Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19

Study Overview
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Brief Summary
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The SARS-CoV-2 coronavirus pandemic is responsible for more than 180,000 deaths worldwide and 20,000 deaths in France. To date, no treatment or vaccine has been successful. Povidone-iodine is an antiseptic suitable for use on the skin and mucosa with potent virucidal activity, particularly against coronaviruses. It is marketed for oro-nasopharyngeal decolonization. 24 patients with positive nasopharyngeal SARS-CoV-2 carriage will be randomized (1:1) in an experimental group (benefiting from povidone iodine decolonization) or a control group. Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days. Patients will be followed for 7 days to evaluate the efficacy and safety of povidone iodine decolonization.

Official Title
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Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With SARS-CoV-2

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Povidone-Iodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (age over 18 yrs) of both sexes With positive SARS-CoV-2 carriage by RT-PCR Having given their written consent after having been informed Exclusion Criteria Patient with low viral load (threshold cycle [Ct] > 25 per RT-PCR), Patient unable to perform oro-nasopharyngeal decolonization Known hypersensitivity to one of the constituents, particularly to povidone-iodine, History of dysthyroidism, Known coagulopathy, Participation in another clinical trial aimed at reducing viral load in patients with SARS-CoV-2, Pregnant or breastfeeding women, or women of childbearing age without effective contraception Patients not covered by a social security scheme Patients with enhanced protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled open label trial, parallel design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decolonization<br>1% Povidone iodine mouthwash (95 mL), gargle, and nasal spray (2,5 mL by nostril), and 10% nasal gel (one drop). All four time a day for five days. | Drug: Povidone-Iodine<br>* Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days.<br>|
| No Intervention: Control<br>Absence of local decolonization | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7 |  | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage |  | Day0, Day1, Day3, Day5 and Day7 | 
| Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures |  | Day0, Day1, Day3, Day5 and Day7 | 
| Thyroid tests at Day0 and Day7 |  | Day0 and Day7 | 
| Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort) |  | Day7 | 
| Daily presence of clinical signs in favour of COVID-19, including respiratory distress using NYHA scale, chest pain, anosmia, agueusia, tiredness, cough, stiffness, nasal congestion, dysphagia and diarrhea |  | Day0, Day1, Day3, Day5 and Day7 | 
| Need for ward or intensive care hospitalization |  | Day0, Day1, Day3, Day5 and Day7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Povidone Iodine decolonization