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Male sex was repeatedly identified as a risk factor for death and intensive care admission. However, it is yet unclear whether sex hormones are associated with disease severity in COVID-19 patients. In this study, we analysed sex hormone levels (estradiol and testosterone) of male and female COVID-19 patients ( n = 50) admitted to an intensive care unit (ICU) in comparison to control non-COVID-19 patients at the ICU ( n = 42), non-COVID-19 patients with the most prevalent comorbidity (coronary heart diseases) present within the COVID-19 cohort ( n = 39) and healthy individuals ( n = 50). We detected significantly elevated estradiol levels in critically ill male COVID-19 patients compared to all control cohorts. Testosterone levels were significantly reduced in critically ill male COVID-19 patients compared to control cohorts. No statistically significant differences in sex hormone levels were detected in critically ill female COVID-19 patients, albeit similar trends towards elevated estradiol levels were observed. Linear regression analysis revealed that among a broad range of cytokines and chemokines analysed, IFN-γ levels are positively associated with estradiol levels in male and female COVID-19 patients. Furthermore, male COVID-19 patients with elevated estradiol levels were more likely to receive ECMO treatment. Thus, we herein identified that disturbance of sex hormone metabolism might present a hallmark in critically ill male COVID-19 patients.

Background: Japanese encephalitis remains a serious health concern in Asian countries and has sporadically affected pediatric travelers. In the present study, we monitored the safety profile of the Japanese encephalitis virus vaccine IXIARO (Valneva Austria GmbH, Vienna, Austria) in a pediatric population., Methods: We randomized 1869 children between 2 months and 17 years of age in an age-stratified manner to vaccination with IXIARO or one of the control vaccines, Prevnar (formerly Wyeth Pharmaceuticals Inc., now Pfizer Inc., Kent, United Kingdom) and HAVRIX 720 (GlaxoSmithKline Biologicals, Rixensart, Belgium). Adverse events (AEs) (unsolicited and solicited local and systemic AEs), serious AEs and medically attended AEs were assessed up to day 56 and month 7 after the first dose., Results: Incidences of AEs, serious AEs or medically attended AEs did not differ significantly between the groups in any age stratum. AEs were most frequent in children <1 year of age and decreased with age. AEs of special interest, predefined as AEs associated with potential hypersensitivity/allergy or neurologic disorders up to day 56, were reported in 4.6% (IXIARO) versus 6.3% (Prevnar) in the ≥2 months to <1 year age group and 3.4% (IXIARO) versus 3.3% (HAVRIX) in the ≥1 to <18 years age group. Fever, the most frequent systemic reaction in 23.7% of infants to 3.8% of adolescents, decreased with age and did not differ between groups., Conclusions: The safety profile of IXIARO was comparable to the control vaccines in terms of overall AE rates, serious AEs and medically attended AEs.

Objective: To determine the publication rate among pharmacy resident research projects in a region of the United States and to compare characteristics of published and unpublished projects., Methods: Research project abstracts from the Great Lakes Pharmacy Residency Conference in 2003, 2005, and 2007 were reviewed. Two independent investigators collected all study data. Data on residency year, state, institution, study design, and whether results were reported were extracted from available abstracts. Publication rate was determined systematically using a search algorithm within the following databases: Scopus, International Pharmaceutical Abstracts (IPA), and MEDLINE (PubMed). Kappa-statistic was used to determine inter-rater variability. Descriptive statistics were used to analyze nominal and continuous data. Univariate and multivariate regression analyses were used to determine characteristics of publication success. Sensitivity analysis was performed on projects that were successfully published., Results: Information was extracted from 655 abstracts in which 76 abstracts were published (11.4%). Publication rate trended down over the three years analyzed (2003=12.9%, 2005=12.2%, 2007=9.9%; p=0.57). Study design (interventional, observational, cross-sectional, or service development, p=0.115), direction of inquiry (prospective or retrospective; p=0.146), intervention of interest (drug, human, or other; p=0.096), results in abstract (p=0.096), and institution type (university-affiliated, veterans affairs, community-hospital, or retail; p=0.001) were entered into the multivariate model. Cross-sectional design (odds ratio (OR) 3.6), human (OR 1.9) and other (OR 2.1) interventions, as well as university-affiliated residency (OR 2.6) remained significant for publication success. The mean time to publication from abstract to presentation was 24.5 months, and 83% of projects were published within pharmacy journals., Conclusion: Publication rate of pharmacy resident research projects presented at the Great Lakes Pharmacy Residency Conference is low, but it is consistent with other regions of the United States. Study design and study outcomes may influence chance of project publication as well as institution-type, which may have unique research resources, training, and mentorship.