Safety and efficacy of apremilast in adults hospitalized with COVID-19

Introduction: Apremilast, a nonbiologic oral phosphodiesterase 4 (PDE4) inhibitor, was evaluated as a treatment for the hyperinflammatory response in patients (pts) hospitalized with severe COVID-19. Aims and Objectives: To assess the safety and effectiveness of apremilast plus standard of care (SoC) in pts hospitalized with severe COVID-19. Method(s): COMMUNITY (EudraCT 2020-002594-10) was a phase 3, double-blind, randomized, multinational, platform trial in adult pts hospitalized with COVID-19. Pts received apremilast 30 mg BID (APR) or placebo (PBO) for 14 days or until hospital discharge, whichever occurred first. Supportive care (per study center practices) was allowed except for CYP3A inducers and concurrent PDE4 antagonists. Result(s): From November 24, 2020 to June 4, 2021, 384 pts were enrolled (APR+SoC: n=194;PBO+SoC: n=190);enrollment halted early due to futility. Mean age was 56.5 years;59% were men. Most pts had a COVID-19 clinical severity score of 4 (48%) or 3 (29%) (range: 1-8, 1=death). Median (95% CI) time to confirmed clinical recovery through Day 29 (primary endpoint) was 14 (11-15) days for both groups (P=0.8779). All-cause mortality incidence rates through Day 29 (key secondary endpoint) were 18% (APR+SoC) and 17% (PBO+SoC) (P=0.9665). Treatmentemergent adverse event (TEAE) rates were similar between APR+SoC (54%;n=189) and PBO+SoC (55%;n=187) groups. TEAEs Common Terminology Criteria AE grade >=3 occurred in 25% of APR+SoC pts and 30% of PBO+SoC pts. Serious TEAE rates were 27% (APR+SoC) and 30% (PBO+SoC). Conclusion(s): Although APR+SoC did not improve survival in pts hospitalized with severe COVID-19, APR was well tolerated with a safety profile consistent with the established safety profile.

Air pollution and health prevention: A document of reflection.

Ambient air quality, pollution and its implication on health is a topic of enormous importance that is normally dealt with by major specialists in their particular areas of interest. In general, it is not discussed from multidisciplinary approaches or with a language that can reach everyone. For this reason, the Health Sciences Foundation, from its prevention area, has formulated a series of questions to people with very varied competences in the area of ambient air quality in order to obtain a global panorama of the problem and its elements of measurement and control. The answers have been produced by specialists in each subject and have been subjected to a general discussion that has allowed conclusions to be reached on each point. The subject was divided into three main blocks: external ambient air, internal ambient air, mainly in the workplace, and hospital ambient air and the consequences of its poor control. Along with the definitions of each area and the indicators of good and bad quality, some necessary solutions have been pointed out. We have tried to know the current legislation on this problem and the competences of the different administrations on it. Despite its enormous importance, ambient air quality and health is not usually a topic of frequent presence in the general media and we have asked about the causes of this. Finally, the paper addresses a series of reflections from the perspective of ethics and very particularly in the light of the events that the present pandemic raises. This work aims to provide objective data and opinions that will enable non-specialists in the field to gain a better understanding of this worrying reality.

Lives-economy dichotomy as a link between COVID-19 and the Chilean social uprising

A month after the closure of all non-essential trade in Chile -a measure taken due to the COVID-19 pandemic-, the manager of an important business union affirmed that "we cannot kill all economic activity in order to save lives". The aim of this article is to identify the social relationships that this statement and its approach in digital media maintains and promotes -in the context of a health emergency-, as well as its link with the social uprising that began in October 2019 in Chile. After the contextualization of this uprising, within the framework of the neoliberal model and the high concentration of wealth, the phrase and its replies are problematized from a psychosocial perspective. With a qualitative approach, articles published in the media linked to the statement were analyzed, by discourse analysis tools oriented by pragmatics and conversational analysis. The results suggest that the loss of lives due to COVID-19 affects certain lives, which are not those of the elite represented by this business manager, but those lives that have already been precarious and lost, since before the pandemic. I conclude that these discourses show the inequality associated with the concentration of wealth and its influence on the Chilean political-economic system. This precariousness of life in the COVID-19 context relates to the way of experiencing the neoliberal model daily, a way challenged by the social uprising's demands for dignity.

Digital transformation for the virtual management of Obesity

Introduction: Obesity is a chronic and multi-factorial disease. The model of chronic care must be based on productive interaction between the health care team and the patient. Due to the Covid19 Pandemic we have transformed the face to face support and treatment of the Obesity patient into a virtual model. Digital model can turns the patient into an “active patient” who participates in making decisions about their own health. Objetives: Describe digital transformation for the virtual management of obese and overweight patients. Material-Methods: We have re-engineered the process of diagnosis, care and treatment of the obese patient in order to integrate telemedicine. The clinical programme described in Figure 1 achieves a complete diagnosis of obesity and associated comorbidities and provides the patient with all the necessary tools for dietary modifications, physical exercise and emotional control during one year. The contact with the patient is mainly virtual through the patient's hospital website. Before medical appointments at 0, 6 and 12 months the programme request complementary tests (Bioelectrical impedance, blood test and abdominal ultrasounds) and asks patient to fill in online forms on personal history, cardiovascular risk factors, treatment, family history, weight history, dietary habits, tests of adherence to the Mediterranean diet, RAPA test for physical exercise, Golberg and EDI scales to examine psychological condition, tests of adherence to the Mediterranean diet, Life Quality Questionnaire(IWQOL-Lite) and Epworth sleepiness scale for SHAS screening. The programme has automatic calculators for Nonalcoholic fatty liver disease (NAFLD) screen (NAFLD fibrosis score/FIB4 Index), cardiovascular risk and Frindisk test for Diabetes risk. System automatic requests a home polysomnography if the Epworth score is greater than 8 and also screens for Nonalcoholic fatty liver disease (NAFLD) using NAFLD score, FIB4 index and abdominal ultrasound and requests Fibroscan if necessary. If EDI and Golberg scales are pathological, the system activates online psychological support. When the patient comes to the medical appointment, the doctor has full information to make an accurate diagnosis. After, the patient undergoes a monthly therapeutic educational group programme and fill in the online Weight and Waist Circumference booklet and podometer record monthly. The patient receives individually tailored nutritional recommendations and physical exercise. Managing obesity with learning Empowers the patient. The aim is to train the patient to become autonomous in the management of the disease. Results: The digital clinical pathway has been activated in December 2020. Conclusions:-Telemedicine enables an intensive, immediate and fluid intervention that allows the patient to actively participate in their own health process, fostering the self-efficacy and responsibility so necessary in the management of chronic diseases.-The IT development of the clinical pathway has allowed us to be more efficient in terms of time and resources by automating procedures like screening of SHAS and NAFLD.

Recommendations for the care of newborns suspected or confirmed of infection by sars-cov-2 in Cuba

In this work are presented recommendations on the care of newborns who are children of mothers diagnosed with COVID-19 in Cuba, and are expressed the general guidelines on the organization of the services for patients care, the main aspects related with the care in the birth moment, feeding related aspects, clinical characteristics described in this stage of life, complementary studies that must be conducted for diagnosis, the treatment to be used, and discharge and follow up criteria. The autors collected poor existent scientific evidence on the infection by coronavirus in the neonatal stage, and jointly with the National Group of Neonatology of the Ministry of Public Health are proposing these recommendations which are adapted to the characteristics of the neonatal care in Cuba with the aim of guiding the behaviours to implement in the attention to newborns suspected or with confirmed diagnosis of COVID-19.These recommendations are based in the available scientific publications and they are subject to changes since this is an emerging infection and there is scarse information of its presence in the earliest stages of life like it can be a confirmed case of just 36 hours of life. It is expected that all the personnel involved in the attention of newborns suspected or confirmed with infection by SARS-Cov-2 can analyze and add these recommendations to the care and surveillance of their patients. © 2020, Editorial Ciencias Medicas. All rights reserved.

No transmission of SARS-CoV-2 in a patient undergoing allogeneic hematopoietic cell transplantation from a matched-related donor with unknown COVID-19.

The Hematology Department and its Hematopoietic Cell Transplantation (HCT) program implemented several measures during COVID-19 outbreak in order to keep clinical activities with the maximum security for both donors and recipients. Nevertheless, there was a lack of evidence whether blood products and specifically bone marrow can cause transfusion-transmitted infection. Initially, there were many uncertainties and did not exist formal recommendations. Before official statements were available, we performed an allogeneic HCT in a 57-year-old male from a related matched donor in the incubation period of COVID-19 where the patient did not develop the disease. Actual epidemiology data suggest that transmission may occur early in the course of infection, even from asymptomatic patients in the incubation period. In our knowledge this is the first case report of an adult hematopoietic cell donor with COVID-19 in the incubation period where the transplant is successfully completed with no transmission of SARS-CoV-2. The low concentration of viral RNA in plasma of patients with COVID-19 could support the safety of blood products, including peripheral blood hematopoietic cells. In conclusion, blood products including hematopoietic stem cells are safe in the context of COVID-19 pandemic.