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Povidone-Iodine Oral Rinse Study

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ClinicalTrials.gov Identifier: NCT05239598
Recruitment Status : Recruiting
First Posted : February 15, 2022
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Mouth rinse Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : February 7, 2022
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Povidone-iodine 0.5% antiseptic mouth rinse
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
Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
Placebo Comparator: Placebo
Subjects will be asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds.
 Drug: Mouth rinse
Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.


Outcome Measures
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Primary Outcome Measures :
  1. Change in viral load in oral cavity [ Time Frame: 5 minutes, 30 minutes, 60 minutes after intervention ]
    The primary outcome is the change in amount of SARS-CoV-2 in the oral cavity before and after intervention.


Secondary Outcome Measures :
  1. Clinical status after using antiseptic mouth rinse for 7 days [ Time Frame: 7 days ]
    Subject's clinical status at day 7 and the number of COVID-19 symptoms, symptoms onset and the severity of symptoms will be collected throughout Phase 2 of the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05239598


Contacts
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Contact: Michelle Shuster, MPH 2155736243 mbs74@upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michelle Shuster, MPH    215-573-6243    mbs74@upenn.edu   
Principal Investigator: Patricia Corby, DDS, MS         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Patricia Corby, DDS, MS University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT05239598    
Other Study ID Numbers: 849386
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases