Salivary molecular tests for the diagnosis of SARS-CoV-2 infection: an experimental monitoring approach in Italian schools throughout the 2021-2022 school year

Introduction: The widespread of SARS-CoV-2 infection has raised concerns about the potential role of schools in community transmission. In Italy, a national screening test strategy was implemented throughout the 2021-2022 school year to monitor virus circulation in schools. Materials and methods The National Plan for Monitoring the circulation of SARS-CoV-2 virus in primary and secondary schools aims at testing students attending a sample of primary and secondary schools in each Italian Region, by means of molecular salivary testing, every two weeks. We report preliminary data for the period 13/9/2021-13/2/2022 comparing them with the trend of the incidence rate in the Italian population aged 6-13 years. Results A total of 486,206 students from across the country were invited for the screening 273,738 (55.3%) underwent the test and 1086 (0.40%) came back positive. The highest participation rate (> 60%) was recorded on January 2022. Incidence rate was low (< 5 x 10,000 students tested) between September and December 2021, it increased steadily on January 2022 (20.8 x 10,000) and it began to slowly decrease on February 2022. A similar trend was recorded in general population. Of note, a national average of 10% of tests performed on saliva gave indeterminate results. Discussion and conclusions The heterogeneous adherence of Regions to the Plan, the low testing acceptance by students and the high rate of indeterminate results suggest that saliva sampling should be considered carefully when planning a screening campaign in schools. Screening tests in schools emerged as a useful strategy in detecting and contrasting the spread of SARS-CoV-2, but more research is needed on the determinants of student participation and saliva sampling methods.

Humoral, cellular, clinical responses and safety of two doses of SARS-CoV-2 Messenger RNA vaccine in patients with compensated and decompensated cirrhosis: a long-term single center prospective study

Background and Aims: SARS-CoV-2 mRNA vaccines have been approved to prevent COVID-19. We assessed immunogenicity, effectiveness and safety of vaccines in patients with compensated and decompesated cirrhosis. Method: This is a prospective single center study assessing humoral and cellular responses in cirrhotics compared to healthy controls, incidence post-vaccination SARS-CoV-2 infections and adverse events (AEs). Antibodies against the spike- and nucleocapside-protein (anti-S and anti-N) were tested at baseline, 21 days after the first and second doses and during follow-up. Spike-specific T-cells quantity assessment was longitudinally conducted by the stimulation of whole blood with peptides covering the SARS-CoV-2 spike protein, followed by IFN-γ and IL-2 measurement. Results: 182 cirrhotics (61 years, 75% males, 45% viral-related, 74% Child-Pugh A, 31% HCC, 85% COVID-19 naïve) and 38 healthy subjects were enrolled. Previous SARS-CoV-2 infection predicted higher anti-S titres at all time points after vaccination, in both groups. COVID-19 naïve cirrhotics showed significantly lower anti-S titres compared to controls [998.5 (0.4-12,500) vs 1,520 (259-12,500) U/mL, p=0.048], anti-S titres significantly decreased after a median of 133 (70-182) days [536 (0.4-8,777) U/mL, p<0.0001] and were lower in decompensated vs compensated cirrhosis [632 (0.4-12,500) vs 1,377 (0.4-12,500) U/mL, p=0.028]. By multivariable analysis in COVID-19 naïve cirrhotics, independent predictors of lower anti-S were active HCC, immunocompromised conditions, BNT162b2 and lower anti-S after first dose. The spike-specific T-cell response was evaluated in 14 cirrhotics, showing a heterogeneous magnitude of response, but on average the quantity and kinetics of decline of the spike-specific cellular responses diverged in cirrhotics compared to controls, with lower concentrations of both IFN-γ and IL-2. During follow-up, 4/133 (3%) COVID-19 naïve cirrhotics tested positive for anti-N, all asymptomatic. Neither unexpected nor severe AEs emerged. Conclusion: Humoral and cellular responses to SARS-CoV-2 mRNA vaccines appeared suboptimal in patients with cirrhosis, however the rate of post-vaccination infection seems low.

Bowel Perforation in Covid-19 Case Series

OBJECTIVE: To describe the clinical characteristics and outcomes of patients with coronavirus disease 2019(COVID-19) who developed bowel perforation. MATERIALS AND METHODS: This case series was conducted in Emergency Department of AORN Sant'Anna and S. Sebastiano located in Caserta. All patients resulted positive to SARS-Cov-2 in nasopharyngeal swabs whith a positive laboratory test for SARS-CoV-2 from real time reverse transcription polymerase chain reaction(RT-PCR) as well as bowel perforation which was identified by abdominal CT, from September 2020 to December 2020. RESULTS: A total of five patients were identified with Bowel perforation occurred despite all patients being on anticoagulation. All patients were Italian, predominantly male(four patients) with an average age of 60 years and the most common comorbidity was hypertension, diabetes and obesity. DISCUSSION: Bowel perforation in COVID-19 is clinically significant with high morbidity and mortality. In our series 40% of patients who were diagnosed of bowel perforation died. Average time to death after bowel perforation diagnosis was 6 days. CONCLUSION: We describe a case series of COVID-19 patients who developed bowel perforation. KEY WORDS: Covid-19, Bowel perforation.

Spontaneous Pneumomediastinum without Pneumothorax in Non-ventilated COVID-19 Pneumonia: A Case Report

Spontaneous pneumomediastinum (SPM) is among the rare complications of Coronavirus Disease-19 (COVID-19) and usually involves patients with a severe form of disease who are undergoing treatment with invasive/non-invasive ventilation or high-flow oxygen therapy. A very low percentage of SPM cases are detected in non-ventilated COVID-patients, the underlying causes of which are still to be understood. We report here on the case of a 65-year-old patient with no clinical history of cardiovascular or pulmonary disease who developed SPM within a few days following hospital admission. SPM was detected on chest CT-angiography, and was unrelated to high-flow oxygen treatment.

Patient preferences, treatment satisfaction and quality of life in newly diagnosed and relapsed/refractory multiple myeloma patients receiving injectable-containing or fully oral therapies: The EASEMENT study

Content: As multiple myeloma (MM) therapies advance, understanding patients', caregivers' and physicians' perspectives on, and satisfaction with, available treatment options, and the impact of these options on quality of life (QoL), is important. EASEMENT is a real-world, observational, cross-sectional study conducted in the UK, Canada and Italy using retrospective chart reviews and surveys. The primary objectives were to describe patient and caregiver QoL (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L]), patient preference for oral or injectable therapies (single discrete-choice question) and patient satisfaction (Treatment Satisfaction Questionnaire for Medication-9 items [TSQM-9];convenience, effectiveness and global satisfaction subscales;score range 0 100, indicating lower-to-higher satisfaction) by newly diagnosed MM (NDMM) or relapsed/refractory MM (RRMM) status and by investigator-classified treatment injectable-containing ( injectables') versus fully oral ( orals'). A secondary objective was to compare direct healthcare resource utilisation (HRU) between injectable and oral treatments. Descriptive/unadjusted data are presented. 399 patients were enrolled, including 192 NDMM and 206 RRMM patients (status missing for 1 patient). Median age was 71 years (interquartile range 64 76), 61% were male, 74% were retired, 24% had an Eastern Cooperative Oncology group performance status ?2 and 51%/41% were/were not living with their caregiver (8% missing). At the time of study visit, among NDMM patients, 77% were receiving injectables and 23% orals (treatment regimens are summarised in the Table). 9% of NDMM patients preferred injectables and 34% orals (52% no preference, 5% missing). Among RRMM patients, 42% were receiving injectables and 58% orals (treatment regimens are summarised in the Table). 3% of RRMM patients preferred injectables and 55% orals (34% no preference, 7% missing). There were no differences in treatment satisfaction between NDMM and RRMM patients. Results from the TSQM domains are reported for injectables versus orals, respectively;mean convenience score was significantly lower (74.7 vs 78.3;P = 0.0414);mean TSQM perception of effectiveness (72.4 vs 74.7;P = 0.3857) and global satisfaction (72.1 vs 74.2;P = 0.1948) scores did not differ. QoL dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) were not significantly different between NDMM and RRMM patients or between patients receiving injectables or orals. When patients were asked to rate their health on a visual analogue scale (range 0, worst imaginable health, to 100, best imaginable health, as perceived by patients), mean score was significantly higher in NDMM versus RRMM patients (68.0 vs 63.1, P = 0.0313), but similar between patients receiving injectables versus orals (65.0 vs 66.2, P = 0.9069). Preliminary HRU data suggest that the rate of outpatient visits related to MM and its complications was numerically higher among patients receiving injectables versus orals (2.6 vs 2.3 outpatient visits per patient during the last 6 months or since RR disease). EASEMENT data indicate patients' perceived greater convenience with orals versus injectables and that more patients prefer orals versus injectables. Patients receiving orals versus injectables required a numerically lower rate of outpatient visits. Orals are useful options for patients who cannot, or prefer not to, travel to clinics, especially in the context of the COVID-19 pandemic.