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

Primary Purpose

Covid19, Coronavirus

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate

Colgate Peroxyl® -1.5% Hydrogen peroxide

Oral-B® Gum & Enamel Care -Cetylpyridinium chloride

No rinsing

About this trial

This is an interventional other trial for Covid19 focused on measuring Mouthwash, Chlorhexidine digluconate, Hydroxide peroxide, Cetylpyridinium chloride, Viral load, SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Newham Hospital
Royal London Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate

Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide

Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride

Group 4 (control group; n= up to 10 patients) - No rinsing

Arm Description

Participants will be instructed to rinse their mouth with 10 ml of Corsodyl® Alcohol free mouthwash for 1 minute.

Participants will be instructed to rinse their mouth with 10 ml of Colgate® Peroxyl mouthwash for 1 minute.

Participants will be instructed to rinse their mouth with 10 ml of Oral-B® Gum & Enamel Care mouthwashes for 1 minute.

Patients will be instructed to not rinse their mouth with any solution, not even water.

Outcomes

Primary Outcome Measures

Viral load changes in the saliva within groups

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.

Secondary Outcome Measures

Difference in the viral load changes in the saliva between groups

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).

Full Information

NCT ID

NCT04723446

First Posted

January 5, 2021

Last Updated

September 12, 2023

Sponsor

Queen Mary University of London

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT04723446

Brief Title

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

Acronym

COVID-19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

May 19, 2021 (Actual)

Primary Completion Date

October 25, 2021 (Actual)

Study Completion Date

October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Queen Mary University of London

Collaborators

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

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

Covid19, Coronavirus

Keywords

Mouthwash, Chlorhexidine digluconate, Hydroxide peroxide, Cetylpyridinium chloride, Viral load, SARS-CoV-2

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate

Arm Type

Experimental

Arm Description

Participants will be instructed to rinse their mouth with 10 ml of Corsodyl® Alcohol free mouthwash for 1 minute.

Arm Title

Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide

Arm Type

Experimental

Arm Description

Participants will be instructed to rinse their mouth with 10 ml of Colgate® Peroxyl mouthwash for 1 minute.

Arm Title

Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride

Arm Type

Experimental

Arm Description

Participants will be instructed to rinse their mouth with 10 ml of Oral-B® Gum & Enamel Care mouthwashes for 1 minute.

Arm Title

Group 4 (control group; n= up to 10 patients) - No rinsing

Arm Type

Experimental

Arm Description

Patients will be instructed to not rinse their mouth with any solution, not even water.

Intervention Type

Drug

Intervention Name(s)

Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Colgate Peroxyl® -1.5% Hydrogen peroxide

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Oral-B® Gum & Enamel Care -Cetylpyridinium chloride

Other Intervention Name(s)

Cosmetic product

Intervention Description

The Oral-B® Gum & Enamel Care mouthwash is an oromucosal solution containing Cetylpyridinium chloride (CPC) and used as an adjunct to oral hygiene.

Intervention Type

Other

Intervention Name(s)

No rinsing

Intervention Description

No rinsing

Primary Outcome Measure Information:

Title

Viral load changes in the saliva within groups

Description

Time Frame

30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.

Secondary Outcome Measure Information:

Title

Difference in the viral load changes in the saliva between groups

Description

Time Frame

30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof Nikos Donos, PhD

Organizational Affiliation

Queen Mary University London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Newham Hospital

City

London

Country

United Kingdom

Facility Name

Royal London Hospital

City

London

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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

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Links:

URL

https://pubmed.ncbi.nlm.nih.gov/37542087/

Description

Efficacy of three antimicrobial mouthwashes in reducing SARS-CoV-2 viral load in the saliva of hospitalized patients: a randomized controlled pilot study

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

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