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Povidone-Iodine Oral Rinse Study

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mouth rinse
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able and willing to provide informed consent prior to initiation of study procedures.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male or female, aged 18 years and older.
  4. Clinical diagnosis of COVID-19 infection confirmed with a positive point of care test.
  5. 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.]
  6. Presents with a minimum of six natural teeth.
  7. Ability to rinse/gargle with study products.
  8. Not using mouth rinse/gargling solutions at the time of enrollment.
  9. Not taking antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment.
  10. Ability to participate in the study and come to site during Phase I of the study for collection of swabs and saliva.
  11. 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.
  12. 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.)
  13. 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:

  1. Individuals receiving antiviral medications
  2. Pregnant or breastfeeding women (for premenopausal women of childbearing potential, pregnancy status to be confirmed through a urine pregnancy test during the study visit)
  3. Inability to comply with study protocol
  4. Having an allergy to any of the study mouthwash ingredients
  5. Having any thyroid condition.
  6. 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).

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Povidone-iodine 0.5% antiseptic mouth rinse

Placebo

Arm Description

Subjects will be asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds.

Subjects will be asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds.

Outcomes

Primary Outcome Measures

[PCR Saliva] Percent Change From Baseline Ct Viral Targets
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)].

Secondary Outcome Measures

[PCR Saliva] Percent Change From Baseline Cycle Threshold at 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.

Full Information

First Posted
February 14, 2022
Last Updated
July 20, 2023
Sponsor
University of Pennsylvania
Collaborators
This study was funded by an Investigator Initiated Research grant from Avrio Health L.P
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1. Study Identification

Unique Protocol Identification Number
NCT05239598
Brief Title
Povidone-Iodine Oral Rinse Study
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
This study was funded by an Investigator Initiated Research grant from Avrio Health L.P

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a two-arm, randomized, 2-phase study. Phase I will be double blinded clinical trial of the safety and efficacy of an antiseptic mouthwash solution on reducing SARS-CoV-2 load in COVID 19+ adult individuals. Phase II is designed as an open label trial, and all subjects will receive the active mouthwash.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Povidone-iodine 0.5% antiseptic mouth rinse
Arm Type
Experimental
Arm Description
Subjects will be asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds.
Intervention Type
Drug
Intervention Name(s)
Mouth rinse
Intervention Description
Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
Primary Outcome Measure Information:
Title
[PCR Saliva] Percent Change From Baseline Ct Viral Targets
Description
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)].
Time Frame
60 minutes after intervention
Secondary Outcome Measure Information:
Title
[PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention
Description
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.
Time Frame
5 and 30 minutes post-intervention
Other Pre-specified Outcome Measures:
Title
[Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens
Description
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.
Time Frame
5, 30, and 60 minutes post intervention
Title
[Nasal Swab] Log10 Antigens
Description
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.
Time Frame
5, 30, 60 minutes post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Corby, DDS, MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Povidone-Iodine Oral Rinse Study

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