Clinical trial NCT04723446: Efficacy of Mouthwashes in Reducing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load in the Saliva
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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Coronavirus
Keywords: Mouthwash
Chlorhexidine digluconate
Hydroxide peroxide
Cetylpyridinium chloride
Viral load
SARS-CoV-2
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2021-01-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


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.

Primary outcomes:
measure: Viral load changes in the saliva within groups
timeFrame: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.
Secondary outcomes:
measure: Difference in the viral load changes in the saliva between groups
timeFrame: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Newham Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: Queen Mary University London
name: Prof Nikos Donos, PhD
role: PRINCIPAL_INVESTIGATOR
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