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NCT04748783 · ClinicalTrials.gov registry record · Phase 2
Antiviral Efficacy and Acceptability of 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
- 2
- Enrollment target
NCT04748783 is a Phase 2 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 2 participants.
The verdict
NCT04748783, a Phase 2 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Subjects (125) will be randomized to one of five mouthrinses and will be asked to give a saliva sample immediately before and after a 30-60 second mouthwash. Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva will be used for RT-PCR detection of Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex). Subjects will complete a short survey on the taste and experience of using the mouthwash. Peripheral blood will be collected at the end of salivary collection. Subjects, except controls, will be provided materials and oral hygiene instruction related to daily use of oral hygiene products. In the seven-day period between study visit one and study visit two, subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse with the Colgate mouthrinse (according to on-label procedures). Controls are asked to carry out their typical oral hygiene regimen with the products they typically use. All subjects keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures. Subjects complete study visit two one week after the baseline visit during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse) will occur and blood samples collected. each subject will undergo a periodontal exam.
Interventions
- OTHER Water
- OTHER Peroxyl
- DRUG Periogard
- OTHER Colgate Total Zero
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-03-26 |
| Est. Completion | 2021-04-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04748783
The ClinicalTrials.gov registry entry for NCT04748783 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Water is the first listed.
NCT04748783 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04748783 about?
NCT04748783 is a clinical study titled "Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19". Subjects (125) will be randomized to one of five mouthrinses and will be asked to give a saliva sample immediately before and after a 30-60 second mouthwash. Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva will be u...
What is the current status of trial NCT04748783?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2021-03-26. Estimated completion is 2021-04-07.
What interventions are being tested in trial NCT04748783?
The interventions under investigation include: Water (OTHER), Peroxyl (OTHER), Periogard (DRUG), Colgate Total Zero (OTHER).
Who is sponsoring clinical trial NCT04748783?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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