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Povidone-Iodine Rinses in the Management of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449965
Recruitment Status : Not yet recruiting
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Povidone-iodine Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: The Efficacy of Topical Povidone-Iodine Rinses in the Management of the Coronavirus Disease 2019 (COVID-19)
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: Betadine




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04449965


Contacts
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Contact: Laura Samson 604-806-9926 lsamson2@providencehealth.bc.ca

Sponsors and Collaborators
St. Paul's Hospital, Canada
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Responsible Party: Amin Javer, Assistant Clinical Professor, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT04449965    
Other Study ID Numbers: Betadine COVID-19
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020

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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
Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
Povidone - Iodine
Covid19
Self-Isolation
Additional relevant MeSH terms:
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Povidone-Iodine
Povidone
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents