- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05239598
Povidone-Iodine Oral Rinse Study
A Phase II, Randomized Trial to Test the Effect of Povidone-iodine 0.5% as Mouthwash/Gargle on SARS-CoV-2 Load (COVID 19) as an Adjuvant Infection Control Measure in Dental Practice
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able and willing to provide informed consent prior to initiation of study procedures.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 years and older.
- Clinical diagnosis of COVID-19 infection confirmed with a positive point of care test.
- Confirmed diagnosis within 5 days of baseline visit (within 5 days of COVID-19 test) and at least one clinical COVID-19 symptom [*Signs and symptoms of COVID-19 present at illness onset vary, but over the course of the disease, most people will experience the following: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste of smell, sore throat, congestion or runny nose, nausea or vomiting and diarrhea.]
- Presents with a minimum of six natural teeth.
- Ability to rinse/gargle with study products.
- Not using mouth rinse/gargling solutions at the time of enrollment.
- Not taking antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment.
- Ability to participate in the study and come to site during Phase I of the study for collection of swabs and saliva.
- Willing to use an acceptable method of birth control throughout duration of the study. Acceptable methods include hormonal contraceptives, barrier methods, abstinence, or other effective methods approved by the PI.
- If continuing to Phase II of the trial, ability to continue using study products for 1 week (+ 3 days). (Participants do not have to agree to participate in Phase II in order to participate in Phase I.)
- If continuing to Phase II of the trial, agree to receive text messages/phone calls containing questionnaires regarding compliance and use of study product, and reminders, able to complete virtual follow-up study visit for collection of outcomes data.
Exclusion Criteria:
- Individuals receiving antiviral medications
- Pregnant or breastfeeding women (for premenopausal women of childbearing potential, pregnancy status to be confirmed through a urine pregnancy test during the study visit)
- Inability to comply with study protocol
- Having an allergy to any of the study mouthwash ingredients
- Having any thyroid condition.
- Presents with a current suspicious oral lesion at the examiner's discretion, and/or currently undergoing radiation therapy for head or neck cancer, and/or has received radiation therapy to the head or neck (including radioactive iodine therapy).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Povidone-iodine 0.5% antiseptic mouth rinse
Subjects will be asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds.
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Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
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Placebo Comparator: Placebo
Subjects will be asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds.
|
Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[PCR Saliva] Percent Change From Baseline Ct Viral Targets
Time Frame: 60 minutes after intervention
|
The primary endpoint is the percentage reduction of SARS-Co-V-2 load in saliva at 60 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash. For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load. A positive percent change from baseline Cycle Threshold indicates a decrease from baseline SAR-Co-V2. [Quick SARS-CoV-2 rRT-PCR Kit (Zymo Research, Cat. No. R3011)]. |
60 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention
Time Frame: 5 and 30 minutes post-intervention
|
The secondary endpoints are the percentage reduction of SARS-Co-V-2 load in saliva at 5 and 30 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash.
For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load.
A positive percent change from baseline Cycle Threshold indicated a decrease from baseline SARS-Co-V-2.
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5 and 30 minutes post-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens
Time Frame: 5, 30, and 60 minutes post intervention
|
The secondary endpoints are the percentage reduction in SARS-Co-V-2 antigens obtained from oropharyngeal swab at 5, 30 and 60-minutes (post-intervention) compared to baseline within each treatment group.
|
5, 30, and 60 minutes post intervention
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[Nasal Swab] Log10 Antigens
Time Frame: 5, 30, 60 minutes post intervention
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In the context of the study, the antigen data was used to validate infectivity, as this site was not treated.
The pre-specified outcomes are the percentage reduction in SARS-Co-V-2 antigens obtained from nasal swab at 5, 30 and 60-minutes (post-intervention) compared to baseline within each treatment group.
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5, 30, 60 minutes post intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia Corby, DDS, MS, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 849386
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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