Clinical trial NCT05239598: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Avrio Health
First posted: 2022-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: [PCR Saliva] Percent Change From Baseline Ct Viral Targets
timeFrame: 60 minutes after intervention
Secondary outcomes:
measure: [PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention
timeFrame: 5 and 30 minutes post-intervention
Other outcomes:
measure: [Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens
timeFrame: 5, 30, and 60 minutes post intervention
measure: [Nasal Swab] Log10 Antigens
timeFrame: 5, 30, 60 minutes post intervention
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Patricia Corby, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: