https://hdl.handle.net/20.500.12959/4190 Wed, 29 Apr 2026 12:46:19 GMT 2026-04-29T12:46:19Z https://hdl.handle.net/20.500.12959/4194 The Neutrophil-to-Lymphocyte Ratio and the Platelet-to-Lymphocyte Ratio as Predictors of Mortality in Older Adults Hospitalized with COVID-19 in Peru Ortega Rojas, Solangel; Salazar Talla, Leslie; Romero Cerdán, Anthony; Soto Becerra, Percy; Díaz Vélez, Cristian; Urrunaga Pastor, Diego; Maguiña, Jorge L. Background. The prognostic value of the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) in patients with COVID-19 is rarely described in older adults. We aimed to estimate the prognostic value of NLR and PLR, determining the mortality of adults over 60 years of age hospitalized for COVID-19 in three hospitals in Peru from March to May 2020. Methods. We performed a secondary analysis of data from a retrospective cohort carried out in Lambayeque, Peru, from March 18 to May 13, 2020. Older adults hospitalized for COVID-19 were included. The outcome variable was in-hospital mortality by all causes, while the exposure variable was the NLR and PLR (categorized in tertiles and numerically, performing a logarithmic transformation). We included sociodemographic variables, comorbidities, vital functions, laboratory markers, and treatment received during hospital stay. We evaluated the association between NLR and PLR using the hazard ratio (HR) in a Cox regression model. We estimated HR with their respective 95% confidence intervals (95% CI). We estimated cumulative/dynamic time-dependent ROC curves and reported area under the curve ROC (AUC-ROC) for 15-, 30-, and 60-day mortality with their respective simultaneous confidence intervals (confidence bands (CB)). Also, we estimated an optimal cut-off point based on the maximally selected rank statistics. Results. A total of 262 hospitalized older adults were analyzed, 71.8% () of whom were male with a median age of 70 years (interquartile range: 65-78). The mean NLR and PLR were 16.8 (95% CI: 14.9-18.7; SD: 15.5) and 50.3 (95% CI: 44.6-55.9; SD: 46.3), respectively. The mortality rate was 68.7% (95% CI: 62.7-74.3). The adjusted Cox regression analysis showed that the high NLR (; 95% CI: 1.43-3.14) and PLR (; 95% CI: 1.30-2.79) tertiles were associated with a higher risk of mortality. The maximum AUC-ROC values at 60 days of follow-up for NLR and PLR were 0.713 (95%CB: 0.627-0.800) and 0.697 (95%CB: 0.583-0.754), respectively. Conclusions. The NLR and PLR are predictors of higher risk of mortality, and these results suggest that both could be reliable and practical markers for the identification of older adults at high risk of mortality by COVID-19. NLR and PLR have prognostic value, with an AUC greater than 0.5; however, by themselves, they are weak prognostic markers. It is important to carry out future studies incorporating these two markers into preexisting models or designing new ones considering them. Wed, 03 Aug 2022 00:00:00 GMT https://hdl.handle.net/20.500.12959/4194 2022-08-03T00:00:00Z https://hdl.handle.net/20.500.12959/4193 Efficacy and safety of convalescent plasma versus standard care in hospitalized patients with COVID-19 from the Peruvian Social Security Health System: open-label, randomized, controlled clinical trial Villanueva, Cristian; Neyra, Ibeth; Sagastegui, Arturo; Chunga, Ausberto; Oyanguren, Martin; Guillermo-Roman, Martina; Soto Ordoñez, Suly; Maguiña, Jorge L.; Hurtado Roca, Yamilee; Soto Becerra, Percy; Araujo Castillo, Roger V. OBJECTIVES: To assess the efficacy and safety of convalescent plasma plus standard of care (CP + SoC) compared with standard of care (SoC) alone in patients hospitalized for moderate to severe COVID-19 who do not yet require mechanical ventilation. METHODS: Phase 2 randomized, parallel-group, randomized, open-label, controlled, superiority, single-center clinical trial. This clinical trial has been registered in REPEC with the following ID: 013-20. Hospitalized adult patients with moderate to severe COVID-19 were enrolled. The allocation ratio was 1:1 in a variable-size permuted block randomization scheme. The primary outcome was death 28 days after the intervention. Secondary outcomes were mortality at 14 and 56 days, time to death at 56 days, time in the ICU at 28 days, time on a mechanical ventilator at 28 days, frequency of adverse events, and frequency of serious adverse events. RESULTS: A total of 64 participants were enrolled, 32 were assigned to CP + SoC, and 32 to SoC. One participant assigned to CP + SoC withdrew his informed consent before applying the treatment. At day 28, there were no statistically significant differences for the primary outcome between the CP + SoC and SoC groups (relative risk: 2.06; 95%CI 0.73 to 7.11; p = 0.190). No differences were found in the incidences of mortality at 56 days (hazard ratio: 2.21; 95%CI 0.66 to 7.33; p = 0.182), admission to the ICU at 28 days (sub-hazard ratio: 2.06; 95%CI 0.57 to 8.55; p = 0.250), admission to mechanical ventilation at 28 days (sub-hazard ratio: 2.19; 95%CI 0.57 to 8.51; p = 0.260). Estimates for days 14 were similar. No infusion-related adverse events were reported during the study. There were no statistically significant differences in the frequency of any adverse events (odds ratio: 2.74; 95%CI 0.90 to 9.10; p = 0.085) or the frequency of serious adverse events (odds ratio: 3.60; 95%CI 0.75 to 26.1; p = 0.75). CONCLUSIONS: No evidence was found that CP had a significant effect in reducing 28-day mortality. There was also no evidence that the frequency of adverse events was higher in those who received CP + SoC than those who received only SoC.; OBJETIVOS: Evaluar la eficacia y la seguridad del plasma convaleciente más el estándar de atención (CP + SoC) en comparación con el estándar de atención (SoC) solo en pacientes hospitalizados por COVID-19 de moderado a grave que aún no requieren ventilación mecánica. MÉTODOS: Ensayo clínico de fase 2, aleatorizado, de grupos paralelos, aleatorizado, abierto, controlado, de superioridad y unicéntrico. Este ensayo clínico ha sido registrado en REPEC con el siguiente ID: 013-20. Se inscribieron pacientes adultos hospitalizados con COVID-19 de moderado a grave. La relación de asignación fue de 1:1 en un esquema de aleatorización de bloques permutados de tamaño variable. El resultado primario fue la muerte 28 días después de la intervención. Los resultados secundarios fueron la mortalidad a los 14 y 56 días, el tiempo hasta la muerte a los 56 días, el tiempo en la UCI a los 28 días, el tiempo en un ventilador mecánico a los 28 días, la frecuencia de eventos adversos y la frecuencia de eventos adversos graves. RESULTADOS: Se inscribió un total de 64 participantes, 32 fueron asignados a CP + SoC y 32 a SoC. Un participante asignado a CP + SoC retiró su consentimiento informado antes de aplicar el tratamiento. En el día 28, no hubo diferencias estadísticamente significativas para el resultado primario entre los grupos CP + SoC y SoC (riesgo relativo: 2,06; IC del 95 %: 0,73 a 7,11; p = 0,190). No se encontraron diferencias en las incidencias de mortalidad a los 56 días (hazard ratio: 2,21; IC95% 0,66 a 7,33; p = 0,182), ingreso en UCI a los 28 días (subhazard ratio: 2,06; IC95% 0,57 a 8,55; p = 0,250), ingreso a ventilación mecánica a los 28 días (subhazard ratio: 2,19; IC95% 0,57 a 8,51; p = 0,260). Las estimaciones para los días 14 fueron similares. No se informaron eventos adversos relacionados con la infusión durante el estudio. CONCLUSIONES: No se encontró evidencia de que la PC tuviera un efecto significativo en la reducción de la mortalidad a los 28 días. Tampoco hubo evidencia de que la frecuencia de eventos adversos fuera mayor en aquellos que recibieron CP + SoC que aquellos que recibieron solo SoC. Sat, 01 Jan 2022 00:00:00 GMT https://hdl.handle.net/20.500.12959/4193 2022-01-01T00:00:00Z https://hdl.handle.net/20.500.12959/3697 Diagnóstico situacional de los Comités Institucionales de Ética en Investigación de la Seguridad Social en Perú Herrera Añazco, Percy; Urrunaga Pastor, Diego; Soto Ordoñez, Suly; Failoc Rojas, Virgilio E.; Estrada Martínez, Maggie; Muñoz del Carpio Toia, Agueda Introducción: Aunque el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) ha impulsado la conformación de Comités Institucionales de Ética en Investigación (CIEI) en la Seguridad Social de Salud del Perú (EsSalud), pueden existir aspectos perfectibles. Se describen las características de los CIEI de EsSalud y sus miembros durante el 2021. Material y Métodos: Se realizó un estudio descriptivo y observacional que empleó una base de datos secundaria. Se encuestó a los miembros de los CIEI de EsSalud mediante un formulario virtual confeccionado por IETSI. Resultados: Se incluyó a 114 miembros pertenecientes a 18 redes prestacionales de EsSalud. El 52,6% de los participantes era de sexo masculino, la media de edad fue de 50,6 ± 11,9 años y el 42,1% tenía función científica. El 38,8% de los CIEI evaluó más de cinco ensayos clínicos en los últimos dos años y el 72,2% más de cinco estudios observacionales en el mismo periodo de tiempo. Los miembros refirieron limitaciones para la realización de reuniones o supervisiones virtuales, falta de tiempo para la realización de sus labores debido a la alta carga laboral y necesidad de capacitaciones sobre metodología de la investigación y bioestadística. Conclusión: Es necesario mejorar el soporte administrativo y el plan de capacitaciones a los miembros de los CIEI de EsSalud, para el logro de competencias metodológicas, éticas y regulatorias que aseguren una mejora en los procesos de evaluación y monitoreo ético de las investigaciones con seres humanos a su cargo.; en Salud (IETSI) has promoted the formation of Institutional Research Ethics Committees (IRECs) in the social security of Peru (EsSalud), there may be perfectible aspects. The characteristics of the IREC of EsSalud and its members during 2021 are described. Material and Methods: A descriptive and observational study was carried out using a secondary database. IREC members were surveyed using a virtual form created by IETSI. 114 members belonging to 18 EsSalud networks were included. Results: 52.6% of the participants were male, the mean age was 50.6 ± 11.9 years, and 42.1% had a scientific role. In 38.8% of the IREC were evaluated more than five clinical trials in the last two years and 72.2% more than five observational studies in the same period. The members reported limitations for holding virtual meetings or supervisions, lack of time to carry out their tasks due to the high workload and the need for training on research methodology and biostatistics. Conclusion: it is necessary to improve the administrative support and the training plan for the members of the IREC of EsSalud, to achieve methodological, ethical, and regulatory competencies that ensure an improvement in the processes of evaluation and ethical monitoring of human research. Thu, 31 Mar 2022 00:00:00 GMT https://hdl.handle.net/20.500.12959/3697 2022-03-31T00:00:00Z https://hdl.handle.net/20.500.12959/3326 Características de los ensayos clínicos activos desarrollados en la Seguridad Social de Salud del Perú Soto Ordoñez, Suly; Herrera Añazco, Percy; Estrada Martínez, Maggie; Failoc Rojas, Virgilio E. Objetivo: Describir las características de los ensayos clínicos activos (EC) desarrollados en la Seguridad Social de Salud del Perú. Material y métodos: Estudio observacional y descriptivo de los EC activos entre el 24 mayo al 8 julio del 2021, inscritos en el Registro Peruano de Ensayos Clínicos durante el periodo 2007-2020. Se analizó la distribución de las diferentes variables tales como N° de EC, fase, redes de EsSalud, regiones en el Perú, patrocinador, fuentes de financiamiento, especialidad, número de centros de investigación (CI) de EsSalud por EC, CIEI que aprobó los ECs por CI, y el cálculo de frecuencias relativas y absolutas. Resultados: Se identificaron 97 EC, ejecutados 144 veces en 23 diferentes CI pertenecientes a EsSalud. El 94,9% de los EC activos fue patrocinado por la industria farmacéutica y el 36% pertenecen a la especialidad de oncología. El 80,42% son de fase III y el 70,8% fue aprobado por un CIEI de EsSalud. Conclusiones: Los EC activos en EsSalud se desarrollan mayormente en Lima, son financiados por la industria farmacéutica y se aprobaron en su mayoría en los CIEIs de EsSalud.; Objetive: To describe the characteristics of active clinical trials (CTs) developed in the Social Health Security of Peru. Material and methods: Observational and descriptive study of active CTs between May 24 to July 8, 2021, registered in the Peruvian Registry of Clinical Trials during the period 2007-2020. The distribution of the different variable was analyzed, such as the number of CTs, phase, EsSalud networks, sponsor, funding sources, specialty, number of EsSalud research centers per CT, CIEI that approved CT by research center, and the calculation of relative and absolute frequencies. 97 Results: active CTs were identified, executed 144 times in 23 different research centers thatbelong to EsSalud. 94.9% of the active CTs were sponsored by pharmaceutical industries and 36% belong to the specialty of oncology. 80.42% are phase III and 70.8% were approved by an EsSalud CIEI. The Conclusions: active CTs in EsSalud are developed mostly in Lima, are financed by the pharmaceutical industry and are mostly approved in the CIEI of EsSalud. Thu, 30 Jun 2022 00:00:00 GMT https://hdl.handle.net/20.500.12959/3326 2022-06-30T00:00:00Z