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 significantly lower hospitalization when compared with CDC data.
risk of hospitalization, 65.3% lower, RR 0.35, p = 1.00, treatment 0 of 37 (0.0%), control 1 of 42 (2.4%), NNT 42, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), vs. PVP-I.
risk of hospitalization, 94.1% lower, RR 0.06, p = 0.004, nasal irrigation vs. CDC data.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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+
Ear, Nose & Throat Journal
2022, Vol. 0(0) 1–10
© The Author(s) 2022
Article reuse guidelines:
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
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  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.
COVID-19, coronavirus, SARS-COV-2, nasal lavage, povidone-iodine
Department of Emergency Medicine, Augusta University, Augusta, GA, USA
Edinburgh Napier University, Edinburgh, UK
Medical College of Georgia, Augusta University, Augusta, GA, USA
Department of Psychology, Georgia State University, Atlanta, GA, USA
Laboratory for Theory and Mathematical Modeling, Department of MedicineDivision of Infectious Diseases, Medical College of Georgia, Augusta
University, Augusta, GA, USA
Department of Mathematics, Augusta University, Augusta, GA, USA
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