Importance SARS-CoV-2 enters the nasopharynx to replicate; mechanical debridement with nasal irrigation soon after diagnosis could reduce morbidity and mortality.
Objective To determine whether initiating nasal irrigation after COVID-19 diagnosis reduces hospitalizations and death, and whether irrigant composition impacts severity.
Design Unblinded randomized clinical trial of two nasal irrigation protocols in outpatients PCR positive for SARS-CoV-2, nested in a prospective case:cohort using laboratory-confirmed cases in the CDC COVID-19 Case Surveillance dataset.
Setting Single-lab community testing facility associated with the emergency department (ED) in Augusta, GA.
Participants A consecutive sample of outpatients 55 years and older were contacted from daily COVID-19+ lab reports between September 24 and December 21 of 2020. Patients without supplemental oxygen use or cognitive barriers agreeing to same-day irrigation initiation were remotely consented. Among 826 screened, 321 were unable to be reached, 132 were ineligible, 294 refused participation, and 79 participants were enrolled.
Interventions Participants were randomly assigned adding 2.5 mL povidone-iodine 10% or 2.5 mL sodium bicarbonate to 240ml of isotonic nasal irrigation twice daily for 14 days.
Main Outcomes and Measures 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 participants were enrolled (mean [SD] age, 64 [8] years; 36 [46%] women; 71% Non-Hispanic White). Analyzed by intention-to-treat, by day 28, COVID-19 symptoms resulted in 1/42 hospitalizations in those irrigating with alkalinization, 0/37 in the povidone-iodine group, (1.27%) and no deaths. Of nearly three million CDC cases, 9.14% were known to be hospitalized, with an additional 1.5% mortality in those without hospitalization data. The total risk of hospitalization or death (10.6%) was 8.4 times that of enrolled patients (SE=2.74; P=.006). 62 completed daily surveys (78%), averaging 1.8 irrigations/day. Eleven had irrigation complaints, and four discontinued. There were no significant differences by additive.
Conclusion SARS-CoV-2+ participants initiating nasal irrigation were over 8 times less likely to be hospitalized than the national rate.
Trial Registration [ClinicalTrial.gov][1] Identifier: [NCT04559035][2]
Author Approval All authors have filled out ICMJE and approved submission.
Conflict of Interest Statement Materials were provided by Neilmed Inc. and Rhinosystems Inc. The study was supported by funding from the Bernard and Anne Gray Donor Advised Fund Community Foundation for Greater Atlanta, Neilmed Inc., and Rhinosystems. No authors have conflict of interest.
Question After testing positive for COVID-19, will rapidly initiating nasal irrigation with alkaline or povidone-iodine isotonic solution reduce the risk of morbidity and mortality compared to a national dataset?
Findings In this randomized trial of 79 older adults nested in a case:control with the CDC COVID-19 National Dataset, 1.27% of participants initiating nasal irrigation were hospitalized or died, compared to 10.6%, a significant difference.
Meaning In older outpatients testing positive for SARS-CoV-2 who initiated nasal irrigation rapidly after diagnosis, risk of hospitalization or death was eight times lower than national rates reported by the CDC.
### Competing Interest Statement
The authors have declared no competing interest.
### Clinical Trial
NCT04559035
### Funding Statement
Materials were provided by Neilmed Inc. and Rhinosystems Inc. The investigator-initiated study was supported by funding from the Bernard and Anne Gray Donor Advised Fund Community Foundation for Greater Atlanta, Neilmed Inc., and Rhinosystems.
### Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Institutional Review Board Office Augusta University 1120 15th St., CJ-2103 Augusta GA 30912-7621 Email: IRB@augusta.edu Phone: 706-721-3110 http://www.augusta.edu/research/irboffice/
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
Data is available from the University of Augusta Department of Emergency Medicine Research Office, and online from the CDC COVID-19 Case Surveillance Public Use Data
[1]: http://ClinicalTrial.gov
[2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04559035&atom=%2Fmedrxiv%2Fearly%2F2021%2F08%2F25%2F2021.08.16.21262044.atom
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