Safety and Efficacy of Outpatient Treatments for COVID-19: Real-Life Data from a Regionwide Cohort of High-Risk Patients in Tuscany, Italy (the FEDERATE Cohort).

Early COVID-19 treatments can prevent progression to severe disease. However, real-life data are still limited, and studies are warranted to monitor the efficacy and tolerability of these drugs. We retrospectively enrolled outpatients receiving early treatment for COVID-19 in 11 infectious diseases units in the Tuscany region of Italy between 1 January and 31 March 2022, when Omicron sublineages BA.1 and BA.2 were circulating. Eligible COVID-19 patients were treated with sotrovimab (SOT), remdesivir (RMD), nirmatrelvir/ritonavir (NRM/r), or molnupiravir (MOL). We gathered demographic and clinical features, 28-day outcomes (hospitalization or death), and drugs tolerability. A total of 781 patients (median age 69.9, 66% boosted for SARS-CoV-2) met the inclusion criteria, of whom 314 were treated with SOT (40.2%), 205 with MOL (26.3%), 142 with RMD (18.2%), and 120 with NRM/r (15.4%). Overall, 28-day hospitalization and death occurred in 18/781 (2.3%) and 3/781 (0.3%), respectively. Multivariable Cox regression showed that patients receiving SOT had a reduced risk of meeting the composite outcome (28-day hospitalization and/or death) in comparison to the RMD cohort, while no significant differences were evidenced for the MOL and NRM/r groups in comparison to the RMD group. Other predictors of negative outcomes included cancer, chronic kidney disease, and a time between symptoms onset and treatment administration > 3 days. All treatments showed good safety and tolerability, with only eight patients (1%) whose treatment was interrupted due to intolerance. In the first Italian multicenter study presenting real-life data on COVID-19 early treatments, all regimens demonstrated good safety and efficacy. SOT showed a reduced risk of progression versus RMD. No significant differences of outcome were observed in preventing 28-day hospitalization and death among patients treated with RMD, MOL, and NRM/r.

Presumptive treatment or serological screening for schistosomiasis in migrants from Sub-Saharan Africa could save both lives and money for the Italian National Health System: results of an economic evaluation.

BACKGROUND: Schistosomiasis can lead to severe irreversible complications and death if left untreated. Italian and European guidelines recommend serological screening for this infection in migrants from Sub-Saharan Africa (SSA). However, studies on clinical and economic impact of this strategy in the Italian and European settings are lacking. This study aims to compare benefits and costs of different strategies to manage schistosomiasis in migrants from SSA to Italy. METHODS: A decision tree and a Markov model were developed to assess the health and economic impacts of three interventions: (i) passive diagnosis for symptomatic patients (current practice in Italy); (ii) serological screening of all migrants and treating those found positive and (iii) presumptive treatment for all migrants with praziquantel in a single dose. The time horizon of analysis was one year to determine the exact expenses, and 28 years to consider possible sequelae, in the Italian health-care perspective. Data input was derived from available literature; costs were taken from the price list of Careggi University Hospital, Florence, and from National Hospitals Records. RESULTS: Assuming a population of 100 000 migrants with schistosomiasis prevalence of 21·2%, the presumptive treatment has a greater clinical impact with 86.3% of the affected being cured (75.2% in screening programme and 44.9% in a passive diagnosis strategy). In the first year, the presumptive treatment and the screening strategy compared with passive diagnosis prove cost-effective (299 and 595 cost/QALY, respectively). In the 28-year horizon, the two strategies (screening and presumptive treatment) compared with passive diagnosis become dominant (less expensive with more QALYs) and cost-saving. CONCLUSION: The results of the model suggest that presumptive treatment and screening strategies are more favourable than the current passive diagnosis in the public health management of schistosomiasis in SSA migrants, especially in a longer period analysis.

Infection with SARS-CoV-2 Variants Is Associated with Different Long COVID Phenotypes.

COVID-19 has been associated with a broad range of long-term sequelae, commonly referred to as "long-COVID" or "post-COVID-19" syndrome. Despite an increasing body of literature, long COVID remains poorly characterized. We retrospectively analysed data from electronic medical records of patients admitted to the post-COVID-19 outpatient service of the Infectious and Tropical Diseases Unit, Careggi University Hospital, Florence, Italy, between June 2020 and June 2021, 4-12 weeks after hospital discharge. A total of 428 patients, 41% women, median age 64 years, underwent a follow-up visit a median 53 days after hospital discharge. Overall, 76% patients reported at least one persistent symptom, including dyspnoea (37%), chronic fatigue (36%), insomnia (16%), visual disorders (13%) and brain fog (13%). Increasing oxygen support (OR 1.4, 95% CI 1.1-1.8), use of immunosuppressants (OR 6.4, 95% CI 1.5-28) and female sex (OR 1.8, 95% CI 1.1-2.9) were associated with a higher risk of long COVID symptoms. Comparison between symptomatic patients infected in the period March-December 2020 (prevalent circulation of wild-type SARS-CoV-2) with those infected in the period January-April 2021 (prevalent circulation of B.1.1.7 Alpha variant) showed a significant modification in the pattern of symptoms belonging to the neurological and cognitive/emotional categories. Our findings confirmed shortness of breath and chronic fatigue as the most frequent long COVID manifestations, while female sex and severe COVID-19 course were the main risk factors for developing lingering symptoms. SARS-CoV-2 variants may induce different long COVID phenotypes, possibly due to changes in cell tropism and differences in viral-host interaction.

Soluble urokinase Plasminogen Activator Receptor (suPAR) levels are predictive of COVID-19 severity: an Italian experience.

BACKGROUND: The soluble urokinase Plasminogen Activator Receptor (suPAR) has been identified as a reliable marker of COVID-19 severity, helping in personalizing COVID-19 therapy. This study aims to evaluate the correlation between suPAR levels and COVID-19 severity, in relation to the traditional inflammatory markers. METHODS: Sera from 71 COVID-19 patients were tested for suPAR levels using Chorus suPAR assay (Diesse Diagnostica Senese SpA, Italy). suPAR levels were compared with other inflammatory markers: IL-1ß, IL-6, TNF-α, circulating calprotectin, neutrophil and lymphocyte counts, and Neutrophil/Lymphocytes Ratio (NLR). Respiratory failure, expressed as P/F ratio, and mortality rate were used as indicators of disease severity. RESULTS: A positive correlation of suPAR levels with IL-6 (r = 0.479, p = 0.000), TNF-α (r = 0.348, p = 0.003), circulating calprotectin (r = 0.369, p = 0.002), neutrophil counts (r = 0.447, p = 0.001), NLR (r = 0.492, p = 0.001) has been shown. Stratifying COVID-19 population by suPAR concentration above and below 6 ng/mL, we observed higher levels of circulating calprotectin (10.1 µg/mL, SD 7.9 versus 6.4 µg/mL, SD 7.5, p < 0.001), higher levels of P/F ratio (207.5 IQR 188.3 vs 312.0 IQR 127.8, p = 0.013) and higher mortality rate. Median levels of suPAR were increased in all COVID-19 patients requiring additional respiratory support (Nasal Cannula, Venturi Mask, BPAP and CPAP) (6.5 IQR = 4.9) compared to the group at room air (4.6 IQR = 4.2). CONCLUSION: suPAR levels correlate with disease severity and survival rate of COVID-19 patients, representing a promising prognostic biomarker for the risk assessment of the disease.

Hospitalization for Chagas disease, dengue, filariasis, leishmaniasis, schistosomiasis, strongyloidiasis, and Taenia solium taeniasis/cysticercosis, Italy, 2011-2016.

PURPOSE: To analyze epidemiology and burden of Neglected Tropical Diseases (NTDs) in Italy. METHODS: We used Hospital Discharge Records and number of residents in Italy to calculate number and rate of hospitalization for Chagas disease, dengue, filariasis, leishmaniasis, schistosomiasis, strongyloidiasis, Taenia solium taeniasis, and cysticercosis by sex, citizenship group, and region in the period 2011-2016. RESULTS: 7195 hospitalizations for NTDs were retrieved, accounting for 7375 diagnoses, 60% in Italians and 40% in foreigners. Male-to-female ratio was 2; the age group more commonly affected was 25-44 years (32.5%). The most common diagnoses were leishmaniasis (34%), schistosomiasis (29%), strongyloidiasis (12%), Chagas disease (8%), and dengue (8%). Average yearly hospitalization rate per 100,000 residents for all NTDs was 2.05, 1.33, and 10.39 in general population, Italians, and foreign citizens, respectively. Hospitalization rates higher than 100 per 100,000 subjects were found in citizens from Sub-Saharan Africa (SSA) and Bolivia. CONCLUSIONS: NTDs have a not negligible burden in Italy. The most clinically relevant NTDs in Italy are leishmaniasis and schistosomiasis, followed by strongyloidiasis, Chagas disease, and dengue. Cystic echinococcosis, that was not included in the analysis since a similar study on this disease was recently published, should also be listed among the leading NTD in Italy. While schistosomiasis has its highest burden on population coming from highly endemic areas such as SSA, leishmaniasis is especially relevant in Italian-born residents of southern regions. Education at university and post-graduate levels, to increase the awareness of healthcare professionals on these topics, as well as targeted public health interventions (such as screening or presumptive treatment in high-risk groups), are an asset to improve clinical management and control of these diseases.

Threatening drug-drug interaction in a kidney transplant patient with coronavirus disease 2019 (COVID-19).

During the novel coronavirus pandemic, organ transplant recipients represent a frail susceptible category due to long-term immunosuppressive therapy. For this reason, clinical manifestations may differ from general population and different treatment approaches may be needed. We present the case of a 36-year-old kidney-transplanted woman affected by Senior-Loken syndrome diagnosed with COVID-19 pneumonia after a contact with her positive mother. Initial symptoms were fatigue, dry cough, and coryza; she never had fever nor oxygen supplementation. Hydroxychloroquine and lopinavir/ritonavir were started, and the antiviral drug was replaced with darunavir/cobicistat after 2 days for diarrhea. Immunosuppressant levels were closely monitored, and we observed very high tacrolimus trough levels despite initial dose reduction. The patient was left with steroid therapy alone. The peculiarity of clinical presentation and the management difficulties represent the flagship of our case report. We stress the need for guidelines in transplant recipients with COVID-19 infection with particular regard to the management of therapy.

Ultrasound findings in urogenital schistosomiasis: a pictorial essay.

Urogenital schistosomiasis is a parasitic disease caused by S. haematobium which is endemic in tropical and sub-tropical areas but is increasingly diagnosed in temperate non-endemic countries due to migration and international travels. Early identification and treatment of the disease are fundamental to avoid associated severe sequelae such as bladder carcinoma, hydronephrosis leading to kidney failure and reproductive complications. Radiologic imaging, especially through ultrasound examination, has a fundamental role in the assessment of organ damage and follow-up after treatment. Imaging findings of urinary tract schistosomiasis are observed mainly in the ureters and bladder. The kidneys usually appear normal until a late stage of the disease.

No Confirmed Cases of Taenia solium Taeniasis in a Group of Recently Arrived Sub-Saharan Migrants to Italy.

One-hundred and sixty-four migrants from Sub-Saharan Africa to Italy were screened with the Taenia solium specific enzyme-linked immunosorbent assay coproantigen (ELISA CoAg) and four (2.4%) were recorded as positive, but with optical density values near to the cut-off. No ELISA CoAg positive samples were confirmed by parasitological methods. Low positivity could be attributed to false positive result or cross-reaction with other Taenia species. Further studies are needed to assess the role of migration on sporadic autochthonous transmission of T. solium taeniasis/cysticercosis in Europe.