NCT04344236

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-09
• Primary completion: 2020-05-01
• Completion: 2020-05-09
• First posted: 2020-04-14
• Last updated: 2021-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study