Nasal Irrigation to Reduce COVID-19 Morbidity
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|ClinicalTrials.gov Identifier: NCT04559035|
Recruitment Status : Completed
First Posted : September 22, 2020
Last Update Posted : December 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Other: Nasal lavage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||239 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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:||Single (Outcomes Assessor)|
|Masking Description:||Hospitalization records were confirmed by study personnel blinded to participant status.|
|Official Title:||Nasal Irrigation to Reduce COVID-19 Morbidity|
|Actual Study Start Date :||September 24, 2020|
|Actual Primary Completion Date :||January 18, 2021|
|Actual Study Completion Date :||November 4, 2021|
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.
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.
- 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.
- 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.
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
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Matt Lyon, MD||Augusta University|