Covid19, Coronavirus
Conditions
Keywords
Mouthwash, Chlorhexidine digluconate, Hydroxide peroxide, Cetylpyridinium chloride, Viral load, SARS-CoV-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).
Interventions
DRUGCorsodyl® 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.
DRUGColgate 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.
OTHEROral-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.
OTHERNo rinsing
No rinsing
Sponsors
GlaxoSmithKline
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral load changes in the saliva within groups | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the viral load changes in the saliva between groups | 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). |
Countries
United Kingdom
Outcome results
None listed