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.

Clinical and sociodemographic factors associated with lupus nephritis in Colombian patients: A cross-sectional study / Factores clínicos y sociodemográficos asociados a nefritis lúpica en pacientes colombianos: resultados de un estudio transversal

Introduction: Over the past decades, incidence of SLE (Systemic Lupus Erythematosus) has increased due to early case detection and improved survival of patients. SLE presents at an earlier age and has a more severe presentation in African-American, Native American, Asian, and Hispanic populations. Worldwide, lupus nephritis (LN) is observed in 29–60% of SLE patients, it has a negative impact in renal survival and patient mortality. Several cohorts have established potential risk factors associated with lupus nephritis, such as male sex, serological markers, and some extra-renal manifestations. Objectives: To describe sociodemographic, clinical, immunological, and environmental risk factors in Colombian SLE patients and to compare the population with and without nephritis, in order to establish risk factors and possible associations. Materials and methods: A total of 1175 SLE patients participated in this study. During medical care, an interview and structured survey was conducted and later registered in a database. Sociodemographic, clinical, immunological, and environmental exposure variables were analyzed. Bivariate and multivariate analyses were performed using presence of LN as an outcome. Results: Prevalence of LN was 38.7%. Variables significantly associated with LN included being male (OR 1.98), a duration of SLE>10 years (OR 1.48), positive anti-DNA (OR 1.34), positive anti-Sm (OR 1.45), and smoking (OR 1.66). Being non-smoker was a protective factor (OR 0.52). Conclusion: This study describes potential factors associated with lupus nephritis in a Latin American population. Smoking status could be a target for intervention as it is a modifiable risk factor. The association between being male and LN is observed in Latin-American populations such as presented here. Further research in other large-scale population studies and more efforts are needed to gain better insights to explicate these relationships.(AU)

Introducción: En las últimas décadas la incidencia del Lupus eritematoso sistémico (LES) se ha incrementado debido a la detección temprana y su mejoría en la supervivencia. La nefritis lúpica (NL) se observa en el 29% a 60% de los pacientes con LES, teniendo un impacto negativo en la supervivencia renal y la mortalidad. Varias cohortes han establecido factores de riesgo asociados con la NL, como el sexo masculino, marcadores serológicos y algunas manifestaciones extrarrenales. Objetivos: Describir los factores de riesgo sociodemográficos, clínicos, inmunológicos y ambientales en pacientes colombianos con LES y comparar la población con y sin NL para establecer posibles asociaciones. Materiales y métodos: Se incluyeron 1175 pacientes con LES, se analizaron variables sociodemográficas, clínicas, inmunológicas y ambientales, tomadas de bases de datos de registros cínicos. Los análisis bivariados y multivariados se realizaron utilizando la presencia de NL como desenlace. Resultados: La prevalencia de NL fue del 38,7%. Las variables significativamente asociadas con NL incluyeron sexo masculino (OR 1.98), una duración del LES>10 años (OR 1.48), anti-ADN positivo (OR 1.34), anti-Sm positivo (OR 1.45) y tabaquismo (OR 1.66), mientras que la ausencia de exposición al tabaco se comportó como factor protector (OR 0.52). Conclusión: Se describen los factores potenciales asociados con NL en una población latinoamericana. El tabaquismo se presenta como un factor de riesgo susceptible de intervención. El sexo masculino y su asociación con NL ya ha sido reportado en otras poblaciones latinoamericanas. Se requieren investigaciones a gran escala en otras poblaciones para explicar mejor estas asociaciones.(AU)

Clinical and sociodemographic factors associated with lupus nephritis in Colombian patients: A cross-sectional study.

INTRODUCTION: Over the past decades, incidence of SLE (Systemic Lupus Erythematosus) has increased due to early case detection and improved survival of patients. SLE presents at an earlier age and has a more severe presentation in African-American, Native American, Asian, and Hispanic populations. Worldwide, lupus nephritis (LN) is observed in 29-60% of SLE patients, it has a negative impact in renal survival and patient mortality. Several cohorts have established potential risk factors associated with lupus nephritis, such as male sex, serological markers, and some extra-renal manifestations. OBJECTIVES: To describe sociodemographic, clinical, immunological, and environmental risk factors in Colombian SLE patients and to compare the population with and without nephritis, in order to establish risk factors and possible associations. MATERIALS AND METHODS: A total of 1175 SLE patients participated in this study. During medical care, an interview and structured survey was conducted and later registered in a database. Sociodemographic, clinical, immunological, and environmental exposure variables were analyzed. Bivariate and multivariate analyses were performed using presence of LN as an outcome. RESULTS: Prevalence of LN was 38.7%. Variables significantly associated with LN included being male (OR 1.98), a duration of SLE>10 years (OR 1.48), positive anti-DNA (OR 1.34), positive anti-Sm (OR 1.45), and smoking (OR 1.66). Being non-smoker was a protective factor (OR 0.52). CONCLUSION: This study describes potential factors associated with lupus nephritis in a Latin American population. Smoking status could be a target for intervention as it is a modifiable risk factor. The association between being male and LN is observed in Latin-American populations such as presented here. Further research in other large-scale population studies and more efforts are needed to gain better insights to explicate these relationships.

Convalescent plasma in Covid-19: Possible mechanisms of action.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible of the coronavirus disease 2019 (COVID-19) pandemic. Therapeutic options including antimalarials, antivirals, and vaccines are under study. Meanwhile the current pandemic has called attention over old therapeutic tools to treat infectious diseases. Convalescent plasma (CP) constitutes the first option in the current situation, since it has been successfully used in other coronaviruses outbreaks. Herein, we discuss the possible mechanisms of action of CP and their repercussion in COVID-19 pathogenesis, including direct neutralization of the virus, control of an overactive immune system (i.e., cytokine storm, Th1/Th17 ratio, complement activation) and immunomodulation of a hypercoagulable state. All these benefits of CP are expected to be better achieved if used in non-critically hospitalized patients, in the hope of reducing morbidity and mortality.

Factores, clínicos, sociodemográficos, inmunológicos y exposicionales en Lupus Eritematoso Sistémico asociados a Nefritis Lúpica en población colombiana / Factors, clinical, sociodemographic, immunological and expositional in Systemic Lupus Erythematosus associated with lupus nephritis in Colombian population

Introducción: El lupus eritematoso sistémico (LES) es una enfermedad autoinmune caracterizada por compromiso de múltiples órganos, siendo la nefritis lúpica (NL)1 una de las manifestaciones mas graves. Objetivo: Establecer factores asociados a nefritis lúpica en los pacientes con LES. Métodos: Estudio de corte trasversal tomado de una cohorte de 1175 pacientes con LES que cumplieron criterios clasificatorios para ACR 1997 o SLICC 2012, atendidos en una IPS especializada entre 2007 y 2015. Se realizó análisis bivariado de múltiples características entre pacientes con presencia y ausencia de NL a través de chi2 para variables cuantitativas y U de Mann Whitney para variables politómicas o cuantitativas sin distribución normal en búsqueda de asociación estadística.

Manifestaciones clínicas y paraclínicas de la hepatitis autoinmune en 48 pacientes de la ciudad de Medellín, 1980-2004 / Clinical and paraclinical manifestations of autoimmune hepatitis in 48 patients from Medellín, Colombia

Objetivo: describir las características clínicas, bioquímicas, histológicas, sociodemográficas y de tratamiento de los pacientes con hepatitis autoinmune (HAI). Metodología: estudio descriptivo retrospectivo de una serie de casos con 48 pacientes de la ciudad de Medellín con diagnóstico de HAI según los criterios del Grupo Internacional de Hepatitis Autoinmune.Resultados: la edad promedio al momento del diagnóstico fue 34 años, 40 pacientes (83.3 por ciento) eran mujeres. Los hallazgos clínicos más frecuentes fueron fatiga (89.6 por ciento) e ictericia (81.3 por ciento). Las medianas de los hallazgos de laboratorio pretratamiento fueron: AST 626 U/L, ALT 547.5 U/L, bilirrubina total 5.64 mg/dL, bilirrubina directa 3.4 mg/dL. Las medianas de los valores de laboratorio postratamiento fueron: AST 40.5 U/L, ALT 44.4 U/L, bilirrubina total 1.1 mg/dL, bilirrubina directa 0.4 mg/dL (p <0.000). El valor promedio de las gamaglobulinas fue 2.2 g/dL; 81.3 por ciento de los pacientes tuvieron biopsia hepática y de ellos 97.4 por ciento tenían hallazgos compatibles con HAI. Cuarenta pacientes tenían anticuerpos antinucleares positivos. Se hallaron enfermedades autoinmunes concurrentes en 19 pacientes, la más frecuente fue la tiroiditis. El tratamiento más frecuentemente administrado fue prednisona más azatioprina en 56.3 por ciento de los pacientes. Cuarenta y un pacientes (85.4 por ciento) respondieron completamente y 12 (25 por ciento) recayeron.Conclusiones: las características sociodemográficas de este grupo de pacientes no son comparables con las encontradas en otras series. Los hallazgos clínicos, histológicos y bioquímicos son similares a los reportados en la literatura, lo que no se observó con las enfermedades autoinmunes asociadas. La mayoría de los pacientes pertenecen al subtipo 1 de la enfermedad.