Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection

Phase 1

• Conditions: Covid19
• Interventions: Drug: Mouthwash Product; Other: Water rinse

• Registration Number: NCT04931004
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.

Detailed Description

The study will consist of a Control Phase to optimize procedures for measuring expelled/exhaled viral load, and a Evaluation phase comparing different commercially available mouthwashes.

In the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash.

Based on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-23
• Study Start: 2021-07
• Primary Completion: 2021-12
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Age ≥ 18
2. Able to provide consent
3. Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours.

Exclusion Criteria

1. Clinical contraindication or poor feasibility to complete study procedures
2. Unwilling or unable to produce saliva or face mask samples
3. Unable to produce at least 500 microliters of saliva.
4. Eaten within past 30 minutes
5. Known allergy to mouthwash products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.075% Cetylpyridinium Chloride	Mouthwash Product	-
1.5% Hydrogen peroxide	Mouthwash Product	-
Chlorhexidine gluconate	Mouthwash Product	-
Water rinse	Water rinse	Control for impact on viral load changes from mechanical rinsing

Primary Outcome Measures

Name	Time	Method
Control Phase - Primary Endpoint	Single timepoint, ~1 hour	Reduction in viral load by face mask sampling from pre-intervention to 0-15 with CPC versus water rinse control
Evaluation Phase - Primary Endpoint	Single timepoint, ~1.5 hours	Reduction in viral load by face mask sampling from pre-intervention to 45-60 minutes versus water rinse control

Secondary Outcome Measures

Name	Time	Method
Evaluation Phase - Secondary Endpoint	Single timepoint, ~1 hour	Reduction in viral load by face mask sampling from pre-intervention to 0-15 and15-30 minutes of oral rinse products versus water rinse control
Comparative Saliva Reduction	Single timepoint, ~1.5 hours	Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.