Background
Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients.
Methods
A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival.
Results
In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6–24.0, P = 0.52) and 22.4% (97.5% CI: 17.2–28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline.
Conclusions
Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline.
Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).
NHL is already present at CD diagnosis in most cases in individuals aged 50 and older, emphasizing the importance of early diagnosis. Older and younger individuals are equally adherent and equally benefit from a GFD, indicating that older age is not a barrier to dietary treatment.
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Post-SARS-CoV-2 telogen effluvium has been described in case reports of COVID-19 patients. We evaluated the prevalence of post-SARS-CoV-2 telogen effluvium in patients from a single medical center, exploring any causal links with the infection. Our hospital-based, cross-sectional study was conducted with patient participants discharged with a diagnosis of SARS-CoV-2 pneumonia from 1 March to 4 April 2020. All patients were evaluated by the same senior dermatologist; a clinical/dermatoscopic evaluation was performed. Alopecia was assessed in 31.3% of patients, with a significant difference in sex (females 73%, males 26.7%). The average time detected from the onset of the first symptoms to alopecia was 68.43 days. Overall, there were no significant associations between alopecia and COVID-19-related features (length of hospitalization, virologic positivity, or duration of fever), treatment characteristics, or laboratory findings. In this paper, we report that post-infection acute telogen effluvium occurs in a significant number of COVID-19 patients. The burden of this condition may impair the quality of life, with a significant impact on individuals.
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