<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04449965</url>
  </required_header>
  <id_info>
    <org_study_id>Betadine COVID-19</org_study_id>
    <nct_id>NCT04449965</nct_id>
  </id_info>
  <brief_title>Povidone-Iodine Rinses in the Management of COVID-19</brief_title>
  <official_title>The Efficacy of Topical Povidone-Iodine Rinses in the Management of the Coronavirus Disease 2019 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Paul's Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Paul's Hospital, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine if Povidone iodine (PVP-I) rinses and throat gargles or&#xD;
      a PVP-I gel forming nasal spray compared to a placebo (a treatment that has no physical&#xD;
      effect to a person) is an effective treatment for patients diagnosed with COVID-19. These&#xD;
      patients have been diagnosed with mild/moderate COVID-19 symptoms and sent home for&#xD;
      self-isolation. Patients will be instructed to take either of the two treatments or placebo&#xD;
      twice daily for two weeks and have follow up visits 2 and 4 weeks after. The participants&#xD;
      will also complete study related procedures such as saliva sample collection, and two&#xD;
      questionnaires throughout the study period. The investigators hypothesize that COVID 19&#xD;
      positive participants who use either of the Povidone - Iodine treatment will have a reduction&#xD;
      in their viral load, develop a negative oral mucosa sample and improve their clinical&#xD;
      symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a prospective randomized double blinded placebo-controlled study of&#xD;
      6-weeks in duration. Patients who have tested positive and diagnosed with COVID-19 within the&#xD;
      previous 72 h and who meet the inclusion and exclusion criteria, will be invited to&#xD;
      participate in this study.&#xD;
&#xD;
      This study will be involving non-hospitalized patients who are recovering at home. One arm&#xD;
      will use betadine sinonasal rinses and a betadine mouth gargle while another arm will act as&#xD;
      a control receiving a placebo (a food coloring agent). A third arm will use a 0.6% PVP-I gel&#xD;
      forming nasal spray twice daily. A baseline saliva sample will be collected to assure a&#xD;
      positive COVID-19 test and to quantify viral load. Repeat saliva samples will be collected&#xD;
      every 2 days for 2 weeks, then at 4 weeks and 6 weeks to quantify test status and quantify&#xD;
      viral load reduction. WURSS-44 questionnaires will be completed daily for 2 weeks and then&#xD;
      again at 4 weeks and 6 weeks. SNOT-22 questionnaires will be completed at baseline and then&#xD;
      again at 2 weeks, 4 weeks, and 6 weeks. The investigators will also monitor for worsening of&#xD;
      symptoms and the need for hospitalization for the entire 6 week duration of the study.&#xD;
&#xD;
      Upon enrolment in the study after obtaining positive results for COVID-19, demographic data&#xD;
      and clinical data will be obtained by the investigators. Patients will be randomly assigned&#xD;
      to one of the study arms delineated above by permuted block randomization&#xD;
&#xD;
      The clinical samples that detect COVID-19 are obtained by collecting a saliva sample prior to&#xD;
      rinsing. This will avoid confounding by artificially lowering the viral particles sampled and&#xD;
      will minimize any potentially inhibitory effects of the intervention compounds on lab&#xD;
      detection. The sample will be put into a sterile collection container and stored in the&#xD;
      fridge until it is transported to the laboratory for analysis.&#xD;
&#xD;
      Sample Size&#xD;
&#xD;
      Considering the quick turnover and the rapid doubling time in the number of positive cases&#xD;
      and the unprecedented nature of this study's design and treatment, the investigators hope to&#xD;
      recruit 20 patients in each study arm as a pilot study around this subject matter. To account&#xD;
      for a drop-out rate of 25% the investigators plan to recruit 27 patients in each arm.&#xD;
&#xD;
      Analysis&#xD;
&#xD;
      Primary outcomes&#xD;
&#xD;
        1. Time to a negative/undetectable RT-PCR SARS-CoV-2 saliva sample amongst patients rinsing&#xD;
           and gargling with 0.23% PVP-I compared to a placebo group measured during the study&#xD;
           treatment daily for 2 weeks and at the 4-week and 6-week mark.&#xD;
&#xD;
           1.1. A Kaplan-Meier curve and log rank test will be used to compare the time to a&#xD;
           negative saliva test from the start of the study between patients receiving PVP-I to&#xD;
           those receiving the placebo. A hazard ratio of &gt;1 will favor treatment with PVP-I,&#xD;
           calculated with a 95% confidence interval by Cox proportional hazards model.&#xD;
&#xD;
           1.2. The median time to negative swab in the PVP-I group versus the control will be&#xD;
           statistically compared using the unpaired Mann-Whitney U test.&#xD;
&#xD;
           1.3. The proportion of patients with a negative sample will be compared between the&#xD;
           PVP-I group and control group at all times points using the Chi-squared test.&#xD;
&#xD;
           1.4. A subsequent risk factor analysis will be conducted using the cox proportional&#xD;
           hazards model, investigating the independent influence of various host and disease&#xD;
           factors on the time to a negative sample during the study period. The following relevant&#xD;
           factors included in the multivariable regression were identified a priori upon&#xD;
           consultation with experienced clinicians at our center: gender, age, smoking status&#xD;
           (yes/no), baseline viral load, known baseline lung comorbidity (yes/no) , duration of&#xD;
           symptoms before treatment.&#xD;
&#xD;
        2. SARS-CoV-2 viral load changes in the saliva amongst patients rinsing and gargling with&#xD;
           0.23% PVP-I compared to a placebo group measured during the study treatment daily for 2&#xD;
           weeks and at the 4-week and 6-week mark.&#xD;
&#xD;
           2.1. Logarithmic viral load levels in the saliva samples will be graphed and compared&#xD;
           between the PVP-I and placebo group at all time points using the unpaired Mann-Whitney U&#xD;
           test. For complete statistical analysis, a value of 1 log base 10 copies/mL will be&#xD;
           assigned to samples with undetectable viral levels.&#xD;
&#xD;
        3. Time to a negative/undetectable SARS-CoV-2 saliva sample as well as SARS-CoV-2 viral&#xD;
           load changes amongst patients rinsing and gargling with 0.23% PVP-I compared to the 0.6%&#xD;
           PVP-I gel forming nasal spray for 2 weeks and at the 4-week and 6-week mark.&#xD;
&#xD;
      3.1. Similar analysis as per 1.1, 1.2, 1.3 and 2.1 above in primary outcomes.&#xD;
&#xD;
      Secondary outcomes&#xD;
&#xD;
        1. Change in symptom scores between the PVP-I group and placebo group as assessed by the&#xD;
           SNOT-22 scores collected at baseline and at the 2-week, 4-week and 6-week mark.&#xD;
&#xD;
           1.1. SNOT-22 scores will be graphed and compared between baseline and each time point&#xD;
           for each group separately using the ANOVA with repeated measures test and Bonferroni&#xD;
           post hoc test.&#xD;
&#xD;
           1.2. The change in SNOT-22 scores between baseline and each time point will be compared&#xD;
           between groups using the unpaired Mann-Whitney U test.&#xD;
&#xD;
        2. Change in symptom scores between the PVP-I group and placebo group as assessed by the&#xD;
           WURSS-44 scores collected daily from baseline for 2 weeks and at the 4-week and 6-week&#xD;
           mark.&#xD;
&#xD;
           2.1. WURSS-44 scores will be graphed and compared between baseline, the 2 week, 4-week&#xD;
           and 6-week marks for each group separately using the ANOVA with repeated measures test&#xD;
           and Bonferroni post hoc test.&#xD;
&#xD;
           2.2. WURSS-44 scores will be graphed and compared between baseline and at all time&#xD;
           points using the unpaired Mann-Whitney U test.&#xD;
&#xD;
        3. The need for hospitalization between the PVP-I group and placebo group. 3.1. The&#xD;
           Kaplan-Meier technique will also be used to compare the need for hospitalization from&#xD;
           the start of the study between both groups.&#xD;
&#xD;
        4. The change in SNOT-22 scores, WURSS-44 scores and the need for hospitalization between&#xD;
           patients rinsing and gargling with 0.23% PVP-I compared to the 0.6% PVP-I gel forming&#xD;
           nasal spray.&#xD;
&#xD;
      4.1. Similar analysis as per 1.1, 1.2, 2.1, 2.2 and 3.1 above in secondary outcomes.&#xD;
&#xD;
      Descriptive statistics (mean, median, SD) will be used to describe demographic&#xD;
      characteristics of the patients. Results will be considered statistically significant with p&#xD;
      values &lt; 0.05. All statistical analyzes will be performed using RStudio version 3.4.1&#xD;
      (RStudio, Boston, MA, USA).&#xD;
&#xD;
      Assessment of Safety&#xD;
&#xD;
      Safety Monitoring&#xD;
&#xD;
      Patients who experience signs and symptoms of iodine reaction will be noted and the code will&#xD;
      be broken so that a discussion can occur between the research supervisor and the patient&#xD;
      regarding the use of the topical iodine.&#xD;
&#xD;
      Patients can contact the office anytime if they notice any of the signs or symptoms of iodine&#xD;
      reaction and will be seen by the research supervisor (or designate) within 24 hours.&#xD;
&#xD;
      Adverse Events (AE's)&#xD;
&#xD;
      All expected and unexpected adverse events will be recorded and graded by the research&#xD;
      supervisor. Stable chronic conditions, which are present prior to the clinical trial entry&#xD;
      and do not worsen, are not considered adverse events and will be accounted for in the&#xD;
      patient's medical history.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The site struggled with patient recruitment as we were not able to reach patients with COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">January 19, 2021</start_date>
  <completion_date type="Actual">August 16, 2021</completion_date>
  <primary_completion_date type="Actual">August 16, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The investigator will be blinded to whether or not the patients are receiving either active treatments or placebo, and assignments will be concealed throughout the study. The patients will know if they are in the nasal gel spray or rinse group but will be blinded to whether or not they are receiving the active treatment or placebo if they are randomized into the rinse group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in SARS-CoV-2 positivity in the saliva</measure>
    <time_frame>A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks</time_frame>
    <description>A saliva sample will be analyzed to monitor the duration of positivity and when test becomes negative for SARS-CoV-2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the SAR-CoV-2 viral load in the saliva</measure>
    <time_frame>A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks</time_frame>
    <description>Quantify the amount of SAR-CoV-2 viral load present in the saliva.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Wisconsin Upper Respiratory Symptom Survey (WURSS-44)</measure>
    <time_frame>daily for 2 weeks, 4 weeks, and 6 weeks</time_frame>
    <description>This is a 44 question, quality of life survey designed to measure different aspects affected by the common cold.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Sino nasal Outcome Test (SNOT-22)</measure>
    <time_frame>baseline, 2 weeks, 4 weeks, 6 weeks</time_frame>
    <description>That includes 22 questions about symptoms and social/emotional consequences of your nasal disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinical condition</measure>
    <time_frame>daily for 2 weeks, 4 weeks, and 6 weeks</time_frame>
    <description>We will record and worsening of clinical condition such as, need for hospitalization/oxygen support.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>PVP-I sinus rinses and throat gargles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo sinus rinses and throat gargles</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PVP-I gel forming nasal spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone-iodine</intervention_name>
    <description>This will be performed twice daily for two weeks.</description>
    <arm_group_label>PVP-I gel forming nasal spray</arm_group_label>
    <arm_group_label>PVP-I sinus rinses and throat gargles</arm_group_label>
    <other_name>Betadine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>This will be performed twice daily for two weeks.</description>
    <arm_group_label>Placebo sinus rinses and throat gargles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19 years or older&#xD;
&#xD;
          -  Patients diagnosed with laboratory-confirmed SARS-CoV-2 and the development of&#xD;
             COVID-19 compatible symptoms within the last 72 hours before enrolment&#xD;
&#xD;
          -  Do not require hospitalization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sinonasal tumor&#xD;
&#xD;
          -  Hypersensitivity to iodine or betadine&#xD;
&#xD;
          -  History of thyroid disorder including thyroid cancer, hyperthyroidism and&#xD;
             hypothyroidism&#xD;
&#xD;
          -  Use of medications for thyroid disorders including thyroxine and carbimazole&#xD;
&#xD;
          -  Current use of topical iodine or betadine for another reason&#xD;
&#xD;
          -  Participating in any study with therapies directed at COVID-19 that could influence&#xD;
             our results&#xD;
&#xD;
          -  Are pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Paul's Hospital, Canada</investigator_affiliation>
    <investigator_full_name>Amin Javer</investigator_full_name>
    <investigator_title>Assistant Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Povidone - Iodine</keyword>
  <keyword>Covid19</keyword>
  <keyword>Self-Isolation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04449965
org study id: Betadine COVID-19
nct id: NCT04449965
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The investigator will be blinded to whether or not the patients are receiving either active treatments or placebo, and assignments will be concealed throughout the study. The patients will know if they are in the nasal gel spray or rinse group but will be blinded to whether or not they are receiving the active treatment or placebo if they are randomized into the rinse group.
measure: 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
description: A saliva sample will be analyzed to monitor the duration of positivity and when test becomes negative for SARS-CoV-2.
measure: 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
description: Quantify the amount of SAR-CoV-2 viral load present in the saliva.
measure: Change in Wisconsin Upper Respiratory Symptom Survey (WURSS-44)
time frame: daily for 2 weeks, 4 weeks, and 6 weeks
description: This is a 44 question, quality of life survey designed to measure different aspects affected by the common cold.
measure: Change Sino nasal Outcome Test (SNOT-22)
time frame: baseline, 2 weeks, 4 weeks, 6 weeks
description: That includes 22 questions about symptoms and social/emotional consequences of your nasal disorder.
measure: Change in clinical condition
time frame: daily for 2 weeks, 4 weeks, and 6 weeks
description: We will record and worsening of clinical condition such as, need for hospitalization/oxygen support.
arm group label: PVP-I sinus rinses and throat gargles
arm group type: Experimental
description: 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.
arm group label: Placebo sinus rinses and throat gargles
arm group type: Placebo Comparator
description: 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.
arm group label: PVP-I gel forming nasal spray
arm group type: Experimental
description: 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.
intervention type: Drug
intervention name: Povidone-iodine
description: This will be performed twice daily for two weeks.
arm group label: PVP-I gel forming nasal spray
arm group label: PVP-I sinus rinses and throat gargles
other name: Betadine
intervention type: Drug
intervention name: Placebo
description: This will be performed twice daily for two weeks.
arm group label: Placebo sinus rinses and throat gargles
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Paul's Hospital, Canada
investigator full name: Amin Javer
investigator title: Assistant Clinical Professor
mesh term: COVID-19
mesh term: Povidone-Iodine
mesh term: Povidone