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Mouth Rinses for Inactivation of COVID-19

NCT04584684 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-03-25

Study results available
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Summary

Randomized, double-blind prospective trial to test the efficacy and acceptability of therapeutic, antiseptic mouth rinses to inactivate severe acute respiratory syndrome coronavirus (SARS-CoV-2) in saliva of COVID-19 positive patients aged 18-65 years old. All mouthrinses are commercially available and will be used according to on-label instructions. Patients will be randomized to a mouthrinse and will be asked to give a saliva sample immediately before and after a one minute mouthwash. Saliva samples will be collected from patients at 15 minute intervals thereafter up to an hour (15, 30, 45 and 60 minutes). The samples will be stored and used for real-time reverse transcription polymerase chain reaction (RT-PCR) detection of viral SARS-CoV-2 RNA and viral infectivity assays. Patients will also complete a short-survey on the taste and experience of using the mouthwash. This study involves 480 subject participants and one, 75-90 minute visit.

Conditions

Interventions

OTHER

0.9% w/v NaCL Saline

saline placebo rinse

DRUG

1.5% w/v Hydrogen Peroxide

Over-the-counter antiseptic mouth rinse

DRUG

0.12% Chlorohexidine Gluconate

Dentist prescribed antimicrobial mouth rinse

DRUG

27% Ethanol plus essential oils

Over-the-counter antiseptic mouth rinse

DRUG

0.5% w/v Povidone-iodide

Over-the-counter antiseptic mouth rinse

DRUG

0.075% Cetylpyridinium Chloride

Over-the-counter antiseptic mouth rinse

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Laura Jacox, DMD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2021-10-21
Completion
2021-10-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04584684 on ClinicalTrials.gov