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.

[Which screening for Leishmania infantum in asymptomatic blood donors?]. / Leishmania infantum e donatori di sangue: quale screening?

Leishmaniasis is a protozoan infection endemic in Italy with a greatly underestimated prevalence. The recent documentation of parasitaemia in blood donors is a cause of concern for blood safety. Because there is no screening against leishmania, we performed a study to assess the presence of protozoa in blood donors of Siena district (Tuscany) during the seasonal activity of the vector. From June to October 2007, 162 patients were screened for Leishmania infantum by indirect immunofluorescence serology (IFAT) and PCR for kinetoplast (kDNA). No subject was positive for antibodies, while 11 samples (6.8%) were positive for kDNA. A second PCR (nested-PCR) was negative for all kDNA positive individuals and other subjects for a total of 55 samples (33% of total subjects). The sequence analysis of three samples positive for kDNA was compatible with mitochondrial DNA. Through the techniques used, we were unable to confirm the presence of leishmania in the blood of the subjects studied. The choice of the diagnostic protocol in blood donors remains an open issue as molecular analysis (kDNA) seems to suggest, in our experience, limits of specificity.