Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study.

BACKGROUND: Convalescent plasma (CP) has been widely used to treat COVID-19 and is under study. However, the variability in the current clinical trials has averted its wide use in the current pandemic. We aimed to evaluate the safety and efficacy of CP in severe coronavirus disease 2019 (COVID-19) in the early stages of the disease. METHODS: A randomized controlled clinical study was conducted on 101 patients admitted to the hospital with confirmed severe COVID-19. Most participants had less than 14 days from symptoms onset and less than seven days from hospitalization. Fifty patients were assigned to receive CP plus standard therapy (ST), and 51 were assigned to receive ST alone. Participants in the CP arm received two doses of 250 mL each, transfused 24 h apart. All transfused plasma was obtained from "super donors" that fulfilled the following criteria: titers of anti-SARS-CoV-2 S1 IgG ≥ 1:3200 and IgA ≥ 1:800 antibodies. The effect of transfused anti-IFN antibodies and the SARS-CoV-2 variants at the entry of the study on the overall CP efficacy was evaluated. The primary outcomes were the reduction in viral load and the increase in IgG and IgA antibodies at 28 days of follow-up. The per-protocol analysis included 91 patients. RESULTS: An early but transient increase in IgG anti-S1-SARS-CoV-2 antibody levels at day 4 post-transfusion was observed (Estimated difference [ED], - 1.36; 95% CI, - 2.33 to - 0.39; P = 0.04). However, CP was not associated with viral load reduction in any of the points evaluated. Analysis of secondary outcomes revealed that those patients in the CP arm disclosed a shorter time to discharge (ED adjusted for mortality, 3.1 days; 95% CI, 0.20 to 5.94; P = 0.0361) or a reduction of 2 points on the WHO scale when compared with the ST group (HR adjusted for mortality, 1.6; 95% CI, 1.03 to 2.5; P = 0.0376). There were no benefits from CP on the rates of intensive care unit admission (HR, 0.82; 95% CI, 0.35 to 1.9; P = 0.6399), mechanical ventilation (HR, 0.66; 95% CI, 0.25 to 1.7; P = 0.4039), or mortality (HR, 3.2; 95% CI, 0.64 to 16; P = 0.1584). Anti-IFN antibodies and SARS-CoV-2 variants did not influence these results. CONCLUSION: CP was not associated with viral load reduction, despite the early increase in IgG anti-SARS-CoV-2 antibodies. However, CP is safe and could be a therapeutic option to reduce the hospital length of stay. Trial registration NCT04332835.

Mutation profile of SARS-CoV-2 genome in a sample from the first year of the pandemic in Colombia.

The severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is the etiopathogenic agent of COVID-19, a condition that has led to a formally recognized pandemic by March 2020 (World Health Organization -WHO). The SARS-CoV-2 genome is constituted of 29,903 base pairs, that code for four structural proteins (N, M, S, and E) and more than 20 non-structural proteins. Mutations in any of these regions, especially in those that encode for the structural proteins, have allowed the identification of diverse lineages around the world, some of them named as Variants of Concern (VOC) and Variants of Interest (VOI), according to the WHO and CDC. In this study, by using Next Generation Sequencing (NGS) technology, we sequenced the SARS-CoV-2 genome of 422 samples from Colombian residents, all of them collected between April 2020 and January 2021. We obtained genetic information from 386 samples, leading us to the identification of 14 new lineages circulating in Colombia, 13 of which were identified for the first time in South America. GH was the predominant GISAID clade in our sample. Most mutations were either missense (53.6%) or synonymous mutations (37.4%), and most genetic changes were located in the ORF1ab gene (63.9%), followed by the S gene (12.9%). In the latter, we identified mutations E484K, L18F, and D614G. Recent evidence suggests that these mutations concede important particularities to the virus, compromising host immunity, the diagnostic test performance, and the effectiveness of some vaccines. Some important lineages containing these mutations are the Alpha, Beta, and Gamma (WHO Label). Further genomic surveillance is important for the understanding of emerging genomic variants and their correlation with disease severity.

Validación del BESTest en población de adultos mayores colombianos / Validation of the BESTestest in a population of older Colombian adults

Introducción. El envejecimiento y las comorbilidades afectan la cognición y el sistema sensoriomotor de las personas. La pérdida de equilibrio es una de las principales causas de caídas en adultos mayores, por lo que monitorear su desempeño funcional es importante. El sistema de evaluación de equilibrio identifica factores de riesgo para caídas. Objetivos. Identificar las propiedades psicométricas de validez y confiabilidad entre evaluadores y estimar el valor de corte óptimo del BESTest para así diferenciar entre adultos que tienen o no riesgo de caídas. Métodos. Estudio observacional de validez y confiabilidad en el que participaron 221 adultos de entre 50 y 80 años capaces de caminar, con o sin dispositivo de asistencia, de forma independiente durante seis metros y de realizar tareas de equilibrio sin fatiga. Se indagaron datos sociodemográficos, clínicos e historial de caídas. Resultados. Se encontró una correlación significativa entre el sistema de equilibrio con la escala de confianza en las actividades cotidianas (r=0,47, p<0,01), una consistencia interna adecuada para la prueba en general (alfa de Cronbach de 0,90), una sensibilidad del 78% y una especificidad del 66%. El área bajo la curva fue de 0,76, con una discriminación aceptable, es decir, se estableció que las personas que obtienen un puntaje <80 en la prueba tienen alto riesgo de caídas. Conclusiones. El sistema de equilibrio cuenta con buenas propiedades psicométricas que permiten su aplicación confiable en población colombiana. La prueba aporta a la toma de decisiones clínicas gracias a que discrimina el riesgo de caída y el perfil funcional del adulto.

Introduction. Aging and comorbidities affect cognition and the sensorimotor system of individuals. Loss of balance is one of the main causes of falls in older adults, so monitoring their functional performance is important. The balance assessment system identifies risk factors for falls. Objectives. To identify the psychometric properties of validity and inter-rater reliability and to estimate the optimal cut-off value of the BESTest in order to differentiate between adults who are or are not at risk for falls. Methods. Observational validity and reliability study involving 221 adults aged 50 to 80 years able to walk, with or without an assistive device, independently for six meters and to perform balance tasks without fatigue. Sociodemographic and clinical data and history of falls were investigated. Results. We found a significant correlation between the balance system with the confidence in activities of daily living scale (r=0.47, p<0.01), adequate internal consistency for the test overall (Cronbach's alpha of 0.90), sensitivity of 78% and specificity of 66%. The area under the curve was 0.76, with acceptable discrimination, i.e., it was established that persons scoring <80 on the test are at high risk of falls. Conclusions. The balance system has good psychometric properties that allow its reliable application in the Colombian population. The test contributes to clinical decision making because it discriminates the risk of falling and the functional profile of the adult.

Recommendations for providing nutritional care to COVID-19 inpatients. A literature review / Recomendaciones para la atención nutricional hospitalaria en pacientes con COVID-19. Revisión de la literatura

Resumen Introducción. La enfermedad por coronavirus 2019 (COVID-19) puede llevar a la hospitalización de los pacientes en los casos más graves; por tanto, es necesario establecer recomendaciones teórico-prácticas de intervención nutricional hospitalaria. Objetivo. Identificar las recomendaciones dirigidas a los equipos de salud hospitalarios para brindar atención nutricional a pacientes hospitalizados mayores de 18 años e infectados con COVID-19. Materiales y métodos. Se realizó una revisión de la literatura en PubMed mediante la siguiente estrategia de búsqueda: periodo de publicación: diciembre 1 de 2019 a marzo 21 de 2020; idiomas de publicación: inglés y chino; términos de búsqueda: "Coronavirus Infection", "Severe Acute Respiratory Syndrome" y "Nutrition for Vulnerable Groups". Resultados. Se identificaron 283 artículos en la búsqueda inicial, de los cuales se seleccionaron 6 para analizar las prácticas de atención nutricional hospitalaria. Las áreas de investigación de estas publicaciones fueron soporte nutricional; evaluación de intervenciones para abordar y disminuir la severidad de las complicaciones pulmonares y hepáticas, y efectos de antioxidantes y ácidos grasos omega-3 en adultos con síndrome de dificultad respiratoria aguda. Conclusión. Las recomendaciones para la atención nutricional hospitalaria en pacientes con COVID-19 se basan en procesos de cuidado nutricional y en la gestión de los servicios de alimentación; según estas recomendaciones, se deben establecer estrategias de evaluación de riesgo nutricional, realizar intervenciones de soporte nutricional que reduzcan el riesgo de desnutrición y vigilar los riesgos asociados a la administración del soporte nutricional y las alteraciones metabólicas asociadas a esta enfermedad.

Abstract Introduction: Coronavirus disease (COVID-19) may require the hospitalization of patients in the most severe cases. Therefore, it is necessary to establish theoretical and practical recommendations for nutritional interventions at hospitals. Objective: To identify recommendations given to hospital health care teams for providing nutritional care to inpatients over 18 years of age infected with COVID-19. Materials and methods: A literature review was conducted in PubMed using the following search strategy: publication period: December 2019 to March 2020; publication language: English and Chinese; search terms: "Coronavirus Infection", "Severe Acute Respiratory Syndrome" and "Nutrition for Vulnerable Groups". Results: A total of 283 articles were retrieved after completing the initial search, of which 6 were selected to analyze nutrition care practices in the hospital setting. The areas of research of these publications were nutritional support, the evaluation of interventions aimed to manage and reduce the severity of pulmonary and hepatic complications, and the effects of antioxidants and omega-3 fatty acids in adults with acute respiratory distress syndrome. Conclusion: Recommendations for providing nutritional care to COVID-19 inpatients are based on nutritional care processes and food service management. According to these recommendations, nutritional risk assessment strategies should be established, nutritional support interventions aimed at reducing the risk of malnutrition should be carried out, and the risks associated with the administration of nutritional support, as well as COVID-19-re-lated metabolic disorders, should be monitored.

COVID-19 convalescent plasma composition and immunological effects in severe patients.

Convalescent plasma (CP) has emerged as a treatment for COVID-19. However, the composition and mechanism of action are not fully known. Therefore, we undertook a two-phase controlled study in which, first the immunological and metabolomic status of recovered and severe patients were evaluated. Secondly, the 28-day effect of CP on the immune response in severe patients was assessed. Nineteen recovered COVID-19 patients, 18 hospitalized patients with severe disease, and 16 pre-pandemic controls were included. Patients with severe disease were treated with CP transfusion and standard therapy (i.e., plasma recipients, n = 9) or standard therapy alone (n = 9). Clinical and biological assessments were done on day 0 and during follow-up on days 4, 7, 14, and 28. Clinical parameters, viral load, total immunoglobulin (Ig) G and IgA anti-S1-SARS-CoV-2 antibodies, neutralizing antibodies (NAbs), autoantibodies, cytokines, T and B cells, and metabolomic and lipidomic profiles were examined. Total IgG and IgA anti-S1-SARS-CoV-2 antibodies were key factors for CP selection and correlated with NAbs. In severe COVID-19 patients, mostly interleukin (IL)-6 (P = <0.0001), IL-10 (P = <0.0001), IP-10 (P = <0.0001), fatty acyls and glycerophospholipids were higher than in recovered patients. Latent autoimmunity and anti-IFN-α antibodies were observed in both recovered and severe patients. COVID-19 CP induced an early but transient cytokine profile modification and increases IgG anti-S1-SARS-CoV-2 antibodies. At day 28 post-transfusion, a decrease in activated, effector and effector memory CD4+ (P < 0.05) and activated and effector CD8+ (P < 0.01) T cells and naïve B cells (P = 0.001), and an increase in non-classical memory B cells (P=<0.0001) and central memory CD4+ T cells (P = 0.0252) were observed. Moreover, IL-6/IFN-γ (P = 0.0089) and IL-6/IL-10 (P = 0.0180) ratios decreased in plasma recipients compared to those who received standard therapy alone. These results may have therapeutic implications and justify further post-COVID-19 studies.

Evaluación de la Saturación Venosa de Oxígeno (SvO2) desde la teoría de los sistemas dinámicos / Evaluation of SvO2 from the Theory of Dynamic Systems

Introducción: La evolución de un sistema dinámico se puede caracterizar a partir de la construcción de atractores caóticos. Objetivo: Desarrollar una metodología de evaluación de la saturación venosa de oxígeno, fundamentada en los sistemas dinámicos, para pacientes en Unidad de Cuidados Intensivos. Metodología: Se seleccionaron 10 pacientes con diferentes patologías de la Unidad de Cuidados Intensivos Postquirúrgicos, y registró la saturación venosa de oxígeno durante su tiempo de estancia. Con base en estos valores se construyeron atractores caóticos en el mapa de retardo y se evaluaron los valores mínimos y máximos ocupados por el atractor. Resultados: Se halló que la saturación venosa de oxígeno tiene un comportamiento caótico; los valores máximos y mínimos de los atractores en el mapa de retardo variaron entre 22,10 mmHg y 93,70 mmHg. Conclusiones: Se plantea una nueva metodología capaz de caracterizar el comportamiento de la variable monitorizada para la evaluación del paciente crítico(AU)

Introduction: The evolution of a dynamic system can be characterized from the construction of chaotic attractors. Objective: To develop a methodology based on dynamic systems, for the evaluation of venous oxygen saturation of patients in the Intensive Care Unit. Methodology: 10 patients with different pathologies of the Post-surgical Intensive Care Unit were selected, and recorded venous oxygen saturation during their time of stay. Based on these values, chaotic attractors were constructed on the delay map and the minimum and maximum values occupied by the attractor were evaluated. Results: It was found that venous oxygen saturation has a chaotic behavior; the maximum and minimum values of the attractors on the delay map varied between 22.10 mmHg and 93.70 mmHg. Conclusions: A new methodology is proposed capable of characterizing the behavior of this monitored variable for the evaluation of the critical patient(AU)

Meningoencefalitis por Nocardia spp: Reporte de un caso y revisión de la literatura / Nocardia spp meningoencephalitis: A case report and literature review

Resumen La nocardiosis es una rara infección oportunista que afecta principalmente a pacientes con alteración de la inmunidad celular, como pacientes con síndrome de inmunodeficiencia adquirida o postrasplantes. El compromiso del sistema nervioso central es generalmente como absceso y menos frecuentemente como meningitis primaria. El presente artículo hace el reporte de un caso de meningitis primaria por Nocardia en paciente inmunocompetente y revisión de la literatura.

Nocardiosis is a rare opportunistic disease that affects mainly patients with deficient cell-mediated immunity, such as those with acquired immunodeficiency syndrome (AIDS) or transplant recipients. The central nervous system presentation is as cerebral abscesses and less frequently, as primary meningitis. Here, a case of primary nocardia meningitis is described in a patient without a predisposing condition, along with a literature review.