Efficacy of Mouthwash in Reducing Salivary Carriage of COVID-19
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ClinicalTrials.gov Identifier: NCT04603794 |
Recruitment Status :
Recruiting
First Posted : October 27, 2020
Last Update Posted : October 27, 2020
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: 0.5% Povidone Iodine Drug: 0.12% Chlorhexidine Gluconate Mouth Rinse Drug: 1% Hydrogen Peroxide Drug: 0.9% Normal Saline | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This randomized, cross-sectional, double blinded, negative controlled, four armed, prospective, interventional study compared Normal Saline, Hydrogen Peroxide, Chlorhexidine and Povidone-Iodine Mouth Rinses in 60 subjects being treated for Covid 19 at the The Ohio State University Medical Center. Real time reverse transcriptase quantitative PCR measured viral loads. |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | Double Blinded. All mouthwash vials are masked. |
Primary Purpose: | Prevention |
Official Title: | Comparison of Normal Saline, Hydrogen Peroxide, Chlorhexidine and Povidone-Iodine Mouth Rinses in COVID-19 Patients |
Actual Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | November 2020 |
Estimated Study Completion Date : | November 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1% Hydrogen Peroxide Mouth Rinse
30 second oral rinse with 1% Hydrogen Peroxide
|
Drug: 1% Hydrogen Peroxide
Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)
Other Name: Hydrogen Peroxide |
Active Comparator: 0.12% Chlorhexidine Gluconate Mouth Rinse
30 second oral rinse with 0.12% Chlorhexidine Gluconate
|
Drug: 0.12% Chlorhexidine Gluconate Mouth Rinse
Commercially Available Mouth Rinses
Other Name: Peridex |
Active Comparator: 0.5% Povidone Iodine Mouth Rinse
30 second oral rinse with 0.5% Povidone Iodine Mouth wash
|
Drug: 0.5% Povidone Iodine
Commercially Available Mouth Rinses and Over the Counter Standard Formulations
Other Name: Betadine Mouthwash |
Placebo Comparator: 0.9% Normal Saline Mouth Rinse
30 second oral rinse with 0.9% Normal Saline
|
Drug: 0.9% Normal Saline
Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)
Other Name: Salt Water |
- real time reverse transcriptase quantitative PCR [ Time Frame: 3 measurements of changes from times 0 minutes. vs:15 minutes, and vs: 45 minutes during a single session ]Saliva load was expressed in copies x 10 8 of COVID-19 RNA
- ct values [ Time Frame: 3 measurements of changes from times 0 minutes.vs:15 minutes, and vs:45 minutes during a single session ]cycle thresholds

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adults age 18-80 admitted to The Ohio State University Medical Center,
- diagnosis of COVID-19 confirmed by Polymerase Chain Reaction (PCR),
- salivary carriage of COVID-19 virus
- ability to perform mouthwash rinses and to expectorate.
Exclusion Criteria:
- allergy to any study mouth rinse,
- active uncontrolled thyroid disease,
- pregnancy
- patients undergoing radioactive iodine therapy.

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): NCT04603794
Contact: David L Hall, DDS | 614-292-2622 | hall.611@osu.edu | |
Contact: Purnima Kumar, PhD,DDS | 614-804-2112 | kumar.83@osu.edu |
United States, Ohio | |
The Ohio State University Wexner Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: David L Hall, DDS 614-292-2622 hall.611@osu.edu | |
Contact: Purnima Kumar, PhD,DDS 614-804-2112 kumar.83@osu.edu |
Study Director: | David L Hall, DDS | The Ohio State University College of Dentistry |
Publications:
Responsible Party: | David Hall, Associate Professor, Hospital Attending, Ohio State University |
ClinicalTrials.gov Identifier: | NCT04603794 |
Other Study ID Numbers: |
2020H0346 |
First Posted: | October 27, 2020 Key Record Dates |
Last Update Posted: | October 27, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | As per The Ohio State University Office for Responsible Research Practices (Human Studies IRB) |
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 |
Mouthwashes COVID-19 Salivary Carriage |
Povidone-Iodine PCR (Polymerase Chain Reaction) Dental Aerosols |
Chlorhexidine Chlorhexidine gluconate Povidone-Iodine Hydrogen Peroxide Povidone Anti-Infective Agents, Local |
Anti-Infective Agents Disinfectants Dermatologic Agents Plasma Substitutes Blood Substitutes |