Official Title
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
Brief Summary

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

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.

Withdrawn
COVID-19

Drug: Saline oral/nasal rinse

5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.

Drug: 0.5% Povidone/Iodine oral/nasal rinse

5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.

Drug: 0.12% Chlorhexidine oral/nasal rinse

5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.

Eligibility Criteria

Inclusion Criteria:

1. Positive test for COVID-19

2. Age 18-79 years

3. Willing and able to perform oral gargles and nasal rinses four times daily

Exclusion Criteria

1. Requiring mechanical ventilation

2. Unable or unwilling to perform oral gargles and nasal rinses four times daily

3. History of chronic upper respiratory tract disease

4. Known iodine allergy

5. History of thyroid disease

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 79 Years
Countries
United States
Locations

NYU Langone Health
New York, New York, United States

Scott Rickert, MD, Principal Investigator
NYU Langone Health

NYU Langone Health
NCT Number
MeSH Terms
COVID-19
Chlorhexidine
Povidone-Iodine
Povidone