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Nasal Irrigation to Reduce COVID-19 Morbidity

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04559035
Recruitment Status : Enrolling by invitation
First Posted : September 22, 2020
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Matt Lyon, Augusta University

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 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 will be done with either Betadine or baking soda to determine if adding an antimicrobial or changing the pH of the mucous helps.

Condition or disease Intervention/treatment Phase
Covid19 Other: Nasal lavage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal Irrigation to Reduce COVID-19 Morbidity
Actual Study Start Date : September 12, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Betadine

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
Twice daily nasal lavage.

Baking Soda
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
Twice daily nasal lavage.




Primary Outcome Measures :
  1. Frequency [ Time Frame: 28 days ]

    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 :
  1. Reduction [ Time Frame: 28 days ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04559035


Locations
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United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: Matt Lyon, MD Augusta University
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Responsible Party: Matt Lyon, Principal Investigator, Augusta University
ClinicalTrials.gov Identifier: NCT04559035    
Other Study ID Numbers: 1603291
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No