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

Phase 2

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: Saline oral/nasal rinse; Drug: 0.5% Povidone/Iodine oral/nasal rinse; Drug: 0.12% Chlorhexidine oral/nasal rinse

• Registration Number: NCT04344236
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-08
• Study Start: 2020-04-09
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-14
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline oral/nasal rinse	Saline oral/nasal rinse	-
0.5% Povidone/Iodine oral/nasal rinse	0.5% Povidone/Iodine oral/nasal rinse	-
0.12% Chlorhexidine oral/nasal rinse	0.12% Chlorhexidine oral/nasal rinse	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Oxygen requirement of the patient	7 days	Recorded daily
Oxygen saturation of the patient	7 days	Recorded daily

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States