Rapid initiation of nasal saline irrigation to reduce severity in high-risk COVID+ outpatients
Baxter et al.,
Rapid initiation of nasal saline irrigation to reduce severity in high-risk COVID+ outpatients,
Ear, Nose & Throat Journal, doi:10.1177/01455613221123737 (date from earlier preprint), NCT04559035
Small RCT 79 PCR+ patients 55+ comparing pressure-based nasal irrigation with povidone-iodine and sodium bicarbonate, showing improved recovery with povidone-iodine. Not all results comparing povidone-iodine and sodium bicarbonate are in the journal version, as authors focus on the comparison with CDC data. Earlier versions can be found at
[medrxiv.org]. The reported hospitalization switched groups between the preprint and the journal version.
risk of hospitalization, 213.5% higher, RR 3.14, p = 0.47, treatment 1 of 37 (2.7%), control 0 of 42 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), preprint result reversed.
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risk of no recovery, 56.8% lower, RR 0.43, p = 0.03, treatment 6 of 27 (22.2%), control 18 of 35 (51.4%), NNT 3.4, preprint V2.
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risk of transmission, 13.6% lower, RR 0.86, p = 1.00, treatment 4 of 27 (14.8%), control 6 of 35 (17.1%), NNT 43, preprint V2.
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risk of hospitalization, 94.1% lower, RR 0.06, p = 0.004, nasal irrigation vs. CDC data.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Baxter et al., 17 Aug 2021, Randomized Controlled Trial, USA, peer-reviewed, 12 authors, study period 24 September, 2020 - 21 December, 2020, this trial compares with another treatment - results may be better when compared to placebo, trial
NCT04559035 (history).
Abstract: Clinical Study
Rapid initiation of nasal saline irrigation to
reduce severity in high-risk COVID+
outpatients
Ear, Nose & Throat Journal
2022, Vol. 0(0) 1–10
© The Author(s) 2022
Article reuse guidelines:
sagepub.com/journals-permissions
DOI: 10.1177/01455613221123737
journals.sagepub.com/home/ear
Amy L Baxter, MD1 , Kyle R Schwartz, MPH2, Ryan W Johnson, MPH, MA3,
Ann-Marie Kuchinski, PhD1, Kevin M Swartout, PhD4, Arni S R Srinivasa Rao, PhD5,6,
Robert W Gibson, PhD, FAOTA1, Erica Cherian, MD3, Taylor Giller, BA, BS3 ,
Houlton Boomer, BA1, Matthew Lyon, MD1, and Richard Schwartz, MD1
Abstract
Objective: To determine whether initiating saline nasal irrigation after COVID-19 diagnosis reduces hospitalization and death in highrisk outpatients compared with observational controls, and if irrigant composition impacts severity. Methods: Participants 55 and older
were enrolled within 24 hours of a + PCR COVID-19 test between September 24 and December 21, 2020. Among 826 screened, 79
participants were enrolled and randomly assigned to add 2.5 mL povidone-iodine 10% or 2.5 mL sodium bicarbonate to 240 mL of isotonic
nasal irrigation twice daily for 14 days. The primary outcome was hospitalization or death from COVID-19 within 28 days of enrollment by
daily self-report confirmed with phone calls and hospital records, compared to the CDC Surveillance Dataset covering the same time.
Secondary outcomes compared symptom resolution by irrigant additive. Results: Seventy-nine high-risk participants were enrolled
(mean [SD] age, 64 [8] years; 36 [46%] women; 71% Non-Hispanic White), with mean BMI 30.3. Analyzed by intention-to-treat, by day 28,
COVID-19 symptoms resulted in one ED visit and no hospitalizations in 42 irrigating with alkalinization, one hospitalization of 37 in the
povidone-iodine group, (1.27%) and no deaths. Of nearly three million CDC cases, 9.47% were known to be hospitalized, with an
additional 1.5% mortality in those without hospitalization data. Age, sex, and percentage with pre-existing conditions did not significantly
differ by exact binomial test from the CDC dataset, while reported race and hospitalization rate did. The total risk of hospitalization or
death (11%) was 8.57 times that of enrolled nasal irrigation participants (SE = 2.74; P = .006). Sixty-two participants completed daily surveys
(78%), averaging 1.8 irrigations/day. Eleven reported irrigation-related complaints and four discontinued use. Symptom resolution was
more likely for those reporting twice daily irrigation (X2 = 8.728, P = .0031) regardless of additive. Conclusion: SARS-CoV-2+
participants initiating nasal irrigation were over 8 times less likely to be hospitalized than the national rate.
Keywords
COVID-19, coronavirus, SARS-COV-2, nasal lavage, povidone-iodine
1
Department of Emergency Medicine, Augusta University, Augusta, GA, USA
Edinburgh Napier University, Edinburgh, UK
3
Medical College of Georgia, Augusta University, Augusta, GA, USA
4
Department of Psychology, Georgia State University, Atlanta, GA, USA
5
Laboratory for Theory and Mathematical Modeling, Department of MedicineDivision of Infectious Diseases, Medical College of Georgia, Augusta
University, Augusta, GA, USA
6
Department of Mathematics, Augusta University, Augusta, GA, USA
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