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[COVID-19] Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse

Primary Purpose

Covid19

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water (E) Mouth rinse with the solution provided
Chlorhexidine gluconate (A) Mouth rinse with the solution provided
Hydrogen peroxide (B) Mouth rinse with the solution provided
Betadine (C) Mouth rinse with the solution provided
Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution provided
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject of both sexes, aged 18 years or older
  2. Patients who are confirmed positive for COVID-19.
  3. Patients currently hospitalized at Augusta University Medical Center.
  4. Subject voluntarily signing the informed consent document.

Exclusion Criteria:

  1. Age younger than 18 years old.
  2. Patients that are tested negative for COVID-19
  3. Patient who are intubated or too sick to give consent for the study.
  4. Not able to speak in English or illiterate or lacking the decision-making capacity to consent for study.
  5. Known allergy to Listerine, Betadine or Chlorhexidine gluconate

Sites / Locations

  • Augusta University
  • Augusta University-Dental College of Georgia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Chlorhexidine gluconate (A)

Hydrogen peroxide (B)

Betadine (C)

Mouth wash (D)

Water (E)

Arm Description

Mouth rinse with 0.2% Chlorhexidine gluconate,

Mouth rinse with 1.5% hydrogen peroxide

Mouth rinse with betadine mouthwash,

Mouth rinse with alcohol-based mouthwash

Mouth rinse with water

Outcomes

Primary Outcome Measures

Change in oral SARS-CoV-2 load in oral cavity of COVID-19 patient using prophylactic mouth rinse

Secondary Outcome Measures

Full Information

First Posted
October 21, 2020
Last Updated
January 31, 2022
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT04719208
Brief Title
[COVID-19] Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse
Official Title
Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test the effectiveness of prophylactic mouth rinses in reducing the amount of viruses, specifically SARS-CoV-2 in the oral cavity. This research will guide dental and medical providers on best practices to be performed prior to dental and medical procedures involving the oral cavity.
Detailed Description
In response to SARS-CoV-2 the dental and greater healthcare communities have devised ways to combat the spread of the virus. Many dentists and physicians have advocated the use of prophylactic oral rinses for reduction of COVID-19 viral load in all patients prior to treatment in the oral pharyngeal cavity, but the effectiveness of these measures has not been validated with empirical evidence. The investigators will test COVID-19 positive hospital inpatients before and after the use of different combinations of oral rinses to provide guidance on best measures for dental or medical treatment. This research is imperative and essential as prophylactic rinses are already being used at AU and globally, without data to support their effectiveness specifically in COVID-19 positive patients. Oral rinses have been used as an industry standard in dentistry for decades to reduce oral levels of pathogens including bacteria and viruses. According to the American Academy of Dentistry mouth rinses can be broken down into two categories, cosmetic and therapeutic. Those categorized as therapeutic include chlorhexidine, essential oils, fluoride, and hydrogen peroxide. These rinses are routinely used in both dental practices as well as in the OR setting prior to any invasive procedure involving treatment of the oral cavity. However, these mouth rinses, are typically utilized to reduce risk of infection to the patient. By disinfecting the oral cavity through bacteriostatic, bactericidal, and virucidal rinses practitioners can mitigate the risk of spreading an infection from a patient's mouth or the outside environment to other parts of their body. Prophylactic rinses are often used prior to routine dental procedures like fillings and cleaning to more invasive interventions like jaw reconstruction and tumor resection. This simple, cheap and innocuous procedure is now being used for a different purpose. In light of the COVID-19 pandemic, reduction in the spread of oral and respiratory borne viruses has become paramount in the global battle against coronavirus. Both dentists and medical providers, including ear nose throat specialists and anesthesiologists who routinely intubate patients, have implemented the use of these virucidal mouth rinses to reduce viral loads of both COVID-19 positive and non-infected patients. Dentists are particularly at risk for transmission of COVID-19 because they work directly in the oral cavity where the virus resides and the work they do creates an enormous amount of aerosols. In addition to a multitude of barrier and personal protective equipment (PPE) techniques being implemented, prior to procedures in the oral cavity patients are asked to rinse and spit different regimens of mouth rinses to reduce the chance of spreading SARS-CoV-2 to healthcare staff. While healthcare workers have had to act quickly to respond to the pandemic and reduce the risk of spreading coronavirus, there is a lack of empirical evidence to support current practices. Here the investigators aim to address three questions; 1: Does oral prophylaxis effectively reduce oral viral load specifically of SARS-CoV-2; 2: If so for what duration is oral prophylaxis effective before viral load recovers in the oral cavity; 3: Which combination of virucidal prophylaxis if any is most effective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine gluconate (A)
Arm Type
Experimental
Arm Description
Mouth rinse with 0.2% Chlorhexidine gluconate,
Arm Title
Hydrogen peroxide (B)
Arm Type
Experimental
Arm Description
Mouth rinse with 1.5% hydrogen peroxide
Arm Title
Betadine (C)
Arm Type
Experimental
Arm Description
Mouth rinse with betadine mouthwash,
Arm Title
Mouth wash (D)
Arm Type
Experimental
Arm Description
Mouth rinse with alcohol-based mouthwash
Arm Title
Water (E)
Arm Type
Placebo Comparator
Arm Description
Mouth rinse with water
Intervention Type
Other
Intervention Name(s)
Water (E) Mouth rinse with the solution provided
Intervention Description
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
Intervention Type
Other
Intervention Name(s)
Chlorhexidine gluconate (A) Mouth rinse with the solution provided
Intervention Description
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
Intervention Type
Other
Intervention Name(s)
Hydrogen peroxide (B) Mouth rinse with the solution provided
Intervention Description
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
Intervention Type
Other
Intervention Name(s)
Betadine (C) Mouth rinse with the solution provided
Intervention Description
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
Intervention Type
Other
Intervention Name(s)
Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution provided
Intervention Description
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
Primary Outcome Measure Information:
Title
Change in oral SARS-CoV-2 load in oral cavity of COVID-19 patient using prophylactic mouth rinse
Time Frame
up to 2 hours post-rinse with mouthwash.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject of both sexes, aged 18 years or older Patients who are confirmed positive for COVID-19. Patients currently hospitalized at Augusta University Medical Center. Subject voluntarily signing the informed consent document. Exclusion Criteria: Age younger than 18 years old. Patients that are tested negative for COVID-19 Patient who are intubated or too sick to give consent for the study. Not able to speak in English or illiterate or lacking the decision-making capacity to consent for study. Known allergy to Listerine, Betadine or Chlorhexidine gluconate
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Augusta University-Dental College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

[COVID-19] Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse

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