ABSTRACT
INTRODUCTION: At the end of the first pandemic wave in Italy, late in May 2020, all employees of our public hospital in Turin were invited to a SARS-CoV-2 serological observational study. The study enrolled 1,562 subjects and revealed an overall 9.6% positivity for anti-SARSCoV-2 IgG, with significant differences based on exposure to COVID-19 patients. After the BNT162b2 mRNA vaccine became available in Europe, all hospital workers were invited to vaccination, independently from previous SARS-CoV-2 infection status. AIM and METHODS: All of vaccinated hospital workers were invited to participate to a serologic study focused at exploring short-term serological response (1 month after second vaccine dose), and medium-term serological response (3-months after vaccination), in order to test persistency of the seroconversion, after approval by local Ethical Committee. We used CMIA method for determination of IgG antibodies to SARS-CoV-2, directed against RBD of spike protein, on Alinity platform (Abbott). RESULTS: Interim analysis results (on 1,016 vaccinated workers) showed serological response above the cut-off (50 AU/ mL) in all but 1 case (99.9%), and a valid IgG level (>500 AU/ml) in 1,007 subjects (99.1%). Median IgG titre observed was above such limits: 10,197 AU/ml (95%CI 9,705-10,752). Occurrence of adverse events was significantly more common among patients with prior SARS-CoV-2 infection, as confirmed by previous specific PCR swab (p<0.0001). Anti SARS-CoV-2 IgG levels were significantly higher in patients with positive swabs (n= 137, median 21,327 AU/mL, 95%CI 19,101-24,063;p<0.0001), or seropositivity before vaccination (n=102, median 23,653 AU/mL, 95%CI 20,626-28,292;p<0.0001), or with any self reported adverse event after vaccination (n=586, median 12,179, 95%CI 11,087-12,948;p<0.0001). A SARS-CoV-2 infection was observed in 11 cases (1%) after full immunization (two vaccine doses);none of the positive cases required hospitalization or presented severe symptoms. Finally, median IgG titre observed 3-months after vaccination was 5,625 AU/mL, as expected. CONCLUSION: According to our preliminary results, early COVID infection among vaccinated subjects is rare. Full results of ongoing study will explore the persistency of seroconversion.
ABSTRACT
Background: Coronavirus disease 2019 (COVID-19), had two pandemic waves in 2020, respectively in April and November. In the general population, the first wave has been characterized by a higher prevalence in Northern Italy and a higher mortality rate compared to the second one. The aim of this study was to compare the characteristics of IBD patients and negative outcomes of COVID-19 (pneumonia, hospitalization, ventilatory support, death) between the two pandemic waves in Italy. Methods: Prospective observational cohort study. Patients with diagnosis of IBD and confirmed SARS-CoV-2 infection were enrolled. Differences between first and second wave were tested for significance using the Student's t test and Fisher's test, as appropriate. A two-tailed p value <0.05 was indicative of statistical significance. Results: We enrolled 937 IBD patients from 47 participating IBD centres across Italy (219 in the first wave, 718 in the second wave). There were no significant differences between the first and the second wave in terms of age (46.3 ± 16.0 vs. 44.1 ± 15.5 years, p=0.06) and gender (female 45.7% vs. 48.2%, p= 0.54). In the first wave, a lower percentage of patients was affected by Crohn's disease (CD): 92 (42.0%) vs. 399 (55.6%) (p<0.001) while no differences were observed for disease clinical activity: 97/219 (44.3%) vs. 280/718 (38.9%) in the first and second wave, respectively (p=0.18). Regarding biologic therapy, the percentage of patients on biologics in the two waves was similar: 119/219 (54.3%) vs. 393/718 (54.7%) (p=0.94), without differences in anti-TNFalpha, anti-integrins and anti-IL12/23 distribution. During the first wave, a significantly higher percentage of patients were from Northern Italy compared to Central-Southern Italy: 171/219 (78.1%) vs. 387/718 (53.9%), respectively (p<0.001). Overall, COVID-19 negative outcomes were significantly higher in the first wave compared to the second one: 110 (50.2%) vs. 95 (13.2%), respectively (p<0.001). Also the single negative outcomes were significantly higher in the first wave: 61/219 (27.8%) vs. 84/718 (11.7%) had pneumonia, 62/219 (28.3%) vs. 76/718 (10.6%) required hospitalization, 26/219 (11.9%) vs. 39/718 (5.4%) required ventilatory support, and 12/219 (5.5%) vs. 13/718 (1.8%) died (Figure 1). Conclusion: IBD patients had higher number of COVID-19 negative outcomes in the first wave than in second wave. In the first wave, a significantly higher percentage of patients were from Northern Italy, but no significant differences in negative outcomes were observed in comparison with those from Central- Southern Italy. Overall, findings in IBD population are coherent with those observed in the general population. (Table Presented).
ABSTRACT
Background: In the last year, the severe adult respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic has spread rapidly around the world. The interactions between SARS-CoV-2 and inflammatory bowel disease (IBD) are so far not fully understood. In particular, no studies evaluated the potential role of SARS-CoV-2 on IBD course. Indeed, it is known that viral infections can be act as triggers for IBD flare and it is reasonable that the possible drug discontinuation during SARS-CoV-2 infection could in turn lead to an IBD flare. Methods: This was a prospective, observational case-control study. From March 11th 2020 to June 30th 2020 we enrolled IBD patients with proven SARS-Cov-2 infection (cases) and IBD patients without SARS-CoV-2 infection matched for sex, age, diagnosis, therapy and clinical activity (controls). Cases and controls were followed-up at least for 6 months. Differences between case and control group were tested for significance using the Students t test and Fishers test, as appropriate. A two-tailed p value < 0.05 was indicative of statistical significance. Results: 219 IBD patients (127 UC, 58.0%) with SARS-CoV-2 infection and 219 IBD patients without SARS-CoV-2 infection were enrolled. Table 1 shows baseline features of the population. Among the 122 cases in clinical remission at the time of viral infection, 28 (22.9%) showed a disease flare;this percentage was significantly higher than that observed in controls: 12/137 (8.8%)(p=0.0018). Among patients with disease flare, there were no significant differences between cases and controls group in terms of age (42.3 ± 16.0 vs. 43.1 ± 15.4 years, p=0.44), gender (female 45.7% vs. 48.2%, p= 0.54), use of biologic therapies (p=0.83) and UC or CD diagnosis (p=0.06). Biologic therapy was temporary withdrawn more significantly in cases than in controls (68/202, 33.6% vs. 14/204, 6.9%) (p<0.001) and overall biologic therapy discontinuation was significantly associated with disease flare (OR 2.56, 95% CI 1.026.41, p=0.04). Conclusion: IBD patients with SARS-CoV-2 infection have an increased risk to have a clinical recurrence in short-term in comparison with IBD patients without SARS-CoV-2 infection. This increased risk could be due to the viral infection and/or to the temporary discontinuation of biologic therapies, because of infection.
ABSTRACT
The SARS-CoV-2 outbreak early in 2020 overwhelmed the Italian national health system, and hospitals were considered places at high risk of spreading the infection. We explored specific antibody seroprevalence of all employees at a single hospital in the epicenter of the outbreak, to identify risky pathways and to evaluate the usefulness of antibody testing. Methods: All hospital workers were invited to fill in a questionnaire and undergo a blood test for SARS-CoV-2 IgG, using two commercial tests (DiaSorin and Abbott). The SARSCoV-2 S1/S2 IgG test (DiaSorin, Saluggia, Italy) is a chemiluminescence immunoassay for quantifying antispike 1 (S1) and anti-spike 2 (S2) IgG on the LIAISON XL automated analyzer;according to the manufacturer, a titer <12 AU/ml is negative, from 12 to 15 is equivocal, and >15 is positive;values below 3.8 are undetectable. The SARS-CoV-2 IgG assay (Abbott, Abbott Park, Illinois, USA) is a chemiluminescent microparticle immunoassay for quantifying anti-capsid IgG on the ARCHITECT i System analyzer;according to the manufacturer, a titer <1.4 is negative and >1.4 is positive. Subjects who tested positive for SARS-CoV-2 IgG underwent a confirmatory nasopharyngeal swab PCR test. Seropositivity was determined overall and according to demographic and occupations characteristics, for both tests singly and combined. Results: The study enrolled 1562 hospital workers. Overall, 153 participants (9.8%) were positive for SARS-CoV-2 IgG on DiaSorin test, and 150 (9.6%) were positive on Abbott test;both tests were positive in 123 cases (7.9%) and at least one was positive in 180 cases (11.5%). Factors associated with SARSCoV-2 seropositivity included: Being a smoker, working in Emergency or Medicine Departments, self-reporting a relative with COVID-19 or symptoms suggestive of COVID-19.Conclusion: Seroprevalence for SARS-CoV-2 in this population of hospital workers was overall about 10%, with an excess prevalence in roles and departments associated with contacts with COVID-19 patients.