Povidone-Iodine Oral Rinse Study

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239598
• Other study ID #: 849386
• Status: Completed
• Phase: Phase 2
• Start date: February 7, 2022
• Est. completion date: July 13, 2022

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 13, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	This study was funded by an Investigator Initiated Research grant from Avrio Health L.P

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	[Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens	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
Other	[Nasal Swab] Log10 Antigens	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.	5, 30, 60 minutes post intervention
Primary	[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	[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.	5 and 30 minutes post-intervention