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All Studies   Meta Analysis    Recent:   

Rapid initiation of nasal saline irrigation to reduce severity in high-risk COVID+ outpatients

Baxter et al., Ear, Nose & Throat Journal, doi:10.1177/01455613221123737, NCT04559035
Aug 2022  
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Hospitalization -214% Improvement Relative Risk Recovery 57% Transmission 14% Hospitalization, vs. CDC 94% Povidone-Iodine  Baxter et al.  EARLY TREATMENT  RCT Is early treatment with povidone-iodine beneficial for COVID-19? RCT 79 patients in the USA (September - December 2020) Trial compares with sodium bicarbonate nasal irrigation Improved recovery with povidone-iodine (p=0.034) c19early.org Baxter et al., Ear, Nose & Throat J., Aug 2022 Favorspovidone-iodine Favorssodium bicar.. 0 0.5 1 1.5 2+
PVP-I for COVID-19
13th treatment shown to reduce risk in February 2021
 
*, now with p = 0.000000004 from 21 studies.
Lower risk for mortality, cases, and viral clearance.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 81 treatments. c19early.org
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 at1. The reported hospitalization switched groups between the preprint and the journal version.
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
Study covers alkalinization, sodium bicarbonate, and povidone-iodine.
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.
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.
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.
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., 25 Aug 2022, Randomized Controlled Trial, USA, peer-reviewed, 12 authors, study period 24 September, 2020 - 21 December, 2020, average treatment delay 4.0 days, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04559035 (history). Contact: abaxter@augusta.edu, @AmyBaxterMD.
This PaperPovidone-Iod..All
Rapid initiation of nasal saline irrigation to reduce severity in high-risk COVID+ outpatients
MD Amy L Baxter, MPH Kyle R Schwartz, MPH, MA Ryan W Johnson, PhD Ann-Marie Kuchinski, PhD Kevin M Swartout, Arni S R Srinivasa Rao, PhD, FAOTA Robert W Gibson, MD Erica Cherian, BA Taylor Giller, BA Houlton Boomer, MD Matthew Lyon, MD Richard Schwartz
Ear, Nose & Throat Journal, doi:10.1177/01455613221123737
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 (X 2 = 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.
Ethical approval The study was approved by the institutional review board at Augusta University in Augusta, Georgia and was registered at Clinical-Trials.gov NCT04559035. Informed consent Verbal informed consent was obtained from the patient(s) for their anonymized information to be published in this article. ORCID iDs Amy L Baxter  https://orcid.org/0000-0001-7123-0733 Taylor Giller  https://orcid.org/0000-0002-0350-8243 Richard Schwartz  https://orcid.org/0000-0003-0947-3034 Supplemental Material Supplemental material for this article is available online.
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Among 826 screened, 79 participants were enrolled and randomly ' 'assigned to add 2.5\xa0mL povidone-iodine 10% or 2.5\xa0mL sodium bicarbonate to 240\xa0mL of ' 'isotonic nasal irrigation twice daily for 14\xa0days. The primary outcome was hospitalization ' 'or death from COVID-19 within 28\xa0days 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. ' '</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> 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. 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