Efficacy of Mouthwashes in Reducing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load in the Saliva (COVID-19)

September 12, 2023 updated by: Queen Mary University of London

Efficacy of Three Antimicrobial Mouthwashes in Reducing SARS-CoV-2 Viral Load in the Saliva of Patients Diagnosed With COVID-19: A Pilot Study

This is a single-blind, parallel-group, randomized pilot study designed to evaluate and compare the efficacy of 3 different mouthwashes containing 0.2% Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride in reducing Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in the saliva of COVID-19 positive patients at different time-points.

A convenient sample of up to 40 COVID-19 positive patients diagnosed via test and/or presenting COVID-19 clinical symptoms will be identified in the inpatients and/or outpatient clinics at the Newham University Hospital and at The Royal London Hospital, Barts Health National Health Service (NHS) Trust, United Kingdom (UK).

The study will consist of one visit. Unstimulated saliva samples will be collected from all COVID-19 positive patients before and at 30 minutes, 1, 2, and 3 hours after mouth rinsing (Group 1-3 ) or no rinsing (Group 4). Viral load analysis of saliva samples in the different time-points will be then assessed by Reverse Transcription quantitative PCR (RT- qPCR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Royal London Hospital
      • London, United Kingdom
        • Newham Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

All of the following criteria must be fulfilled for inclusion:

  • Patients must have willingness to read and sign a copy of Informed Consent Form.
  • Males and females, ≥ 18 years old.
  • COVID-19 positive patients confirmed via any diagnostic test and/or presented with COVID-19 clinical symptoms at point of consent.

Exclusion criteria for patients

Patients presenting with any of the following will not be included in the trial:

  • Known pre-existing chronic mucosal lesions e.g. lichen planus or other oropharyngeal lesions, reported by patient or recorded in the existing patient' medical notes;
  • Patients currently intubated or not capable of mouth rinse or spit;
  • History of head and neck radiotherapy or chemotherapy;
  • Self-reported xerostomia;
  • Known allergy or hypersensitivity to chlorhexidine digluconate or one of the mouthwashes constituents;
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial;
  • Inability to comply with study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate
Participants will be instructed to rinse their mouth with 10 ml of Corsodyl® Alcohol free mouthwash for 1 minute.
Drug: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate
Corsodyl® Alcohol-free is a clear to slightly opalescent oromucosal solution with an odour of peppermint that contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common oral conditions.
Experimental: Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide
Participants will be instructed to rinse their mouth with 10 ml of Colgate® Peroxyl mouthwash for 1 minute.
Drug: Colgate Peroxyl® -1.5% Hydrogen peroxide
Peroxyl mouthwash is a clear aqua-blue liquid oromucosal solution which 100ml of solution contains 1.5g of Hydrogen peroxide (as 30% Hydrogen Peroxide solution). It is an oral antiseptic cleanser for external use. The principal action is brought about by contact of hydrogen peroxide with peroxidases and catalases present in tissues and saliva, which causes the rapid release of oxygen. This provides mechanical cleansing which flushes out mouth debris and helps in the treatment of oral irritations. This mouthwash is used as a cleanser in the symptomatic relief of minor mouth and gum irritations.
Experimental: Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride
Participants will be instructed to rinse their mouth with 10 ml of Oral-B® Gum & Enamel Care mouthwashes for 1 minute.
Other: Oral-B® Gum & Enamel Care -Cetylpyridinium chloride
The Oral-B® Gum & Enamel Care mouthwash is an oromucosal solution containing Cetylpyridinium chloride (CPC) and used as an adjunct to oral hygiene.
Other Names:
  • Cosmetic product
Experimental: Group 4 (control group; n= up to 10 patients) - No rinsing
Patients will be instructed to not rinse their mouth with any solution, not even water.
Other: No rinsing
No rinsing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral load changes in the saliva within groups
Time Frame: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.
Viral load changes in the saliva of COVID-19 positive patients assessed by RT-qPCR assays at 30 minutes, 1, 2 and 3 hours after mouth rinsing with a mouthwash containing 0.2 % Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride compared to baseline.
30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the viral load changes in the saliva between groups
Time Frame: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.
Difference in the viral load changes in the saliva of COVID-19 positive patients assessed by RT-qPCR assays, at the different study time-points, between groups 0.2 % Chlorhexidine digluconate, 1.5% Hydroxide peroxide, Cetylpyridinium chloride mouthwash and no rinsing (control).
30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Prof Nikos Donos, PhD, Queen Mary University London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Actual)

October 25, 2021

Study Completion (Actual)

October 25, 2021

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBC (TBC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregated/collective data regarding the efficacy of the different mouthwashes will be shared with the scientific community as a de-identified/coded information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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