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NCT04584684 · ClinicalTrials.gov registry record · Phase 2
Mouth Rinses for Inactivation of COVID-19
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT04584684: Clinical Trial Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT04584684 is a Phase 2 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 128 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04584684, a Phase 2 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study 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.
Primary Outcome
Determination of SARS-CoV-2 viral RNA in COVID+ patient saliva using Quantitative Polymerase Chain Reaction (qPCR).
Interventions
- OTHER 0.9% w/v NaCL Saline
- DRUG 1.5% w/v Hydrogen Peroxide
- DRUG 0.12% Chlorohexidine Gluconate
- DRUG 27% Ethanol plus essential oils
- DRUG 0.5% w/v Povidone-iodide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2021-10-21 |
| Phase | Phase 2 |
Why NCT04584684 stopped before completion
NCT04584684 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which 0.9% w/v NaCL Saline is the first listed.
NCT04584684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04584684 about?
NCT04584684 is a clinical study titled "Mouth Rinses for Inactivation of COVID-19". 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 ...
What is the current status of trial NCT04584684?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2020-12-18. Estimated completion is 2021-10-21.
What interventions are being tested in trial NCT04584684?
The interventions under investigation include: 0.9% w/v NaCL Saline (OTHER), 1.5% w/v Hydrogen Peroxide (DRUG), 0.12% Chlorohexidine Gluconate (DRUG), 27% Ethanol plus essential oils (DRUG), 0.5% w/v Povidone-iodide (DRUG).
Who is sponsoring clinical trial NCT04584684?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04584684's enrollment target sits among peer trials
128 553rd of 2000 higher than 1,446 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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