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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
Sponsor:
Information provided by (Responsible Party):
David Hall, Ohio State University

Brief Summary:
Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of individuals who exhibit signs of the disease. Investigators would like to test the ability of three mouthwashes to reduce the levels of this virus in participants' mouths. Investigators will ask participants to use a liquid to swish around in the mouth for 30 seconds and spit it into a collection cup. Investigators will also collect spit from participants before and after participants use the mouthwash. Although participants will have no direct benefits from the study, investigators will gain a wealth of information that would benefit patients who are at risk for COVID-19.

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

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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




Primary Outcome Measures :
  1. 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

  2. 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
Criteria

Inclusion Criteria:

  1. adults age 18-80 admitted to The Ohio State University Medical Center,
  2. diagnosis of COVID-19 confirmed by Polymerase Chain Reaction (PCR),
  3. salivary carriage of COVID-19 virus
  4. ability to perform mouthwash rinses and to expectorate.

Exclusion Criteria:

  1. allergy to any study mouth rinse,
  2. active uncontrolled thyroid disease,
  3. pregnancy
  4. patients undergoing radioactive iodine therapy.

Information from the National Library of Medicine

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


Contacts
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Contact: David L Hall, DDS 614-292-2622 hall.611@osu.edu
Contact: Purnima Kumar, PhD,DDS 614-804-2112 kumar.83@osu.edu

Locations
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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   
Sponsors and Collaborators
Ohio State University
Investigators
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Study Director: David L Hall, DDS The Ohio State University College of Dentistry
Additional Information:
Publications:

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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)

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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
Keywords provided by David Hall, Ohio State University:
Mouthwashes
COVID-19
Salivary Carriage
Povidone-Iodine
PCR (Polymerase Chain Reaction)
Dental Aerosols
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Povidone-Iodine
Hydrogen Peroxide
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Plasma Substitutes
Blood Substitutes