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

NYU Langone Health

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19

Treatments: Drug: 0.5% Povidone/Iodine oral/nasal rinse; Drug: Saline oral/nasal rinse; Drug: 0.12% Chlorhexidine oral/nasal rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT04344236

s20-00444

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Control

No Intervention group

Saline oral/nasal rinse

Experimental group

Treatment:

Drug: Saline oral/nasal rinse

0.5% Povidone/Iodine oral/nasal rinse

Experimental group

Treatment:

Drug: 0.5% Povidone/Iodine oral/nasal rinse

0.12% Chlorhexidine oral/nasal rinse

Experimental group

Treatment:

Drug: 0.12% Chlorhexidine oral/nasal rinse