ClinicalTrials.Veeva

Menu

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

Q

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

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

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

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems