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

{ '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': 'https://creativecommons.org/licenses/by-nc/4.0/'}], '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': ['journals.sagepub.com'], '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': 'http://dx.doi.org/10.1177/sage-journals-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': 'http://orcid.org/0000-0001-7123-0733', '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': 'http://orcid.org/0000-0002-0350-8243', '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': 'http://orcid.org/0000-0003-0947-3034', 'authenticated-orcid': False, 'given': 'Richard', 'family': 'Schwartz', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Emergency Medicine, Augusta University, Augusta, ' 'GA, USA'}]}], 'member': '179', 'published-online': {'date-parts': [[2022, 8, 25]]}, 'reference': [ { 'key': 'bibr1-01455613221123737', 'doi-asserted-by': 'publisher', 'DOI': '10.1038/s41591-020-0868-6'}, { 'key': 'bibr2-01455613221123737', 'doi-asserted-by': 'publisher', 'DOI': '10.1038/d41586-021-02039-y'}, { 'key': 'bibr3-01455613221123737', 'author': 'Li C', 'year': '2021', 'journal-title': 'bioRxiv'}, { 'key': 'bibr4-01455613221123737', 'doi-asserted-by': 'publisher', 'DOI': '10.1038/s41598-018-37703-3'}, { 'key': 'bibr5-01455613221123737', 'first-page': 'Cd013627', 'volume': '9', 'author': 'Burton MJ', 'year': '2020', 'journal-title': 'Cochrane Database Syst Rev'}, { 'key': 'bibr6-01455613221123737', 'doi-asserted-by': 'publisher', 'DOI': '10.1001/jamaoto.2020.1622'}, { 'key': 'bibr7-01455613221123737', 'doi-asserted-by': 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