Mouth Rinses for Inactivation of COVID-19 : Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus
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.ScreeningAt the visit, a consented patient will answer screening questions regarding inclusion and exclusion criteria. Answers will be entered into the Carolina Data Acquisition and Reporting Tool (CDART) research database managed by UNC.Prior to finalizing these screening questions, women participants of childbearing potential will be asked to provide a urine sample in the restroom, to undergo a rapid pregnancy test by study personnel. Any pregnant or lactating patients will be excluded.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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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 25. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: October 14, 2020, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 |
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| PPN (Katalog-ID): |
CTG000164011 |
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| 520 | |a 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.ScreeningAt the visit, a consented patient will answer screening questions regarding inclusion and exclusion criteria. Answers will be entered into the Carolina Data Acquisition and Reporting Tool (CDART) research database managed by UNC.Prior to finalizing these screening questions, women participants of childbearing potential will be asked to provide a urine sample in the restroom, to undergo a rapid pregnancy test by study personnel. Any pregnant or lactating patients will be excluded.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. | ||
| 650 | 2 | |a Infections | |
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| 650 | 2 | |a COVID-19 | |
| 650 | 2 | |a Coronavirus Infections | |
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| 650 | 4 | |a Recruitment Status: Terminated | |
| 650 | 4 | |a Phase: Phase 2 | |
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