Status:
TERMINATED
Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Rowpar Pharmaceuticals, Inc.
Conditions:
COVID-19
SARS-CoV 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (...
Detailed Description
SARS-CoV-2, the virus causing COVID-19, has affected vulnerable individuals, especially those with comorbidities, and high exposure health care workers (HCWs). Typically, the virus first colonizes in ...
Eligibility Criteria
Inclusion
- Tested positive for COVID-19 with a sample collected in the prior 7 days
- Ability to read and speak English or Spanish
- Ability to participate in the study for 4 weeks
- Being asymptomatic or having mild or moderate symptoms (for example, sore throat, coughing, fever, fatigue)
- Ability to rinse/gargle
- Not having any condition that might worsen with gargling solutions
- Not having a history of mouthwash sensitivity
- Not having an allergy to any mouthwash that has been used before
- Not using another mouthwash/gargling solution since the most recent positive test
- Not taking antimicrobial medications (antibacterial, antiviral, antibiotics including off-label FDA-approved medications such as hydroxychloroquine)
- Anticipated ability to participate in the study for 4 weeks
- Have a cellphone and agree to receive text messages for reminders to use mouthwash during the day and for follow-up visits, and can videoconference (like zoom) on a cellphone, tablet, or computer for sample collection instructions
Exclusion
- People who because of their symptoms intend to receive antiviral medications that could potentially affect viral load in their saliva samples
- Pregnant or lactating women due to potential aversions to mouthwash solution taste/smell.
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04409873
Start Date
March 31 2021
End Date
September 10 2022
Last Update
November 18 2023
Active Locations (1)
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1
University Of California, San Francisco
San Francisco, California, United States, 94143