Nasal Irrigation to Reduce COVID-19 Morbidity

Covid19 Clinical Trial

Official title:

Nasal Irrigation to Reduce COVID-19 Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559035
• Other study ID #: 1603291
• Status: Completed
• Phase: N/A
• Start date: September 24, 2020
• Est. completion date: November 4, 2021

Study information

• Verified date: December 2021
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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+

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: November 4, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Nasal lavage
Twice daily nasal lavage.

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. Review. — View Citation

Guenezan J, Garcia M, Strasters D, Jousselin C, Lévêque 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. — View 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. — View 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. — View 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. Erratum in: JAMA Otolaryngol Head Neck Surg. 2021 Jul 1;147(7):681. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days
Secondary	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.	28 days