Background Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients. Methods A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival. Results In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6–24.0, P = 0.52) and 22.4% (97.5% CI: 17.2–28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline. Conclusions Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline. Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).

RD is a common self-limited disorder, more frequent in the elderly, which may occur after the physical treatment for BPPV. The DHI score at the time of BPPV diagnosis represents a useful tool to quantify the impact of this vestibular disorder on the quality of life and to estimate the risk of RD after CRPs.

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Presentation schedule is subject to change. For the most up-to-date information, visit www.entnet.org/annual_meeting. Conclusions: There is a higher treatment success in patients treated surgically. There is no significant correlation between AAR and NOSE scale and VAS. This is considered because the AAR and subjective scales are complementary and they measure different aspects of NO. Therefore, the AAR and the NOSE scale are helpful instruments to be used together for the diagnosis of NO and to measure objective therapeutic success and the feeling of satisfaction by the patient.Objectives: (1) Quantify the changes in the number of ciliated cells, ciliary beat frequency, and mucociliary transport of the nasal mucosa in smokers.(2) Evaluate if these cytologic and functional changes in smokers are permanent or reversible after smoking cessation.Methods: Ninety healthy volunteers recruited from the staff of A. Fiorini Hospital, Sapienza University of Rome, were enrolled in this study from September 2013 to January 2014. Volunteers were divided into 3 groups (smokers, nonsmokers, and ex-smokers) composed of 30 subjects each. Cytological features of nasal mucosa and effectiveness of nasal mucociliary clearance were studied focusing on 4 parameters: 1) ratio between the number of ciliated cells and mucous-secreting cells analyzed through microscopic observation of nasal scraping specimens; 2) in vitro evaluation of ciliary motility; 3) survival time of the ciliated cells analyzed by phase-contrast microscopy; 4) nasal mucociliary clearance assessed by saccharin transit time test.Results: All parameters are significantly reduced in the group of smokers compared to the nonsmokers (P < .05). However, there are no statistically significant differences between the nonsmoker and ex-smoker groups (P > .05).Conclusions: Cigarette smoking causes cytological modifications of nasal mucosa that influence the effectiveness of mucociliary clearance. Our study, although preliminary and conducted on a limited number of cases, suggests that these changes are not permanent and that nasal mucosa of ex-smokers would recover normal cytologic and functional features. Early versus Delayed Endoscopic Sinus Surgery in Patients withChronic Rhinosinusitis: Impact on Health Care utilization Michael S. Benninger, MD (presenter); Chantal E. Holy, PhD; Raj Sindwani, MD; Claire Hopkins, MD, FRCS Objectives: Using a patient cohort with chronic rhinosinusitis (CRS) refractory to medical management, evaluate the impact of early versus delayed endoscopic sinus surgery (ESS) in terms of postoperative health care utilization. Methods: The MarketScan CCAE database was queried. Patients with ESS in 2010 and complete medical history from 2004 to 2012 were identified. Diagnoses of CRS or polyposis prior to 2005 as well as ESS prior to 2010 were exclusion criteria. Patients were characterized by time interval of first CRS diagnosis to ESS and grouped as follows: (1) <1 year (N = 888); (2) 1-2 years (N = 267); (3) 2-3 years (N = 300); (4) 3-4 years (N = 414);...