Mouth Rinses for Inactivation of COVID-19 (MOR)
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ClinicalTrials.gov Identifier: NCT04584684 |
Recruitment Status :
Terminated
(The team decided to terminate the trial in order to start a new trial, unrelated to safety reasons)
First Posted : October 14, 2020
Results First Posted : March 25, 2024
Last Update Posted : March 25, 2024
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Condition or disease | Intervention/treatment | Phase |
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Covid19 Coronavirus Infection SARS-CoV-2 Infection | Other: 0.9% w/v NaCL Saline Drug: 1.5% w/v Hydrogen Peroxide Drug: 0.12% Chlorohexidine Gluconate Drug: 27% Ethanol plus essential oils Drug: 0.5% w/v Povidone-iodide Drug: 0.075% Cetylpyridinium Chloride | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus |
Actual Study Start Date : | December 18, 2020 |
Actual Primary Completion Date : | October 21, 2021 |
Actual Study Completion Date : | October 21, 2021 |
Arm | Intervention/treatment |
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Placebo Comparator: 0.9% NaCl Saline
Subject participants will rinse mouth one time for 60 seconds with 10 mL of Saline.
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Other: 0.9% w/v NaCL Saline
saline placebo rinse |
Active Comparator: 27% Ethanol plus essential oils
Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils.
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Drug: 27% Ethanol plus essential oils
Over-the-counter antiseptic mouth rinse |
Active Comparator: 0.075% Cetylpyridinium Chloride
Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride.
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Drug: 0.075% Cetylpyridinium Chloride
Over-the-counter antiseptic mouth rinse |
Active Comparator: 1.5% w/v Hydrogen Peroxide
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse.
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Drug: 1.5% w/v Hydrogen Peroxide
Over-the-counter antiseptic mouth rinse |
Active Comparator: 0.5% w/v Povidone-iodide
Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide.
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Drug: 0.5% w/v Povidone-iodide
Over-the-counter antiseptic mouth rinse |
Active Comparator: 0.12% Chlorhexidine Gluconate
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate.
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Drug: 0.12% Chlorohexidine Gluconate
Dentist prescribed antimicrobial mouth rinse |
- 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.
- Change in Salivary Viral Infectivity of SARS-CoV-2 [ Time Frame: Baseline, 30 Minutes ]Determination of SARS-CoV-2 viral infectivity using an in vitro infectivity assay.
- Participants' Willingness to Use Mouthrinse [ Time Frame: After using mouthrinse, between 0-minute and 15-minute saliva collection ]The Mouthrinse questionnaire was used to understand the acceptability of mouthrinse use by participants in a clinical setting. It asks participants to respond to 14 questions answering the following: "As I read the following list of situations, please tell me how willing you would be to using a mouth rinse in that situation." Possible responses for each question are: ("Very willing"; "Somewhat willing"; "Somewhat unwilling"; "Very unwilling"; and "NA").
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584684
United States, North Carolina | |
General and Oral Health Center | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Laura Jacox, DMD, PhD | University of North Carolina, Chapel Hill |
Documents provided by University of North Carolina, Chapel Hill:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT04584684 |
Other Study ID Numbers: |
20-2040 |
First Posted: | October 14, 2020 Key Record Dates |
Results First Posted: | March 25, 2024 |
Last Update Posted: | March 25, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol |
Time Frame: | following publication up to 1 year |
Access Criteria: | 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 IRB, IEC, or REB as applicable, and an executed data use/sharing agreement with UNC. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Inactivation of COVID SARS-2 Virus Antiseptic Mouth Rinses |
Infections Communicable Diseases COVID-19 Coronavirus Infections Disease Attributes Pathologic Processes Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Ethanol Hydrogen Peroxide Cetylpyridinium Povidone Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs Plasma Substitutes Blood Substitutes |