Povidone-Iodine Rinses in the Management of COVID-19

NCT04449965 | Terminated Early Phase 1

• 1 other identifier: Betadine COVID-19
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Povidone - Iodine; Covid19; Self-Isolation

Outcome Measures

Primary Outcomes (2)

• Change in SARS-CoV-2 positivity in the saliva

  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

  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 Outcomes (3)

• Change in Wisconsin Upper Respiratory Symptom Survey (WURSS-44)

  daily for 2 weeks, 4 weeks, and 6 weeks

• Change Sino nasal Outcome Test (SNOT-22)

  baseline, 2 weeks, 4 weeks, 6 weeks

• Change in clinical condition

  daily for 2 weeks, 4 weeks, and 6 weeks

Study Arms (3)

PVP-I sinus rinses and throat gargles

EXPERIMENTAL

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

Placebo sinus rinses and throat gargles

PLACEBO COMPARATOR

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

PVP-I gel forming nasal spray

EXPERIMENTAL

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

Interventions

Povidone-iodine DRUG

This will be performed twice daily for two weeks.

Also known as: Betadine

PVP-I gel forming nasal spray; PVP-I sinus rinses and throat gargles

Placebo DRUG

This will be performed twice daily for two weeks.

Placebo sinus rinses and throat gargles

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

MeSH Terms

Conditions

COVID-19

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: January 19, 2021
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

CA (1)