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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 65% Improvement Relative Risk Hospitalization, vs. CDC 94% Sodium Bicarbonate  Baxter et al.  EARLY TREATMENT  RCT Is early treatment with sodium bicarbonate beneficial for COVID-19? RCT 79 patients in the USA (September - December 2020) Trial compares with PVP-I, results vs. placebo may differ Trial underpowered to detect differences Significantly lower hospitalization vs. CDC data Baxter et al., Ear, Nose & Throat J., Aug 2022 Favorssodium bicarbonate FavorsPVP-I 0 0.5 1 1.5 2+
37th treatment shown to reduce risk in May 2022
*, now with p = 0.00015 from 7 studies.
Lower risk for mortality, hospitalization, and recovery.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 77 treatments.
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.
6 studies use direct respiratory tract administration1-6
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 sodium bicarbonate and povidone-iodine.
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., 25 Aug 2022, 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). Contact:, @AmyBaxterMD.
This PaperSodium Bicarb..All
{ 'indexed': {'date-parts': [[2022, 8, 25]], 'date-time': '2022-08-25T19:12:04Z', 'timestamp': 1661454724062}, 'reference-count': 49, 'publisher': 'SAGE Publications', 'license': [ { 'start': { 'date-parts': [[2022, 8, 25]], 'date-time': '2022-08-25T00:00:00Z', 'timestamp': 1661385600000}, 'content-version': 'unspecified', 'delay-in-days': 0, 'URL': ''}], 'funder': [ {'name': 'Bernard and Anne Gray Donor Advised Fund'}, {'name': 'Neilmed Inc.', 'award': ['Supplied Materials']}, { 'DOI': '10.13039/100010716', 'name': 'Community Foundation for Greater Atlanta', 'doi-asserted-by': 'publisher'}, {'name': 'Rhinosystems Inc.', 'award': ['Supplied Materials']}], 'content-domain': {'domain': [''], 'crossmark-restriction': True}, 'abstract': '<jats:sec><jats:title>Objective</jats:title><jats:p> To determine whether initiating saline ' 'nasal irrigation after COVID-19 diagnosis reduces hospitalization and death in high-risk ' 'outpatients compared with observational controls, and if irrigant composition impacts ' 'severity. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Participants ' '55 and older were enrolled within 24\xa0hours 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\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. 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<jats:sup>2</jats:sup> = 8.728, P = .0031) ' 'regardless of additive. ' '</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> SARS-CoV-2+ ' 'participants initiating nasal irrigation were over 8 times less likely to be hospitalized ' 'than the national rate. </jats:p></jats:sec>', 'DOI': '10.1177/01455613221123737', 'type': 'journal-article', 'created': {'date-parts': [[2022, 8, 25]], 'date-time': '2022-08-25T18:40:10Z', 'timestamp': 1661452810000}, 'page': '014556132211237', 'update-policy': '', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Rapid initiation of nasal saline irrigation to reduce severity in high-risk COVID+ outpatients', 'prefix': '10.1177', 'author': [ { 'ORCID': '', 'authenticated-orcid': False, 'given': 'Amy L', 'family': 'Baxter', 'sequence': 'first', 'affiliation': [ { 'name': 'Department of Emergency Medicine, Augusta University, Augusta, ' 'GA, USA'}]}, { 'given': 'Kyle R', 'family': 'Schwartz', 'sequence': 'additional', 'affiliation': [{'name': 'Edinburgh Napier University, Edinburgh, UK'}]}, { 'given': 'Ryan W', 'family': 'Johnson', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical College of Georgia, Augusta University, Augusta, GA, ' 'USA'}]}, { 'given': 'Ann-Marie', 'family': 'Kuchinski', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Emergency Medicine, Augusta University, Augusta, ' 'GA, USA'}]}, { 'given': 'Kevin M', 'family': 'Swartout', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Psychology, Georgia State University, Atlanta, GA, ' 'USA'}]}, { 'given': 'Arni S R', 'family': 'Srinivasa Rao', 'sequence': 'additional', 'affiliation': [ { 'name': 'Laboratory for Theory and Mathematical Modeling, Department of ' 'Medicine-Division of Infectious Diseases, Medical College of ' 'Georgia, Augusta University, Augusta, GA, USA'}, { 'name': 'Department of Mathematics, Augusta University, Augusta, GA, ' 'USA'}]}, { 'given': 'Robert W', 'family': 'Gibson', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Emergency Medicine, Augusta University, Augusta, ' 'GA, USA'}]}, { 'given': 'Erica', 'family': 'Cherian', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical College of Georgia, Augusta University, Augusta, GA, ' 'USA'}]}, { 'ORCID': '', 'authenticated-orcid': False, 'given': 'Taylor', 'family': 'Giller', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical College of Georgia, Augusta University, Augusta, GA, ' 'USA'}]}, { 'given': 'Houlton', 'family': 'Boomer', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Emergency Medicine, Augusta University, Augusta, ' 'GA, USA'}]}, { 'given': 'Matthew', 'family': 'Lyon', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Emergency Medicine, Augusta University, Augusta, ' 'GA, USA'}]}, { 'ORCID': '', 'authenticated-orcid': False, 'given': 'Richard', 'family': 'Schwartz', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Emergency Medicine, Augusta University, Augusta, ' 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