Nasal Irrigation to Reduce COVID-19 Morbidity

NCT04559035 | Completed

• 1 other identifier: 1603291
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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+

Conditions

Covid19

Keywords

prevention; nasal lavage; povidone-iodine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction

  28 days

Study Arms (2)

Betadine

OTHER

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.

Other: Nasal lavage

Baking Soda

OTHER

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.

Other: Nasal lavage

Interventions

Nasal lavage OTHER

Twice daily nasal lavage.

Baking Soda; Betadine

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Related Publications (8)

• 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.

  PMID: 32520599 BACKGROUND

• 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.

  PMID: 32951446 BACKGROUND

• 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.

  PMID: 32511851 BACKGROUND

• 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.

  PMID: 32940656 BACKGROUND

• 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.

  PMID: 33864917 BACKGROUND

• 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.

  PMID: 32643111 BACKGROUND

• 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.

  PMID: 33538761 BACKGROUND

• 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.

  PMID: 33914069 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Nasal Lavage

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Matt Lyon, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Hospitalization records were confirmed by study personnel blinded to participant status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible Party

Model Details: 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

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 22, 2020
• Study Start: September 24, 2020
• Primary Completion: January 18, 2021
• Study Completion: November 4, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)