Povidone-Iodine Oral Rinse Study
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Mouth rinse
Intervention description: Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).