Microbiome in the nasopharynx: Insights into the impact of COVID-19 severity.

Background: The respiratory tract harbors a variety of microbiota, whose composition and abundance depend on specific site factors, interaction with external factors, and disease. The aim of this study was to investigate the relationship between COVID-19 severity and the nasopharyngeal microbiome. Methods: We conducted a prospective cohort study in Mexico City, collecting nasopharyngeal swabs from 30 COVID-19 patients and 14 healthy volunteers. Microbiome profiling was performed using 16S rRNA gene analysis. Taxonomic assignment, classification, diversity analysis, core microbiome analysis, and statistical analysis were conducted using R packages. Results: The microbiome data analysis revealed taxonomic shifts within the nasopharyngeal microbiome in severe COVID-19. Particularly, we observed a significant reduction in the relative abundance of Lawsonella and Cutibacterium genera in critically ill COVID-19 patients (p < 0.001). In contrast, these patients exhibited a marked enrichment of Streptococcus, Actinomyces, Peptostreptococcus, Atopobium, Granulicatella, Mogibacterium, Veillonella, Prevotella_7, Rothia, Gemella, Alloprevotella, and Solobacterium genera (p < 0.01). Analysis of the core microbiome across all samples consistently identified the presence of Staphylococcus, Corynebacterium, and Streptococcus. Conclusions: Our study suggests that the disruption of physicochemical conditions and barriers resulting from inflammatory processes and the intubation procedure in critically ill COVID-19 patients may facilitate the colonization and invasion of the nasopharynx by oral microorganisms.

Evolutionary Echoes: A Four-Day Fasting and Low-Caloric Intake Study on Autonomic Modulation and Physiological Adaptations in Humans.

This study evaluates the psychophysiological response to a simulated hunter-gatherer endurance task with restricted caloric intake over four days. It assesses changes in body composition, autonomic modulation, and physical and cognitive performance. Participants underwent daily 8 h fasted walks followed by a 150 kcal meal to replicate hunter-gatherer activity and dietary patterns. Measurements of metabolic, respiratory, and subjective well-being, along with heart rate variability (HRV) monitoring, were conducted pre- and post-activity to evaluate the impact of endurance activity under caloric restriction. We found weight loss, decreased body and visceral fat, and reduced skeletal muscle mass and water percentage. High sympathetic activation and stable urinary markers, except for increased proteinuria, indicated stress responses and muscular degradation. Elevated perceived exertion post-exercise with good adaptation to prolonged effort underlines the body's adaptability to ancestral lifestyle conditions, highlighting the connection among endurance, nutrition, and psychophysiological health.

Changes in pulmonary mechanics from supine to prone position measured through esophageal manometry in critically ill patients with COVID-19 severe acute respiratory distress syndrome.

OBJECTIVE: To describe changes in pulmonary mechanics when changing from supine position (SP) to prone position (PP) in mechanically ventilated (MV) patients with Acute Respiratory Distress Syndrome (ARDS) due to severe COVID-19. DESIGN: Retrospective cohort. SETTING: Intensive Care Unit of the National Institute of Respiratory Diseases (Mexico City). PATIENTS: COVID-19 patients on MV due to ARDS, with criteria for PP. INTERVENTION: Measurement of pulmonary mechanics in patients on SP to PP, using esophageal manometry. MAIN VARIABLES OF INTEREST: Changes in lung and thoracic wall mechanics in SP and PP RESULTS: Nineteen patients were included. Changes during first prone positioning were reported. Reductions in lung stress (10.6 vs 7.7, p=0.02), lung strain (0.74 vs 0.57, p=0.02), lung elastance (p=0.01), chest wall elastance (p=0.003) and relation of respiratory system elastances (p=0.001) were observed between patients when changing from SP to PP. No differences were observed in driving pressure (p=0.19) and transpulmonary pressure during inspiration (p=0.70). CONCLUSIONS: Changes in pulmonary mechanics were observed when patients were comparing values of supine position with measurements obtained 24h after prone positioning. Esophageal pressure monitoring may facilitate ventilator management despite patient positioning.

The Role of Adipokines in Health and Disease.

Adipokines are cell-signaling proteins secreted by adipose tissue that has been related to a low-grade state of inflammation and different pathologies. The present review aims to analyze the role of adipokines in health and disease in order to understand the important functions and effects of these cytokines. For this aim, the present review delves into the type of adipocytes and the cytokines produced, as well as their functions; the relations of adipokines in inflammation and different diseases such as cardiovascular, atherosclerosis, mental diseases, metabolic disorders, cancer, and eating behaviors; and finally, the role of microbiota, nutrition, and physical activity in adipokines is discussed. This information would allow for a better understanding of these important cytokines and their effects on body organisms.

Feeding intolerance during prolonged prone position in overweight and obese patients with severe COVID-19 / Intolerancia a la alimentación durante el prono prolongado en pacientes con COVID-19 y sobrepeso y obesidad

Objective: the aim of this study was to compare the incidence rate of feeding intolerance (FI) during supine (SP) or prone positioning (PP) in critically ill COVID-19 patients. Methods: this was a retrospective cohort study of critically ill patients with overweight or obesity who received enteral nutrition (EN) in prone or supine positioning continuously during the first five days of mechanical ventilation. Nutritional risk, anthropometric measurements and body composition were assessed at the first 24 hours upon Intensive Care Unit (ICU) admission. Biochemical and clinical variables (Sequential Organ Failure Assessment [SOFA], Acute Physiology and Chronic Health Evaluation II [APACHE II], Acute Kidney Injury [AKI] or comorbidities diagnosis) were collected. Pharmacotherapy (prokinetics, sedatives or neuromuscular blocking agents) and FI incidence (gastric residual volume [GRV] ≥ 200 ml or ≥ 500 ml, vomiting or diarrhea) were daily recorded. Constipation was defined as the absence of evacuation for five consecutive days. Results: eighty-two patients were included. Higher rate of prophylactic prokinetic prescription was observed in PP (42.8 vs 12.5 %, p = 0.002). GRV ≥ 200 in supine position was not different when compared to PP (p = 0.47). Vomiting episodes in supine compared to PP showed no difference between groups (15 % vs 24 %, p = 0.31). No differences in diarrhea events were detected (10 % vs 4.7 %, p = 0.36). Constipation was common in both groups (95 % vs 82 %, p = 0.06). Conclusion: FI during prone position was not different in comparison to supine position. Routinely use of prokinetics in continuous prone position may help to prevent FI incidence. Algorithm development is necessary for FI prevention and treatment so to avoid EN interruptions and adverse clinical outcomes. (AU)

Objetivo: comparar la incidencia de intolerancia a la alimentación entre pacientes críticos en posición supino (PS) o prono (PP). Métodos: cohorte retrospectiva de pacientes bajo ventilación mecánica por distrés respiratorio por COVID-19 y sobrepeso y obesidad, quienes recibieron nutrición enteral (NE) en PP o PS. Se evaluaron riesgo nutricional, mediciones antropométricas y composición corporal en las primeras 24 horas de ingreso a la Unidad de Cuidados Intensivos (UCI). Se recolectaron variables bioquímicas y clínicas (Sequential Organ Failure Assessment [SOFA], Acute Physiology and Chronic Health Evaluation II [APACHE II], lesión renal aguda y otras comorbilidades). Se registró el esquema de farmacoterapia prescrita durante los primeros cinco días (procinéticos, sedantes y bloqueadores neuromusculares). Se evaluó la incidencia de intolerancia a la alimentación, definida como la presencia de residuo gástrico (RG) ≥ 200 o ≥ 500 ml, vómito, diarrea o estreñimiento. Resultados: fueron incluidos 82 pacientes. Se observó una mayor prescripción de procinéticos como terapia profiláctica en PP (42,8 vs. 12,5 %, p = 0,002). No se observaron diferencias en RG ≥ 200 ml (p = 0,47) ni vómito (p = 0,31) entre ambos grupos. No se observaron diferencias en episodios de diarrea (10 % en PS vs. 4,7 % en PP, p = 0,36). El estreñimiento fue común en ambos grupos de estudio (95 vs. 82 %, p = 0,06). Conclusiones: la PP no se relaciona con una mayor incidencia de intolerancias a la alimentación. El uso rutinario de procinéticos durante la PP continua puede ayudar a prevenir la incidencia de dichas intolerancias. Es necesario el desarrollo de algoritmos para la prevención y tratamiento de las intolerancias a la alimentación para evitar interrupciones en la NE y desenlaces no deseables. (AU)

Feeding intolerance during prolonged prone position in overweight and obese patients with severe COVID-19.

Introduction: Objective: the aim of this study was to compare the incidence rate of feeding intolerance (FI) during supine (SP) or prone positioning (PP) in critically ill COVID-19 patients. Methods: this was a retrospective cohort study of critically ill patients with overweight or obesity who received enteral nutrition (EN) in prone or supine positioning continuously during the first five days of mechanical ventilation. Nutritional risk, anthropometric measurements and body composition were assessed at the first 24 hours upon Intensive Care Unit (ICU) admission. Biochemical and clinical variables (Sequential Organ Failure Assessment [SOFA], Acute Physiology and Chronic Health Evaluation II [APACHE II], Acute Kidney Injury [AKI] or comorbidities diagnosis) were collected. Pharmacotherapy (prokinetics, sedatives or neuromuscular blocking agents) and FI incidence (gastric residual volume [GRV] ≥ 200 ml or ≥ 500 ml, vomiting or diarrhea) were daily recorded. Constipation was defined as the absence of evacuation for five consecutive days. Results: eighty-two patients were included. Higher rate of prophylactic prokinetic prescription was observed in PP (42.8 vs 12.5 %, p = 0.002). GRV ≥ 200 in supine position was not different when compared to PP (p = 0.47). Vomiting episodes in supine compared to PP showed no difference between groups (15 % vs 24 %, p = 0.31). No differences in diarrhea events were detected (10 % vs 4.7 %, p = 0.36). Constipation was common in both groups (95 % vs 82 %, p = 0.06). Conclusion: FI during prone position was not different in comparison to supine position. Routinely use of prokinetics in continuous prone position may help to prevent FI incidence. Algorithm development is necessary for FI prevention and treatment so to avoid EN interruptions and adverse clinical outcomes.

Introducción: Objetivo: comparar la incidencia de intolerancia a la alimentación entre pacientes críticos en posición supino (PS) o prono (PP). Métodos: cohorte retrospectiva de pacientes bajo ventilación mecánica por distrés respiratorio por COVID-19 y sobrepeso y obesidad, quienes recibieron nutrición enteral (NE) en PP o PS. Se evaluaron riesgo nutricional, mediciones antropométricas y composición corporal en las primeras 24 horas de ingreso a la Unidad de Cuidados Intensivos (UCI). Se recolectaron variables bioquímicas y clínicas (Sequential Organ Failure Assessment [SOFA], Acute Physiology and Chronic Health Evaluation II [APACHE II], lesión renal aguda y otras comorbilidades). Se registró el esquema de farmacoterapia prescrita durante los primeros cinco días (procinéticos, sedantes y bloqueadores neuromusculares). Se evaluó la incidencia de intolerancia a la alimentación, definida como la presencia de residuo gástrico (RG) ≥ 200 o ≥ 500 ml, vómito, diarrea o estreñimiento. Resultados: fueron incluidos 82 pacientes. Se observó una mayor prescripción de procinéticos como terapia profiláctica en PP (42,8 vs. 12,5 %, p = 0,002). No se observaron diferencias en RG ≥ 200 ml (p = 0,47) ni vómito (p = 0,31) entre ambos grupos. No se observaron diferencias en episodios de diarrea (10 % en PS vs. 4,7 % en PP, p = 0,36). El estreñimiento fue común en ambos grupos de estudio (95 vs. 82 %, p = 0,06). Conclusiones: la PP no se relaciona con una mayor incidencia de intolerancias a la alimentación. El uso rutinario de procinéticos durante la PP continua puede ayudar a prevenir la incidencia de dichas intolerancias. Es necesario el desarrollo de algoritmos para la prevención y tratamiento de las intolerancias a la alimentación para evitar interrupciones en la NE y desenlaces no deseables.

Differential Leukocyte Expression of IFITM1 and IFITM3 in Patients with Severe Pandemic Influenza A(H1N1) and COVID-19.

Interferon-induced transmembrane (IFITM) proteins mediate protection against enveloped viruses by blocking membrane fusion at endosomes. IFITM1 and IFITM3 are crucial for protection against influenza, and various single nucleotide polymorphisms altering their function have been linked to disease susceptibility. However, bulk IFITM1 and IFITM3 mRNA expression dynamics and their correlation with clinical outcomes have not been extensively addressed in patients with respiratory infections. In this study, we evaluated the expression of IFITM1 and IFITM3 in peripheral leukocytes from healthy controls and individuals with severe pandemic influenza A(H1N1) or coronavirus disease 2019 (COVID-19). Comparisons between participants grouped according to their clinical characteristics, underlying disease, and outcomes showed that the downregulation of IFITM1 was a distinctive characteristic of severe pandemic influenza A(H1N1) that correlated with outcomes, including mortality. Conversely, increased IFITM3 expression was a common feature of severe pandemic influenza A(H1N1) and COVID-19. Using a high-dose murine model of infection, we confirmed not only the downregulation of IFITM1 but also of IFITM3 in the lungs of mice with severe influenza, as opposed to humans. Analyses in the comparative cohort also indicate the possible participation of IFITM3 in COVID-19. Our results add to the evidence supporting a protective function of IFITM proteins against viral respiratory infections in humans.

Labeling of Genetically Modified (GM) Foods in Peru: Current Dogma and Insights of the Regulatory and Legal Statutes.

The COVID-19 pandemic has affected and afflicted human lives and been a transformative catalyst leading to closure of many companies, disrupting mental health, and reducing access to food and exacerbating food insecurity. This presents an opportunity to reflect on and examine genetically modified (GM) foods and their effective legislative regulation for the benefit of consumers. This review presents a detailed analysis of GM foods' regulation in Peru and the analysis of certain specific cases that show the need for greater regulation of the industry.

Mis-Dis Information in COVID-19 Health Crisis: A Narrative Review.

BACKGROUND: In this narrative review, we address the COVID-19 pandemic mis-dis information crisis in which healthcare systems have been pushed to their limits, with collapses occurring worldwide. The context of uncertainty has resulted in skepticism, confusion, and general malaise among the population. Informing the public has been one of the major challenges during this pandemic. Misinformation is defined as false information shared by people who have no intention of misleading others. Disinformation is defined as false information deliberately created and disseminated with malicious intentions. OBJECTIVE: To reach a consensus and critical review about mis-dis information in COVID-19 crisis. METHODS: A database search was conducted in PsychINFO, MedLine (Pubmed), Cochrane (Wiley), Embase and CinAhl. Databases used the MeSH-compliant keywords of COVID-19, 2019-nCoV, Coronavirus 2019, SARS-CoV-2, misinformation, disinformation, information, vaccines, vaccination, origin, target, spread, communication. RESULTS: Both misinformation and disinformation can affect the population's confidence in vaccines (development, safety, and efficacy of vaccines, as well as denial of the severity of SARS-CoV infection). Institutions should take into account that a great part of the success of the intervention to combat a pandemic has a relationship with the power to stop the misinformation and disinformation processes. The response should be well-structured and addressed from different key points: central level and community level, with official and centralized communication channels. The approach should be multifactorial and enhanced by the collaboration of social media companies to stop misleading information, and trustworthy people both working or not working in the health care systems to boost the power of the message. CONCLUSIONS: The response should be well-structured and addressed from different key points: central level and community level, with official and clearly centralized communication channels. The approach should be multifactorial and enhanced from the collaboration of social media companies to stop misleading information, and trustworthy people both working and not working in the health care systems to boost the power of a message based on scientific evidence.

Efectividad de las vacunas contra SARS-CoV-2 en hospitalizados con fallas vacunales en 10 hospitales de la CCINSHAE.

OBJETIVO: Evaluar la efectividad de las vacunas contra SARS-CoV-2 para evitar muerte e intubación en pacientes hospitalizados con Covid-19. Material y métodos. Se presentó un análisis de 3 565 hospitalizaciones por SARS-CoV-2 de personas mayores de 20 años de edad, reportadas con fines de salud pública por 10 hospitales de especialidad. Se comparó a los egresados por mejoría (2 094) con los fallecidos (1 471) en modelos mixtos de regresión logística ajustados por edad, sexo, número de comorbilidades y el hospital como variable aleatoria. RESULTADOS: Un esquema completo de vacunación, con cinco tipos de vacunas disponi-bles, tuvo un efecto protector para muerte o intubación (RM: 0.67, IC95%: 0.54,0.83, 33% de protección); y para muerte (RM: 0.80, IC95%: 0.64,0.99, 20% de protección) estos datos se compararon con los que no habían sido vacunados. Todas las vacunas aplicadas mostraron un efecto protector con un RM<0.8, con intervalos de confianza variables. Conclusio-nes. El antecedente de vacunación reduce los riesgos de ser intubado y morir, aun en pacientes previamente vacunados y hospitalizados con Covid-19 grave.

Efectividad de las vacunas contra SARS-CoV-2 en hospitalizados con fallas vacunales en 10 hospitales de la CCINSHAE / Effectiveness of SARS-CoV-2 vaccines in hospitalized patients with vaccine failures in 10 CCINSHAE hospitals

Resumen: Objetivo: Evaluar la efectividad de las vacunas contra SARS-CoV-2 para evitar muerte e intubación en pacientes hospitalizados con Covid-19. Material y métodos: Se presentó un análisis de 3 565 hospitalizaciones por SARS-CoV-2 de personas mayores de 20 años de edad, reportadas con fines de salud pública por 10 hospitales de especialidad. Se comparó a los egresados por mejoría (2 094) con los fallecidos (1 471) en modelos mixtos de regresión logística ajustados por edad, sexo, número de comorbilidades y el hospital como variable aleatoria. Resultados: Un esquema completo de vacunación, con cinco tipos de vacunas disponibles, tuvo un efecto protector para muerte o intubación (RM: 0.67, IC95%: 0.54,0.83, 33% de protección); y para muerte (RM: 0.80, IC95%: 0.64,0.99, 20% de protección) estos datos se compararon con los que no habían sido vacunados. Todas las vacunas aplicadas mostraron un efecto protector con un RM<0.8, con intervalos de confianza variables. Conclusiones: El antecedente de vacunación reduce los riesgos de ser intubado y morir, aun en pacientes previamente vacunados y hospitalizados con Covid-19 grave.

Abstract: Objective: To evaluate the effectiveness of SARS-CoV-2 vaccines to avoid death and intubation in hospitalized patients with Covid-19. Materials and methods: We present an analysis of 3 565 hospitalizations for SARS-CoV-2 in people over 20 years of age, reported for public health purposes by 10 specialty hospitals, comparing those discharged for improvement (2 094) with those who died (1 471) in mixed models of logistic regression adjusted for age, sex, number of comorbidities and the reporting hospital as a random variable. Results: A complete vaccination schedule, with five types of vaccine available, had a protective effect for death or intubation (OR: 0.67, CI95%: 0.54,0.83, 33% protection) and for death (OR: 0.80, CI95%: 0.64,0.99, 20% protection) compared to those who had not been vaccinated. All the applied vaccines in the Mexican program showed a protective effect with an OR<0.8, with variable confidence intervals. Conclusions: Even in patients previously vaccinated and hospitalized with severe Covid-19, a history of vaccination reduces the risks of being intubated and dying.

Phase angle and overhydration are associated with post-extubating dysphagia in patients with COVID-19 discharged from the ICU.

BACKGROUND: Few studies have evaluated the prevalence of post-extubation dysphagia and associated factors in patients with coronavirus disease 2019 (COVID-19) . Our study assessed the prevalence of post-extubation dysphagia and body composition in patients with COVID-19 discharged from an intensive care unit (ICU). METHODS: A prospective cohort study was performed in post-ICU extubated patients with acute respiratory distress syndrome related to COVID-19 in two referral hospitals. A total of 112 patients were evaluated and included; swallowing assessment and bioelectrical impedance analysis (BIA) were performed after extubation and discharge from the ICU. To identify associations between dysphagia, lower phase angle (PhA) (<4.8°) and hydration (extracellular water/total body water < 0.390) logistic and linear regression analyses were conducted. RESULTS: The incidence of post-extubation dysphagia was 41% (n = 46). From these, 65% (n = 30) had severe swallowing impairment. Overhydration and PhA were significantly different in patients with dysphagia, and segmental hydration in the trunk and legs was higher than in arms. PhA <4.8° (odds ratio [OR], 12.2; 95% CI, 4.3-34.1; P < .05) and overhydration measured by BIA (OR, 9.1; 95% CI, 3.4-24.5; P < .05) were associated with post-extubation dysphagia in multivariate analysis. PhA (<4.8°) was associated with a lower rate of swallowing recovery at hospital discharge (log-rank test = 0.007). CONCLUSIONS: A high incidence of post-extubation dysphagia was found in patients with COVID-19. Low PhA and overhydration were associated with the presence of dysphagia. Lower PhA was an independent factor for swallowing recovery at discharge.

Low phase angle is associated with 60-day mortality in critically ill patients with COVID-19.

BACKGROUND: Malnutrition status, body composition indicators, and bioelectrical impedance analysis (BIA) parameters have been associated with increased risk of death in several pathologies. The aim of this study was to describe the associations between phase angle (PhA) indicators obtained by BIA with length of hospital stay, days on mechanical ventilation, and 60-day mortality in critically ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: This is a prospective cohort of mechanically ventilated patients with coronavirus disease 2019 (COVID-19). We assessed nutrition risk and body composition with BIA within 48 h from intensive care unit admission. Logistic and linear regression models were used to analyze the association between variables and clinical outcomes. Survival analysis by PhA value was performed using Kaplan-Meier curves. RESULTS: Sixty-seven patients were included. PhA (odds ratio [OR], 0.36; P = .002), standardized PhA (SPA) (OR, 0.45; P = .001), and extracellular water/total body water ratio (OR, 3.25; P = .002) were significant predictors of 60-day mortality. PhA <3.85° in females and <5.25° in males showed good and fair discrimination, respectively, for mortality prediction. Using cutoff values, low PhA was associated with a significantly increased risk of 60-day mortality (hazard ratio, 3.08; 95% CI, 1.12-8.41; P = .02). No association was detected for SPA. CONCLUSION: Low PhA values could be a predictor of 60-day mortality in critically ill patients with COVID-19. This biological marker could be incorporated as part of nutrition and mortality risk assessment in this population.

¿Cómo lograr la excelencia sanitaria en la atención del paciente con enfermedad renal crónica? Desarrollo de vías clínicas para los estadios iniciales de la enfermedad

Las vías clínicas (VC) son instrumentos desarrollados para planificar y coordinar la secuencia de los procedimientos clínicos y administrativos necesarios para conseguir la máxima calidad asistencial. La rápida difusión de las VC en Estados Unidos explica que más del 60% de los hospitales usen estos documentos para sus procesos más frecuentes, lo que contrasta con su escasa implementación en Colombia y países de Latinoamérica. Las VC se ajustan según los cambios que representa el enfoque en procesos y se orientan a optimizar una mejor atención al paciente.

The clinical pathways are instruments developed to plan and coordinate the sequence of clinical and administrative procedures necessary to achieve the highest quality of care. Its rapid spread in the USA. USA explains that more than 60% of hospitals use clinical pathways for their most frequent processes. This contrasts with its poor implementation in Colombia and the countries of the Region of the Americas. The Clinical Pathways adjust with the change represented by the focus on processes, aimed at optimizing better patient care.

The Impact of the COVID-19 Pandemic on Mental Disorders. A Critical Review.

The COVID-19 pandemic has impacted the lives of the worldwide population. Citizens suffer the social, economic, physiological, and psychological effects of this pandemic. Primary sources, scientific articles, and secondary bibliographic indexes, databases, and web pages were used for a consensus critical review. The method was a narrative review of the available literature to summarize the existing literature addressing mental health concerns and stressors related to the COVID-19 pandemic. The main search engines used in the present research were PubMed, SciELO, and Google Scholar. We found the pandemic has had a direct impact on psychopathologies such as anxiety, increasing its ratios, and depression. Other syndromes such as burnout and post-traumatic stress disorder have increased with the pandemic, showing a larger incidence among medical personnel. Moreover, eating disorders and violence have also increased. Public authorities must prepare healthcare systems for increasing incidences of mental pathologies. Mental health apps are one of the tools that can be used to reach the general population.

Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial.

INTRODUCTION: The novel coronavirus pandemic (COVID-19) represents a major public health problem and it is key to find a treatment that reduces mortality. Our objective was to estimate whether treatment with 400 mg/day of Hydroxychloroquine for 10 days reduces in-hospital mortality in subjects with severe respiratory disease due to COVID-19 compared with placebo. MATERIAL AND METHODS: A double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19 through an intention-to-treat analysis. Eligible for the study were adults aged more than 18 years with COVID-19 confirmed by RT-PCR and lung injury requiring hospitalization with or without mechanical ventilation. Primary outcome was 30-day mortality. Secondary outcomes: days of mechanical ventilation, days of hospitalization and cumulative incidence of serious adverse events. RESULTS: A total of 214 patients with COVID-19 were recruited, randomized and analyzed. They were hypoxemic with a mean SpO2 of 65% ± 20, tachycardic (pulse rate 108±17 min-1) and tachypneic (32 ±10 min-1); 162 were under mechanical ventilation at randomization. Thirty-day mortality was similar in both groups (38% in Hydroxychloroquine vs. 41% in placebo, hazard ratio [HR] 0.88, 95% Confidence Interval [95%CI] 0.51-1.53). In the surviving participants, no significant difference was found in secondary outcomes. CONCLUSION: No beneficial effect or significant harm could be demonstrated in our randomized controlled trial including 214 patients, using relatively low doses of Hydroxychloroquine compared with placebo in hospitalized patients with severe COVID-19.

Clinical Risk Factors for Mortality Among Critically Ill Mexican Patients With COVID-19.

Little literature exists about critically ill patients with coronavirus disease 2019 (COVID-19) from Latin America. Here, we aimed to describe the clinical characteristics and mortality risk factors in mechanically ventilated COVID-19 patients from Mexico. For this purpose, we recruited 67 consecutive mechanically ventilated COVID-19 patients which were grouped according to their clinical outcome (survival vs. death). Clinical risk factors for mortality were identified by machine-learning and logistic regression models. The median age of participants was 42 years and 65% were men. The most common comorbidity observed was obesity (49.2%). Fever was the most frequent symptom of illness (88%), followed by dyspnea (84%). Multilobe ground-glass opacities were observed in 76% of patients by thoracic computed tomography (CT) scan. Fifty-two percent of study participants were ventilated in prone position, and 59% required cardiovascular support with norepinephrine. Furthermore, 49% of participants were coinfected with a second pathogen. Two-thirds of COVID-19 patients developed acute kidney injury (AKIN). The mortality of our cohort was 44.7%. AKIN, uric acid, lactate dehydrogenase (LDH), and a longitudinal increase in the ventilatory ratio were associated with mortality. Baseline PaO2/FiO2 values and a longitudinal recovery of lymphocytes were protective factors against mortality. Our study provides reference data about the clinical phenotype and risk factors for mortality in mechanically ventilated Mexican patients with COVID-19.