Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19

Study Overview
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Brief Summary
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For this study, 48 patients who have been diagnosed with COVID-19 will be randomly assigned to four study groups: control, saline, chlorhexidine gluconate, and povidone-iodine. Each patient will be asked to gargle with a solution of either saline, chlorhexidine gluconate, or povidone-iodine or nothing (control group) as well as spray the same solution in their nose four times daily. Patients will then be tested for COVID-19 once daily in the evening for 7 days and viral loads will be measured.

Detailed Description
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COVID-19 has emerged as a worldwide pandemic and there is a strong need for identification of any measures that can be used to treat this illness or reduce its transmission from person to person. Povidone-iodine has been shown to have virucidal properties against multiple viruses including against the virus that causes SARS which is very similar in makeup to the virus causing COVID-19. The investigators hypothesize that 4x daily use of oral gargles and nasal rinses using a povidone iodine solution will help to reduce the viral load in the nasopharynx and oropharynx in patients who are COVID-19+. If this hypothesis is shown to be true this could potentially have an impact on time to recovery of clinical symptoms as well as reduce shedding of the virus by infected patients. A time course of 7 days was chosen in order to recognize a trend in the viral load over time for patients receiving each of the interventions. Chlorhexidine gluconate and saline rinses were chosen as additional treatment arms as these are frequently used for oral and nasal hygiene and their role in affecting viral load is currently unknown.

Official Title
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A Phase II, Randomized, Open-label, Single-institution Study of the Effects of Povidone Iodine Oral Gargles and Nasal Rinses on Viral Load in Patients With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Saline oral/nasal rinse
* Drug: 0.5% Povidone/Iodine oral/nasal rinse
* Drug: 0.12% Chlorhexidine oral/nasal rinse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive test for COVID-19 Age 18-79 years Willing and able to perform oral gargles and nasal rinses four times daily Exclusion Criteria Requiring mechanical ventilation Unable or unwilling to perform oral gargles and nasal rinses four times daily History of chronic upper respiratory tract disease Known iodine allergy History of thyroid disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Saline oral/nasal rinse<br> | Drug: Saline oral/nasal rinse<br>* 5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.<br>|
| Experimental: 0.5% Povidone/Iodine oral/nasal rinse<br> | Drug: 0.5% Povidone/Iodine oral/nasal rinse<br>* 5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.<br>|
| Experimental: 0.12% Chlorhexidine oral/nasal rinse<br> | Drug: 0.12% Chlorhexidine oral/nasal rinse<br>* 5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load (and/or cycle time to PCR as a proxy for quantitative viral load) in the nasopharynx and oropharynx | nasopharyngeal swab for viral PCR will be taken at the end of each day for 7 days | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen requirement of the patient | Recorded daily | 7 days | 
| Oxygen saturation of the patient | Recorded daily | 7 days |