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
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
-
Rowpar Pharmaceuticals, Inc.
collaborator INDUSTRY -
University of California, San Francisco
lead OTHER
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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