ABSTRACT
Introduction: Equine hyperimmune serum (F(ab')2 fragments) has been widely used in Argentina in the last 100 years with satisfactory results and an acceptable safety profile in the treatment of accidents with poisonous animals such as snakes (bothrops, chrotalus, elapids) and arthropods (Loxosceles, Latrodectus, Phoneutria and Tityus). These antisera were developed by the National Institute for the production of Biologicals (ANLIS-Malbran) and distributed free of charge in public hospitals in the country. Objective(s): The aims of this study (NCT04913779) is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLISMalbran) as an addition to the standard therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Method(s): A randomized, double-blind controlled clinical study is carried out in 200 patients with COVID-19 requiring oxygen therapy in which the safety and efficacy of early use (72 hours from the onset of symptoms) of the research product is evaluated. The present work corresponds to a preliminary result of the safety and pharmacokinetic analysis in the first 20 patients included. Result(s): 20 initial patients (1:1 treatment: control ratio) were studied. The post-administration follow-up time was 28 days. The pharmacokinetic analysis shows that the research product presents an extracellular volume of distribution, with a median half-life of distribution was 6.3h (10-90% percentiles: 3.4-8.1 h) and half-life of elimination, 121h (10th-90th percentiles: 83-171 h). Neutralizing activity in plasma was correlated with drug concentration. Daily controls were carried out including physical examination, questioning in relation to symptoms presented, and blood extraction for routine laboratory control. No patient reported symptoms consistent with adverse reactions. Although some patients presented mild laboratory alterations (hepatogram, urea, creatinine), in all cases they were alterations that existed prior to the administration of the research product and that improved after treatment. Conclusion(s): Despite the small number of patients studied initially, and the possible masking of an adverse event due to the underlying disease (COVID-19), no significant adverse reactions were evidenced during treatment with the research product. There were no serious reactions and the pharmacokinetic characteristics appear to show a long-acting profile correlated with neutralizing activity in vitro.
ABSTRACT
Introduction: Equine hyperimmune serum (F(ab')2 fragments) has been widely used in Argentina in the last 100 years with satisfactory results and an acceptable safety profile in the treatment of accidents with poisonous animals such as snakes (bothrops, chrotalus, elapids) and arthropods (Loxosceles, Latrodectus, Phoneutria and Tityus). These antisera were developed by the National Institute for the production of Biologicals (ANLIS-Malbraín) and distributed free of charge in public hospitals in the country. Objective: The aims of this study (NCT04913779) is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLIS-Malbraín) as an addition to the standard therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods: A randomized, double-blind controlled clinical study is carried out in 200 patients with COVID-19 requiring oxygen therapy in which the safety and efficacy of early use (72 hours from the onset of symptoms) of the research product is evaluated. The present work corresponds to a preliminary result of the safety and pharmacokinetic analysis in the first 20 patients included. Results: 20 initial patients (1:1 treatment: control ratio) were studied. The post-administration follow-up time was 28 days. The pharmacokinetic analysis shows that the research product presents an extracellular volume of distribution, with a median half-life of distribution was 6.3h (10-90% percentiles: 3.4-8.1 h) and half-life of elimination, 121h (10th-90th percentiles: 83-171 h). Neutralizing activity in plasma was correlated with drug concentration. Daily controls were carried out including physical examination, questioning in relation to symptoms presented, and blood extraction for routine laboratory control. No patient reported symptoms consistent with adverse reactions. Although some patients presented mild laboratory alterations (hepatogram, urea, creatinine), in all cases they were alterations that existed prior to the administration of the research product and that improved after treatment. Conclusion: Despite the small number of patients studied initially, and the possible masking of an adverse event due to the underlying disease (COVID-19), no significant adverse reactions were evidenced during treatment with the research product. There were no serious reactions and the pharmacokinetic characteristics appear to show a long-acting profile correlated with neutralizing activity in vitro.
ABSTRACT
Introduction: Concern about becoming infected is a particularly relevant psychological aspect in the context of a pandemic, as it is associated with social reactions and behavioral changes. Objectives: The present study sought to determine some sociodemographic and health factors associated with concern about COVID-19 infection in Cuban patients with type 2 diabetes mellitus. Methods: 203 patients with type 2 diabetes mellitus, who attended nine primary care areas of four Cuban provinces belonging to different regions of the country (65.52% female, mean age 57.5, SD=19.2), selected through non-probabilistic sampling, participated in the study. A sociodemographic questionnaire, the COVID-19 contagion concern scale (PRE-COVID-19) and an evaluation of blood glucose level were applied. Bivariate associations were examined with a series of analyses of variance (ANOVA). Adjusted (multiple) regression with all predictors running simultaneously was also used. Results: Bivariate analyses showed that age, sex, education, occupation, having comorbidities, and having a family member or friend who had COVID-19 were significantly related to COVID-19 contagion concern. However, when all variables were included simultaneously, only age, technical education, having comorbidities, and having a friend or family member who had COVID-19 remained significant predictors of concern about COVID-19 infection. Conclusions: Male patients, with a technical level of education, with comorbidities and those who had infected family members or friends presented greater concern for the contagion of COVID-19. The public health policies should develop strategies to assess the mental health of people belonging to vulnerable groups and provide interventions to promote mental health in those who show concern about infection.