Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19)

NCT04409873 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-11-18

Study results available
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Summary

In this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5 groups: distilled water, CloSYS Ultra Sensitive Rinse (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine Zero (Johnson and Johnson, USA).

Study participants will be asked to rinse/gargle with 10-20ml (according to the rinse instructions) of the assigned solutions 4 times per day, for 30-60 seconds, for 4 weeks.

Conditions

  • COVID-19
  • SARS-CoV 2
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Virus Disease
  • Coronavirus Infections
  • Pharyngeal Diseases

Interventions

DRUG

Oral-B Mouth Sore mouthwash

Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.

DRUG

Crest Pro-Health Multi-Protection mouthwash

Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.

DRUG

CloSYS Ultra Sensitive Rinse mouthwash

Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.

DRUG

Distilled water

Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.

DRUG

Listerine Zero Mouthwash Product

Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Stuart A Gansky, DrPH · Professor and Lee Hysan Chair of Oral Epidemiology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-09-10
Completion
2022-09-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04409873 on ClinicalTrials.gov