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

Abstract

Objective 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. 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.

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

“…As of October 1, 2022, 119 preprints (78.3%) had been published in a scientific, peer-reviewed journal (Figure 2 and eTable 3 in Supplement 1). Two preprints were published in a single journal publication . The median time to publication was 186 days (range, 17-407 days).…”

Evaluation of Epigallocatechin-3-Gallate-Palmitate (EC16) in Nasal Formulations Against Human Coronavirus

“…According to the characteristics of SARS-CoV-2 replication in the nasal cavity, investigators studied if saline irrigation (gavage) in the nasal cavity would assist in infection recovery. Indeed, a randomized clinical trial using isotonic saline pressured irrigation, supplemented with either sodium bicarbonate or povidone-iodine, significantly reduced hospitalization rate during the early stage of COVID-19 pandemic [36]. Saline, either isotonic or hypertonic, has been used for respiratory conditions as an economical and effective alternative to medications [37,38].…”

Can nasal irrigation with chlorine dioxide be considered as a potential alternative therapy for respiratory infectious diseases? The example of COVID-19

“…Later, Yildiz et al found that nasal saline irrigation with triamcinolone acetonide may relieve COVID-19-related hyposmia (19). Baxter et al found that nasal irrigation with povidone-iodine or sodium bicarbonate helped to reduce disease severity and the duration of hospitalization in patients with COVID-19 (20). These studies seem to prove the efficacy of nasal irrigation to treat COVID-19.…”