Povidone-Iodine Oral Rinse Study

NCT05239598 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 849386
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• [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. \[Quick SARS-CoV-2 rRT-PCR Kit (Zymo Research, Cat. No. R3011)\].

  60 minutes after intervention

Secondary Outcomes (1)

• [PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention

  5 and 30 minutes post-intervention

Other Outcomes (2)

• [Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens

  5, 30, and 60 minutes post intervention

• [Nasal Swab] Log10 Antigens

  5, 30, 60 minutes post intervention

Study Arms (2)

Povidone-iodine 0.5% antiseptic mouth rinse

EXPERIMENTAL

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

Drug: Mouth rinse

Placebo

PLACEBO COMPARATOR

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

Drug: Mouth rinse

Interventions

Mouth rinse DRUG

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

Placebo; Povidone-iodine 0.5% antiseptic mouth rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pennsylvania: lead
• Avrio Health: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Our findings suggest that RT-PCR quantification of Ct viral targets present some limitations but can be of clinical utility. RT-PCR methods are inherently quantitative, and reproducible during repeated clinical sampling over a short time period. A limitation of our study was that changes in viral targets (RT-PCR) was determined after a one-time use of the mouthwash; prolonged use might yield better efficacy.

Results Point of Contact

• Title: Dr. Pat Corby
• Organization: Penn Dental Medicine

patcorby@upenn.edu

215-898-1162

Study Officials

• Patricia Corby, DDS, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 15, 2022
• Study Start: February 7, 2022
• Primary Completion: July 7, 2022
• Study Completion: July 13, 2022
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)