Nasal Irrigation to Reduce COVID-19 Morbidity

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nasal lavage

About this trial

This is an interventional treatment trial for Covid19 focused on measuring prevention, nasal lavage, povidone-iodine

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Capable of understanding and providing informed consent using remote consent
Willingness and physical capacity to initiate nasal irrigation and to adhere to the protocol
Willing to give additional contact phone number of another person who will know the health status of the participant and agree to be contacted if needed for follow-up
55 years of age or older
Has access to and the willingness and ability to adhere to the technological requirement of the study i.e. able to use a smartphone for voice and text and email and access to the internet at home
English speaking
Positive rapid COVID-19 test performed the day of or the day before enrollment

Exclusion Criteria:

Currently doing daily nasal irrigation
Current supplemental oxygen therapy
Unwillingness to try nasal irrigation or use nasal irrigation twice a day
Nasal surgery within the past year or chronic sinusitis
Prior COVID-19 infection or positive test >1 day before present
Symptoms longer than 7 days prior to testing as reported to researchers
Allergy to iodine or shellfish
Participation in another prospective COVID related research project (clinical trial).
Employed and working as a healthcare worker.

Sites / Locations

Augusta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Betadine

Baking Soda

Arm Description

Intervention - twice-a-day nasal lavage Twice-a-day virucidal group: Participants randomized to betadine will receive 2 gallon jugs of distilled water, two NeilMed Sinus Irrigation bottles and 28 salination packets (with some extras), OR one Navage unit with 28 SaltPods (and some extras), and a cardboard receptacle labeled "used saline containers" to keep track of adherence. Those randomized to receive betadine will also receive one bottle of povidone-iodine, a one-sheet instruction with photographs demonstrating how to add ½ tsp betadine in addition to the salination packet to the sinus irrigation bottle or Navage unit reservoir prior to SaltPod, along with a ½ tsp measuring spoon.

Twice-a-day alkalinized group: Participants randomized to alkalinization will receive 2 gallon jugs of distilled water, two Neilmed bottles with 28 saline packets, OR one Navage unit with 28 SaltPods, and a cardboard receptacle labeled "used saline containers" to keep track of adherence. Those randomized to alkalinization will also receive a box of baking soda, ½ tsp measuring spoon and instructions on how to add the baking soda.

Outcomes

Primary Outcome Measures

Frequency

Rate of hospitalization by number of episodes of nasal irrigation out of 28 possible. To assess reduction in admission, in patients with differing nasal irrigation frequency over 14 days with an additional 14 day follow-up period.

Secondary Outcome Measures

Reduction

Reduction of severity of COVID outcomes by number of episodes of nasal irrigation out of 28 possible. Assess reduction in hospital visits, symptoms, supplemental oxygen use, ICU admission, and death in patients with differing nasal irrigation frequency. Reduction of severity of COVID outcomes by nasal irrigation with alkalination or virucidal additives. To assess reduction in admission, hospital visits, symptoms, supplemental oxygen use, ICU admission, and death in patients using alkalnization or virucidal additives to nasal irrigation over 14 days with an additional 14 day follow-up period, controlling for irrigation frequency.

Full Information

NCT ID

NCT04559035

First Posted

September 21, 2020

Last Updated

December 15, 2021

Sponsor

Augusta University

1. Study Identification

Unique Protocol Identification Number

NCT04559035

Brief Title

Nasal Irrigation to Reduce COVID-19 Morbidity

Official Title

Nasal Irrigation to Reduce COVID-19 Morbidity

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

September 24, 2020 (Actual)

Primary Completion Date

January 18, 2021 (Actual)

Study Completion Date

November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to evaluate if using nasal irrigation, also known as nasal lavage, for 14 days after a positive test in high risk patients can reduce the severity of symptoms associated with COVID-19. Nasal lavage consists of running salt water in one nostril and out the other to get rid of germs. Nasal irrigation was done with either Betadine or baking soda to determine if adding an antimicrobial or changing the pH of the mucous helped. Hospitalization and death were compared for combined nasal irrigation groups to the CDC dataset of patients aged 50+

Detailed Description

The purpose of this study is to evaluate if using nasal irrigation, also known as nasal lavage, can reduce the severity of symptoms associated with COVID-19. Nasal lavage consists of running salt water in one nostril and out the other to get rid of germs. Saline nasal irrigation with Betadine or baking soda will be evaluated. Participants will be asked to do several things during this study: watch a one minute video on YouTube, use a nasal irrigation device twice a day for 14 days, complete a one-time detailed survey and keep a research diary about their usage and symptoms using an on-line application called Qualtrics, agree to be texted reminders, be called on the phone if they fail to complete the daily diary two days in a row, agree to be called four times, and provide contact information for a secondary person who can be contacted if the primary participant is unavailable. Participation in this study does not involve any significant risks. However, some people may find using nasal irrigation causes them some discomfort. While there are no known benefits to participating in the study participants may see a reduction in their symptoms more quickly than if they didn't participate in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

prevention, nasal lavage, povidone-iodine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized clinical trial of two nasal irrigation protocols in outpatients PCR positive for SARS-CoV-2, nested in a prospective case:cohort using laboratory-confirmed cases in the CDC COVID-19 Case Surveillance dataset

Masking

Outcomes Assessor

Masking Description

Hospitalization records were confirmed by study personnel blinded to participant status.

Allocation

Randomized

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Betadine

Arm Type

Other

Arm Description

Intervention - twice-a-day nasal lavage Twice-a-day virucidal group: Participants randomized to betadine will receive 2 gallon jugs of distilled water, two NeilMed Sinus Irrigation bottles and 28 salination packets (with some extras), OR one Navage unit with 28 SaltPods (and some extras), and a cardboard receptacle labeled "used saline containers" to keep track of adherence. Those randomized to receive betadine will also receive one bottle of povidone-iodine, a one-sheet instruction with photographs demonstrating how to add ½ tsp betadine in addition to the salination packet to the sinus irrigation bottle or Navage unit reservoir prior to SaltPod, along with a ½ tsp measuring spoon.

Arm Title

Baking Soda

Arm Type

Other

Arm Description

Twice-a-day alkalinized group: Participants randomized to alkalinization will receive 2 gallon jugs of distilled water, two Neilmed bottles with 28 saline packets, OR one Navage unit with 28 SaltPods, and a cardboard receptacle labeled "used saline containers" to keep track of adherence. Those randomized to alkalinization will also receive a box of baking soda, ½ tsp measuring spoon and instructions on how to add the baking soda.

Intervention Type

Other

Intervention Name(s)

Nasal lavage

Intervention Description

Twice daily nasal lavage.

Primary Outcome Measure Information:

Title

Frequency

Description

Rate of hospitalization by number of episodes of nasal irrigation out of 28 possible. To assess reduction in admission, in patients with differing nasal irrigation frequency over 14 days with an additional 14 day follow-up period.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Reduction

Description

Reduction of severity of COVID outcomes by number of episodes of nasal irrigation out of 28 possible. Assess reduction in hospital visits, symptoms, supplemental oxygen use, ICU admission, and death in patients with differing nasal irrigation frequency. Reduction of severity of COVID outcomes by nasal irrigation with alkalination or virucidal additives. To assess reduction in admission, hospital visits, symptoms, supplemental oxygen use, ICU admission, and death in patients using alkalnization or virucidal additives to nasal irrigation over 14 days with an additional 14 day follow-up period, controlling for irrigation frequency.

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Capable of understanding and providing informed consent using remote consent Willingness and physical capacity to initiate nasal irrigation and to adhere to the protocol Willing to give additional contact phone number of another person who will know the health status of the participant and agree to be contacted if needed for follow-up 55 years of age or older Has access to and the willingness and ability to adhere to the technological requirement of the study i.e. able to use a smartphone for voice and text and email and access to the internet at home English speaking Positive rapid COVID-19 test performed the day of or the day before enrollment Exclusion Criteria: Currently doing daily nasal irrigation Current supplemental oxygen therapy Unwillingness to try nasal irrigation or use nasal irrigation twice a day Nasal surgery within the past year or chronic sinusitis Prior COVID-19 infection or positive test >1 day before present Symptoms longer than 7 days prior to testing as reported to researchers Allergy to iodine or shellfish Participation in another prospective COVID related research project (clinical trial). Employed and working as a healthcare worker.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matt Lyon, MD

Organizational Affiliation

Augusta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Augusta University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

32520599

Citation

Frank S, Capriotti J, Brown SM, Tessema B. Povidone-Iodine Use in Sinonasal and Oral Cavities: A Review of Safety in the COVID-19 Era. Ear Nose Throat J. 2020 Nov;99(9):586-593. doi: 10.1177/0145561320932318. Epub 2020 Jun 10.

Results Reference

background

PubMed Identifier

32951446

Citation

Pelletier JS, Tessema B, Frank S, Westover JB, Brown SM, Capriotti JA. Efficacy of Povidone-Iodine Nasal and Oral Antiseptic Preparations Against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2). Ear Nose Throat J. 2021 Apr;100(2_suppl):192S-196S. doi: 10.1177/0145561320957237. Epub 2020 Sep 21. Erratum In: Ear Nose Throat J. 2020 Dec 8;:145561320977784.

Results Reference

background

PubMed Identifier

32511851

Citation

Bidra AS, Pelletier JS, Westover JB, Frank S, Brown SM, Tessema B. Rapid In-Vitro Inactivation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Using Povidone-Iodine Oral Antiseptic Rinse. J Prosthodont. 2020 Jul;29(6):529-533. doi: 10.1111/jopr.13209. Epub 2020 Jun 16.

Results Reference

background

PubMed Identifier

32940656

Citation

Frank S, Brown SM, Capriotti JA, Westover JB, Pelletier JS, Tessema B. In Vitro Efficacy of a Povidone-Iodine Nasal Antiseptic for Rapid Inactivation of SARS-CoV-2. JAMA Otolaryngol Head Neck Surg. 2020 Nov 1;146(11):1054-1058. doi: 10.1001/jamaoto.2020.3053.

Results Reference

background

PubMed Identifier

33864917

Citation

Seet RCS, Quek AML, Ooi DSQ, Sengupta S, Lakshminarasappa SR, Koo CY, So JBY, Goh BC, Loh KS, Fisher D, Teoh HL, Sun J, Cook AR, Tambyah PA, Hartman M. Positive impact of oral hydroxychloroquine and povidone-iodine throat spray for COVID-19 prophylaxis: An open-label randomized trial. Int J Infect Dis. 2021 May;106:314-322. doi: 10.1016/j.ijid.2021.04.035. Epub 2021 Apr 20.

Results Reference

background

PubMed Identifier

32643111

Citation

Anderson DE, Sivalingam V, Kang AEZ, Ananthanarayanan A, Arumugam H, Jenkins TM, Hadjiat Y, Eggers M. Povidone-Iodine Demonstrates Rapid In Vitro Virucidal Activity Against SARS-CoV-2, The Virus Causing COVID-19 Disease. Infect Dis Ther. 2020 Sep;9(3):669-675. doi: 10.1007/s40121-020-00316-3. Epub 2020 Jul 8.

Results Reference

background

PubMed Identifier

33538761

Citation

Guenezan J, Garcia M, Strasters D, Jousselin C, Leveque N, Frasca D, Mimoz O. Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Apr 1;147(4):400-401. doi: 10.1001/jamaoto.2020.5490.

Results Reference

background

PubMed Identifier

33914069

Citation

Singh A, Yadav M, Sikka K. Regarding Use of Povidone Iodine to Reduce Nasopharyngeal Viral Load in Patients With COVID-19. JAMA Otolaryngol Head Neck Surg. 2021 Jul 1;147(7):680-681. doi: 10.1001/jamaoto.2021.0683. No abstract available. Erratum In: JAMA Otolaryngol Head Neck Surg. 2021 Jul 1;147(7):681.

Results Reference

background

Covid19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial