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

NCT04723446 | Completed DMC

• 1 other identifier: TBC
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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).

Conditions

Covid19; Coronavirus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Difference in the viral load changes in the saliva between groups

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

Study Arms (4)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Other: No rinsing

Interventions

Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate DRUG

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.

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

Colgate Peroxyl® -1.5% Hydrogen peroxide DRUG

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.

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

Oral-B® Gum & Enamel Care -Cetylpyridinium chloride OTHER

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

Also known as: Cosmetic product

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

No rinsing OTHER

No rinsing

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

Newham Hospital

London, United Kingdom

Location

Royal London Hospital

London, United Kingdom

Location

Related Publications (25)

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  PMID: 37542087 RESULT

Related Links

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

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Ethanol; Cosmetics

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Prof Nikos Donos, PhD

  Queen Mary University London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 25, 2021
• Study Start: May 19, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: September 14, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)