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

Queen Mary University of London

Status: Completed

Conditions: Covid19; Coronavirus

Treatments: Other: No rinsing; Drug: Colgate Peroxyl® -1.5% Hydrogen peroxide; Other: Oral-B® Gum & Enamel Care -Cetylpyridinium chloride; Drug: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04723446

TBC

Details and patient eligibility

About

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).

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate

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

Experimental group

Description:

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

Treatment:

Drug: Colgate Peroxyl® -1.5% Hydrogen peroxide

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

Experimental group

Description:

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

Treatment:

Other: Oral-B® Gum & Enamel Care -Cetylpyridinium chloride

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

Experimental group

Description:

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

Treatment:

Other: No rinsing