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

NCT ID: NCT04344236

Last Updated: 2021-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-09

Study Completion Date

2020-05-09

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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled open label trial, parallel design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Saline oral/nasal rinse

Group Type EXPERIMENTAL

Saline oral/nasal rinse

Intervention Type DRUG

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

0.5% Povidone/Iodine oral/nasal rinse

Group Type EXPERIMENTAL

0.5% Povidone/Iodine oral/nasal rinse

Intervention Type DRUG

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

0.12% Chlorhexidine oral/nasal rinse

Group Type EXPERIMENTAL

0.12% Chlorhexidine oral/nasal rinse

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Rickert, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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s20-00444

Identifier Type: -

Identifier Source: org_study_id

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