Mouth Rinses for Inactivation of COVID-19 (MOR)
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ClinicalTrials.gov Identifier: NCT04584684 |
Recruitment Status :
Terminated
(The team decided to terminate the trial in order to start a new trial, unrelated to safety reasons)
First Posted : October 14, 2020
Results First Posted : March 25, 2024
Last Update Posted : March 25, 2024
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Tracking Information | |||||||||||
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First Submitted Date ICMJE | October 9, 2020 | ||||||||||
First Posted Date ICMJE | October 14, 2020 | ||||||||||
Results First Submitted Date ICMJE | January 27, 2023 | ||||||||||
Results First Posted Date ICMJE | March 25, 2024 | ||||||||||
Last Update Posted Date | March 25, 2024 | ||||||||||
Actual Study Start Date ICMJE | December 18, 2020 | ||||||||||
Actual Primary Completion Date | October 21, 2021 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Descriptive Information | |||||||||||
Brief Title ICMJE | Mouth Rinses for Inactivation of COVID-19 | ||||||||||
Official Title ICMJE | Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus | ||||||||||
Brief 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. | ||||||||||
Detailed Description | Consenting Procedure Patients will be contacted first by phone and, if not available, then by email. Interested patients will make an appointment to visit the GO Health Clinical Research Unit at Adams School of Dentistry for this study. Study participation includes only one visit. For Spanish speaking patients and/or parents, Spanish forms will be provided and communication will occur through a Spanish translator. All patients are adults and over normal cognitive capacity, and therefore will be able to consent for themselves. Screening
Enrollment, Baseline, and/or Randomization Outpatient subjects will be recruited from patients seen in the UNC Respiratory Distress Clinic (RDC) who have tested positive for COVID+ and consented to be contacted for participation in COVID-related research studies. The subjects being approached by phone or email have signed a prior facility consent at the Respiratory Distress Clinic confirming willingness to share their name and contact information to be contacted for study participation in COVID related research. Investigators will not receive information on subjects that decline this internal consent. Subjects will be contacted for recruitment by phone and (if unreachable by phone) by secure email by study personnel; patients will have the study rationale and risks explained and will be provided time to ask questions and consider participation. If patients are interested in participating, a single appointment will be scheduled for them at the Adams School of Dentistry GO Health Clinical research core. Consent documentation will be signed in person and in private in the GO Health Clinical Research Core. A list of COVID+ subjects that have consented to be contacted for research, will be provided by the RDC clinic, sent via secure University of North Carolina (UNC) at Chapel Hill NC servers or secure UNC email to the research team's clinical coordinator, and this list will include names and contact details (PHI). This list is updated daily and provided to approved research sites.. Randomization The study statistician will create a block randomization schedule and perform these computations. The researcher in charge of collecting the salivary samples will be blinded to the mouthwash solution, as they will be given a pre-aliquoted mouthrinse in an unlabeled storage tube to provide to the patient for the rinse. Blinding Subjects will be provided with an unlabeled/blinded mouthrinse. The researcher in charge of collecting the salivary samples will be blinded to the mouthwash solution as well, as they will be given a pre-aliquoted mouthrinse in an unlabeled storage syringe to provide to the patient for the rinse. The study statistician will set up a block randomization schedule that the team will abide by for assignment of enrolled subjects. Follow-up Visits This study requires only one 70-90 minute, single visit appointment. No diagnostic tests will be run as part of this clinical trial. All participants will already have known COVID+ status, and therefore no follow-up reporting is needed. Completion/Final Evaluation This study requires only one 70-90 minute, single visit appointment. Subjects will be asked to rinse with an unlabeled/blinded antiviral mouth rinse for 60 seconds and provide 5 mL of saliva prior to the rinse and 2 mL of saliva immediately post-rinse, 15 minutes post-rinse, 30 minutes post-rinse, 45 minutes post-rinse, and 60 minutes post-rinse. Subjects will also be asked to complete a short survey about the rinsing experience. Subjects may withdraw from the trial at any time or they may be withdrawn at any time at the discretion of the Investigator or Sponsor for safety, behavioral or administrative reasons. |
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Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, placebo-controlled, double-blind prospective trial to test the efficacy and acceptability of 5 therapeutic, antiseptic mouth rinses to inactivate SARS-CoV-2 virus in saliva of COVID-19 positive patients. Masking: Triple (Participant, Care Provider, Outcomes Assessor)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||
Actual Enrollment ICMJE |
128 | ||||||||||
Original Estimated Enrollment ICMJE |
480 | ||||||||||
Actual Study Completion Date ICMJE | October 21, 2021 | ||||||||||
Actual Primary Completion Date | October 21, 2021 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||
Listed Location Countries ICMJE | United States | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT04584684 | ||||||||||
Other Study ID Numbers ICMJE | 20-2040 | ||||||||||
Has Data Monitoring Committee | No | ||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University of North Carolina, Chapel Hill | ||||||||||
Original Responsible Party | Same as current | ||||||||||
Current Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||
Collaborators ICMJE | Not Provided | ||||||||||
Investigators ICMJE |
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PRS Account | University of North Carolina, Chapel Hill | ||||||||||
Verification Date | February 2024 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |