Objective: To determine whether nasal irrigation initiated within 24 hours of a positive PCR test result reduces hospitalizations for COVID-19. Design, Setting and Participants: Prospective case:cohort trial comparing clinical outcomes in patients aged 55 years or older who were PCR positive at a community testing site in Augusta, Georgia. Patients randomized to initiate one of two nasal irrigation regimens within 24 hours of testing were compared to outcomes in the CDC national database for the same time period. Interventions: Participants were assigned on alternate days to one of two pressure-based nasal irrigation systems (NAVAGE, Rhinosystems Inc.) or Neilmed Sinus Rinse (Neilmed Inc.), and randomized to include 2.5ml povidone-iodine or 0.5 teaspoon sodium bicarbonate to the standard saline rinse twice daily for 14 days with 14-day follow-up. Main Outcomes and Measures: The primary outcome was hospitalization for COVID-19 symptoms within 28 days of enrollment by daily self-report confirmed with phone follow-up and hospital records compared to hospitalization rates publicly available from the CDC. Secondary outcomes in enrolled patients compared symptom resolution and home exposure, adherence to nasal irrigation, and any impact of irrigation system or antiviral or alkalization addition to the irrigant. Of 79 patients assigned to nasal irrigation (63.99[7.96] years, 36[45.6%] female, 43[54.4%]male), 0/37 assigned to povidone-iodine and 1/42 patients in the alkalinization group had a COVID-19 related hospitalization (1.26%). From September 22 to December 21, 2020, in patients 50+ years the CDC reported 1022977 cases with 197777 hospitalizations, or 19.33% (OR:0.054, 95%CI0.0074 to 0.38, p=0.0036). Full daily diaries were completed by 62 patients, averaging 1.79 irrigations/day. There were no statistical differences in symptomatic outcomes by irrigation unit used, but symptom resolution in 14 days was more likely in the povidone-iodine group (21/27) than the alkalinization group (17/35, p=0.019). Conclusion: Patients who initiated mechanical isotonic saline nasal debridement within 24 hours of a positive COVID-19 PCR test were 19 times less likely to be hospitalized than the national rate. Further research is required to determine if adding betadine to irrigation reduces morbidity and mortality of SARS-CoV-2 infection.
Rapid initiation of nasal saline irrigation: hospitalizations in COVID-19 patients randomized to alkalinization or povidone-iodine compared to a national dataset