METHODS:
PATIENTS:
SANI is a web-based observatory collecting demographic, clinical, functional, inflammatory biomarkers data of patients with severe asthma according to European Respiratory Society (ERS)/American Thoracic Society (ATS) classification 11 and aged > 12 years, recruited by accredited centers homogeneously spread out the national territory 12,13. All centers, have been contacted and inquired to report confirmed (i.e. patients with positive test result for the virus SARS-CoV-2 from analysis of nasopharyngeal or oropharyngeal swab specimens) or highly suspect cases of COVID-19 (i.e. patients with symptoms, laboratory findings and lung imaging typical of COVID-19 but without access to nasopharyngeal or oropharyngeal swab specimens because of clinical contingencies/emergency) among their cohorts of severe asthma.
Demographic and clinical data of the entire population of severe asthmatics enrolled in the study and all reported cases of confirmed or suspect cases of COVID-19, have been obtained from the registry platform and collected from the additional Center (Azienda Ospedaliero Univeristaria di Ferrara, Ferrara, Italy). Additional data about COVID-19 symptoms, treatment and clinical course have been collected for all cases reported.
GENERAL INFORMATION ON COVID-19 IN ITALY:
Open access data about the number of confirmed cases of SARS-CoV-2 infected subjects in the Italian general population have been collected from the Civil Protection Department of the Italian Government website1, and used to draw a thematic map representing the number of cases divided by administrative regions.
ETHICAL ISSUES:
The observatory was carried out according to the declarations of Helsinki and Oviedo. The SANI registry was set up according to the 3rd Edition Recommendation on registries for evaluating patient outcomes published by the Effective Health Care Program of the Agency for Healthcare Research and Quality (https://effectivehealthcare.ahrq.gov/topics/registries-guide-3rd-edition/research/). The protocol was performed according to the principles and procedures of the Good Clinical Practice (ICH Harmonized Tripartite Guidelines for Good Clinical Practice 1996; Directive 91/507. EEC, The Rules Governing Medical Products in the European Community) and according to the Italian laws (D.L.vo n.211 del 24 Giugno 2003;D.L.n.200 del 6 Novembre 2007; MD del 21 Dicembre 2007).
STATISTICAL ANALYSIS:
Statistical analysis was performed using SPSS 21.0 software (SPSS, Chicago, IL, USA). The Kolmogorov-Smirnov test was used to evaluate the normality of distribution of each continuous variable, and depending on the result of this test, the Student t-test or Mann-Whitney test was used to compare variables. Categorical variables were compared with the Fisher exact test. A p-value < 0.05 was considered statistically significant.