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

Not Applicable

Completed

• Conditions: Covid19; Coronavirus
• Interventions: Drug: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate; Other: Oral-B® Gum & Enamel Care -Cetylpyridinium chloride; Drug: Colgate Peroxyl® -1.5% Hydrogen peroxide; Other: No rinsing

• Registration Number: NCT04723446
• Lead Sponsor: Queen Mary University of London

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-25
• Study Start: 2021-05-19
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Status Verified: 2021-11
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate	Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate	Participants will be instructed to rinse their mouth with 10 ml of Corsodyl® Alcohol free mouthwash for 1 minute.
Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride	Oral-B® Gum & Enamel Care -Cetylpyridinium chloride	Participants will be instructed to rinse their mouth with 10 ml of Oral-B® Gum \& Enamel Care mouthwashes for 1 minute.
Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide	Colgate Peroxyl® -1.5% Hydrogen peroxide	Participants will be instructed to rinse their mouth with 10 ml of Colgate® Peroxyl mouthwash for 1 minute.
Group 4 (control group; n= up to 10 patients) - No rinsing	No rinsing	Patients will be instructed to not rinse their mouth with any solution, not even water.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Newham Hospital; 🇬🇧 London, United Kingdom

Royal London Hospital; 🇬🇧 London, United Kingdom