind prospective trial to test the efficacy and acceptability of 5 therapeutic, antiseptic mouth rinses to inactivate SARS-CoV-2 virus in saliva of COVID-19 positive patients.
| Arm | Type | Receives |
|---|---|---|
| 0.9% NaCl Saline | Placebo comparator | Other: 0.9% w/v NaCL SalineSubject participants will rinse mouth one time for 60 seconds with 10 mL of Saline. |
| 27% Ethanol plus essential oils | Active comparator | Drug: 27% Ethanol plus essential oilsSubject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils. |
| 0.075% Cetylpyridinium Chloride | Active comparator | Drug: 0.075% Cetylpyridinium ChlorideSubject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride. |
| 1.5% w/v Hydrogen Peroxide | Active comparator | Drug: 1.5% w/v Hydrogen PeroxideSubject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse. |
| 0.5% w/v Povidone-iodide | Active comparator | Drug: 0.5% w/v Povidone-iodideSubject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide. |
| 0.12% Chlorhexidine Gluconate | Active comparator | Drug: 0.12% Chlorohexidine GluconateSubject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9% w/v NaCL Salinesaline placebo rinse | Other | 0.9% NaCl Saline |
| 1.5% w/v Hydrogen PeroxideOver-the-counter antiseptic mouth rinse | Drug | 1.5% w/v Hydrogen Peroxide |
| 0.12% Chlorohexidine GluconateDentist prescribed antimicrobial mouth rinse | Drug | 0.12% Chlorhexidine Gluconate |
| 27% Ethanol plus essential oilsOver-the-counter antiseptic mouth rinse | Drug | 27% Ethanol plus essential oils |
| 0.5% w/v Povidone-iodideOver-the-counter antiseptic mouth rinse | Drug | 0.5% w/v Povidone-iodide |
| 0.075% Cetylpyridinium ChlorideOver-the-counter antiseptic mouth rinse | Drug | 0.075% Cetylpyridinium Chloride |
Primary outcome
Change in Salivary Viral RNA Level of SARS-CoV-2
Time frame: Baseline, 30 minutes
Determination of SARS-CoV-2 viral RNA in COVID+ patient saliva using Quantitative Polymerase Chain Reaction (qPCR).
Change in Rapid Antigen Test Salivary Protein Levels of SARS-CoV-2
Time frame: Baseline, 30 Minutes
Determination of SARS-CoV-2 protein antigen levels in COVID+ patient saliva using rapid antigen test as back-up if qPCR analysis is not possible. If the Rapid Antigen Test is needed and proves infeasible, an alternative test (i.e., sandwich ELISA) will be used.
Change in Salivary Protein Antigen Levels of SARS-CoV-2
Time frame: Baseline, 30 minutes
Determination of SARS-CoV-2 protein antigen levels in COVID+ patient saliva using sandwich ELISA assay as back-up if qPCR analysis is not possible. If the sandwich ELISA assay proves infeasible, an alternative test (i.e., Rapid Antigen Test) will be used.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundState Officials Announce Latest COVID-19 Facts Including New Data on Racial Demographics and Expanded Health Care Worker Data. California Department of Public Health (2020).
- BackgroundSorveglianza Integrata COVID-19 in Italia. Instituto Superiore di Sanitahttps://portale.fnomceo.it/wp-content/uploads/2020/04/Infografica_9aprile-ITA.pdf (2020).
- Background: PubMed 33215159O'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.
- Background: PubMed 15127864Harrel 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.
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- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Jacox, DMD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.9% w/v NaCL Saline, 1.5% w/v Hydrogen Peroxide and 0.12% Chlorohexidine Gluconate 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?
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 25 Mar 2024. 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 25 Mar 2024). 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 Salivary Viral RNA Level of SARS-CoV-2 (time frame: Baseline, 30 minutes). The study lists 3 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 NCT04584684, which also lists 17 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 25 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.