Abstract
Objective To determine whether nasal irrigation initiated within 24 hours of a positive PCR test result reduces hospitalizations for COVID-19.
Design, Setting and Participants Prospective case:cohort trial comparing clinical outcomes in patients aged 55 years or older who were PCR positive at a community testing site in Augusta, Georgia. Patients randomized to initiate one of two nasal irrigation regimens were compared to outcomes in the CDC national database from September 23 to December 21, 2020 with follow up until January 18.
nterventions Participants were assigned on alternate days to one of two pressure-based nasal irrigation systems (NAVAGE, Rhinosystems Inc.) or Neilmed Sinus Rinse (Neilmed Inc.), and randomized to include 2.5ml povidone-iodine 10% (antimicrobial) or 0.5 teaspoon sodium bicarbonate (alkalinization) to the standard saline rinse twice daily for 14 days with 14 day follow-up.
Main Outcomes and Measures The primary outcome was hospitalization for COVID-19 symptoms within 28 days of enrollment by daily self-report confirmed with phone follow up and hospital records compared to hospitalization rates publicly available from the CDC. Secondary outcomes in enrolled patients compared symptom resolution and home exposure, adherence to nasal irrigation, and any impact of irrigation system or antimicrobial or alkalization addition to the irrigant.
Results Of 79 patients assigned to nasal irrigation (63.99[7.96] years, 36[45.6%] female, 43[54.4%]male), 0/37 assigned to povidone-iodine and 1/42 patients in the alkalinization group had a COVID-19 related hospitalization (1.26%). From September 22 to December 21, 2020, in patients 50+ years the CDC reported 1022977 cases with 197777 hospitalizations, or 19.33% (OR:0.054, 95%CI0.0074 to 0.38, p=0.0036). Diaries were completed by 62 patients, averaging 1.79 irrigations/day. There were no statistical differences in outcomes by irrigation unit used, of those with symptoms, resolution was more likely in the povidone-iodine group (19/25) than the alkalinization group (15/33, OR.26 (95%CI 0.084 to 0.83,p=0.022).
Conclusion Patients who initiated isotonic saline nasal irrigation after a positive COVID-19 PCR test were 19 times less likely to be hospitalized than the national rate. Further research is required to determine if adding povidone-iodine to irrigation reduces morbidity and mortality of SARS-CoV-2 infection.
Trial Registration ClinicalTrial.gov Identifier: NCT04559035
Competing Interest Statement
After obtaining permission from the Augusta University Department of Emergency Medicine to pursue funding for the study, I reached out to Georgia and national nonprofits. I was able to get the Community Foundation for Greater Atlanta to provide $10,000, and Rhinosystems Inc to provide NAVAGE units and NeilMed Inc. to provide Sinus Rinse units for the study As I was unable to raise more funding, I went back to Rhinosystems Inc. and NeilMed Inc. who each matched the Community Foundation for Greater Atlanta with $10,000 in unrestricted funds to the National Disaster Life Support Foundation. All physicians and research staff contributed their time pro bono. Neither I nor any of the authors nor Augusta University have prior or ongoing relationships with either Sinus Rinse company. Any hourly staff were compensated by the nonprofit.
Clinical Trial
NCT04559035
Funding Statement
Nasal irrigation systems were provided by Rhinosystems Inc. and Neilmed Inc. For additional materials, patient compensation, and study enrollers The Bernard and Anne Gray Donor Advised Fund Community Foundation for Greater Atlanta, Neilmed Inc., and Rhinosystems Inc. each donated $10,000 in unrestricted funds to the National Disaster Life Support Foundation who supported the study. No authors received external funding or have any prior or ongoing economic relationship with any donors.
https://www.medrxiv.org/content/10.1101/2021.08.16.21262044v1
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