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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344236
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Saline oral/nasal rinse Drug: 0.5% Povidone/Iodine oral/nasal rinse Drug: 0.12% Chlorhexidine oral/nasal rinse Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled open label trial, parallel design
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 9, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Experimental: Saline oral/nasal rinse 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.

Experimental: 0.5% Povidone/Iodine oral/nasal rinse 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.

Experimental: 0.12% Chlorhexidine oral/nasal rinse 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.




Primary Outcome Measures :
  1. Viral load (and/or cycle time to PCR as a proxy for quantitative viral load) in the nasopharynx and oropharynx [ Time Frame: 7 days ]
    nasopharyngeal swab for viral PCR will be taken at the end of each day for 7 days


Secondary Outcome Measures :
  1. Oxygen requirement of the patient [ Time Frame: 7 days ]
    Recorded daily

  2. Oxygen saturation of the patient [ Time Frame: 7 days ]
    Recorded daily



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344236


Contacts
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Contact: Scott Rickert, MD 646-501-7890 scott.rickert@nyulangone.org
Contact: Lindsey Moses, MD Lindsey.moses@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Scott Rickert       scott.rickert@nyulangone.org   
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Scott Rickert, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04344236    
Other Study ID Numbers: s20-00444
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: Requests should be directed to scott.rickert@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Chlorhexidine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Plasma Substitutes
Blood Substitutes