Povidone-Iodine Rinses in the Management of COVID-19

July 7, 2022 updated by: Amin Javer, St. Paul's Hospital, Canada

The Efficacy of Topical Povidone-Iodine Rinses in the Management of the Coronavirus Disease 2019 (COVID-19)

The aim of this study is to determine if Povidone iodine (PVP-I) rinses and throat gargles or a PVP-I gel forming nasal spray compared to a placebo (a treatment that has no physical effect to a person) is an effective treatment for patients diagnosed with COVID-19. These patients have been diagnosed with mild/moderate COVID-19 symptoms and sent home for self-isolation. Patients will be instructed to take either of the two treatments or placebo twice daily for two weeks and have follow up visits 2 and 4 weeks after. The participants will also complete study related procedures such as saliva sample collection, and two questionnaires throughout the study period. The investigators hypothesize that COVID 19 positive participants who use either of the Povidone - Iodine treatment will have a reduction in their viral load, develop a negative oral mucosa sample and improve their clinical symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed study is a prospective randomized double blinded placebo-controlled study of 6-weeks in duration. Patients who have tested positive and diagnosed with COVID-19 within the previous 72 h and who meet the inclusion and exclusion criteria, will be invited to participate in this study.

This study will be involving non-hospitalized patients who are recovering at home. One arm will use betadine sinonasal rinses and a betadine mouth gargle while another arm will act as a control receiving a placebo (a food coloring agent). A third arm will use a 0.6% PVP-I gel forming nasal spray twice daily. A baseline saliva sample will be collected to assure a positive COVID-19 test and to quantify viral load. Repeat saliva samples will be collected every 2 days for 2 weeks, then at 4 weeks and 6 weeks to quantify test status and quantify viral load reduction. WURSS-44 questionnaires will be completed daily for 2 weeks and then again at 4 weeks and 6 weeks. SNOT-22 questionnaires will be completed at baseline and then again at 2 weeks, 4 weeks, and 6 weeks. The investigators will also monitor for worsening of symptoms and the need for hospitalization for the entire 6 week duration of the study.

Upon enrolment in the study after obtaining positive results for COVID-19, demographic data and clinical data will be obtained by the investigators. Patients will be randomly assigned to one of the study arms delineated above by permuted block randomization

The clinical samples that detect COVID-19 are obtained by collecting a saliva sample prior to rinsing. This will avoid confounding by artificially lowering the viral particles sampled and will minimize any potentially inhibitory effects of the intervention compounds on lab detection. The sample will be put into a sterile collection container and stored in the fridge until it is transported to the laboratory for analysis.

Sample Size

Considering the quick turnover and the rapid doubling time in the number of positive cases and the unprecedented nature of this study's design and treatment, the investigators hope to recruit 20 patients in each study arm as a pilot study around this subject matter. To account for a drop-out rate of 25% the investigators plan to recruit 27 patients in each arm.

Analysis

Primary outcomes

  1. Time to a negative/undetectable RT-PCR SARS-CoV-2 saliva sample amongst patients rinsing and gargling with 0.23% PVP-I compared to a placebo group measured during the study treatment daily for 2 weeks and at the 4-week and 6-week mark.

    1.1. A Kaplan-Meier curve and log rank test will be used to compare the time to a negative saliva test from the start of the study between patients receiving PVP-I to those receiving the placebo. A hazard ratio of >1 will favor treatment with PVP-I, calculated with a 95% confidence interval by Cox proportional hazards model.

    1.2. The median time to negative swab in the PVP-I group versus the control will be statistically compared using the unpaired Mann-Whitney U test.

    1.3. The proportion of patients with a negative sample will be compared between the PVP-I group and control group at all times points using the Chi-squared test.

    1.4. A subsequent risk factor analysis will be conducted using the cox proportional hazards model, investigating the independent influence of various host and disease factors on the time to a negative sample during the study period. The following relevant factors included in the multivariable regression were identified a priori upon consultation with experienced clinicians at our center: gender, age, smoking status (yes/no), baseline viral load, known baseline lung comorbidity (yes/no) , duration of symptoms before treatment.

  2. SARS-CoV-2 viral load changes in the saliva amongst patients rinsing and gargling with 0.23% PVP-I compared to a placebo group measured during the study treatment daily for 2 weeks and at the 4-week and 6-week mark.

    2.1. Logarithmic viral load levels in the saliva samples will be graphed and compared between the PVP-I and placebo group at all time points using the unpaired Mann-Whitney U test. For complete statistical analysis, a value of 1 log base 10 copies/mL will be assigned to samples with undetectable viral levels.

  3. Time to a negative/undetectable SARS-CoV-2 saliva sample as well as SARS-CoV-2 viral load changes amongst patients rinsing and gargling with 0.23% PVP-I compared to the 0.6% PVP-I gel forming nasal spray for 2 weeks and at the 4-week and 6-week mark.

3.1. Similar analysis as per 1.1, 1.2, 1.3 and 2.1 above in primary outcomes.

Secondary outcomes

  1. Change in symptom scores between the PVP-I group and placebo group as assessed by the SNOT-22 scores collected at baseline and at the 2-week, 4-week and 6-week mark.

    1.1. SNOT-22 scores will be graphed and compared between baseline and each time point for each group separately using the ANOVA with repeated measures test and Bonferroni post hoc test.

    1.2. The change in SNOT-22 scores between baseline and each time point will be compared between groups using the unpaired Mann-Whitney U test.

  2. Change in symptom scores between the PVP-I group and placebo group as assessed by the WURSS-44 scores collected daily from baseline for 2 weeks and at the 4-week and 6-week mark.

    2.1. WURSS-44 scores will be graphed and compared between baseline, the 2 week, 4-week and 6-week marks for each group separately using the ANOVA with repeated measures test and Bonferroni post hoc test.

    2.2. WURSS-44 scores will be graphed and compared between baseline and at all time points using the unpaired Mann-Whitney U test.

  3. The need for hospitalization between the PVP-I group and placebo group. 3.1. The Kaplan-Meier technique will also be used to compare the need for hospitalization from the start of the study between both groups.
  4. The change in SNOT-22 scores, WURSS-44 scores and the need for hospitalization between patients rinsing and gargling with 0.23% PVP-I compared to the 0.6% PVP-I gel forming nasal spray.

4.1. Similar analysis as per 1.1, 1.2, 2.1, 2.2 and 3.1 above in secondary outcomes.

Descriptive statistics (mean, median, SD) will be used to describe demographic characteristics of the patients. Results will be considered statistically significant with p values < 0.05. All statistical analyzes will be performed using RStudio version 3.4.1 (RStudio, Boston, MA, USA).

Assessment of Safety

Safety Monitoring

Patients who experience signs and symptoms of iodine reaction will be noted and the code will be broken so that a discussion can occur between the research supervisor and the patient regarding the use of the topical iodine.

Patients can contact the office anytime if they notice any of the signs or symptoms of iodine reaction and will be seen by the research supervisor (or designate) within 24 hours.

Adverse Events (AE's)

All expected and unexpected adverse events will be recorded and graded by the research supervisor. Stable chronic conditions, which are present prior to the clinical trial entry and do not worsen, are not considered adverse events and will be accounted for in the patient's medical history.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 19 years or older
  • Patients diagnosed with laboratory-confirmed SARS-CoV-2 and the development of COVID-19 compatible symptoms within the last 72 hours before enrolment
  • Do not require hospitalization

Exclusion Criteria:

  • Sinonasal tumor
  • Hypersensitivity to iodine or betadine
  • History of thyroid disorder including thyroid cancer, hyperthyroidism and hypothyroidism
  • Use of medications for thyroid disorders including thyroxine and carbimazole
  • Current use of topical iodine or betadine for another reason
  • Participating in any study with therapies directed at COVID-19 that could influence our results
  • Are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PVP-I sinus rinses and throat gargles
Participants will dilute 7 mL of 10% PVP-I into 300 mL of saline for a final concentration of 0.23% available iodine. They will be instructed to rinse each nostril with 120ml (total 240mL) in a NeilMedTM sinus rinse bottle, and gargle with 60 mL of the solution.
Drug: Povidone-iodine
This will be performed twice daily for two weeks.
Other Names:
  • Betadine
Placebo Comparator: Placebo sinus rinses and throat gargles
Participants will dilute 7 mL of PVP-I placebo into 300 mL of saline. They will be instructed to rinse each nostril with 120ml (total 240mL) in a NeilMedTM sinus rinse bottle, and gargle with 60 mL of the solution.
Drug: Placebo
This will be performed twice daily for two weeks.
Experimental: PVP-I gel forming nasal spray
0.6% PVP-I gel forming nasal spray will come prepared and ready for participants to use. They will be instructed to use two sprays to each nostril each time they administer the spray.
Drug: Povidone-iodine
This will be performed twice daily for two weeks.
Other Names:
  • Betadine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in SARS-CoV-2 positivity in the saliva
Time Frame: A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks
A saliva sample will be analyzed to monitor the duration of positivity and when test becomes negative for SARS-CoV-2.
A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks
Change in the SAR-CoV-2 viral load in the saliva
Time Frame: A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks
Quantify the amount of SAR-CoV-2 viral load present in the saliva.
A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Wisconsin Upper Respiratory Symptom Survey (WURSS-44)
Time Frame: daily for 2 weeks, 4 weeks, and 6 weeks
This is a 44 question, quality of life survey designed to measure different aspects affected by the common cold.
daily for 2 weeks, 4 weeks, and 6 weeks
Change Sino nasal Outcome Test (SNOT-22)
Time Frame: baseline, 2 weeks, 4 weeks, 6 weeks
That includes 22 questions about symptoms and social/emotional consequences of your nasal disorder.
baseline, 2 weeks, 4 weeks, 6 weeks
Change in clinical condition
Time Frame: daily for 2 weeks, 4 weeks, and 6 weeks
We will record and worsening of clinical condition such as, need for hospitalization/oxygen support.
daily for 2 weeks, 4 weeks, and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Paul's Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Betadine COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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