Hepatic disorders associated with the use of Ivermectin for SARS-CoV-2 infection in adults: a pharmacovigilance study in VigiBase

Aim: The aim of the present study was to review in VigiBase the reports of serious hepatic disorders associated with the use of ivermectin for COVID-19 in adults. Background: In the face of the global health emergency caused by SARS-CoV-2, ivermectin, among other drugs, has been repurposed in some Latin American countries to treat COVID-19. Studies are needed on the safety of ivermectin for this new indication. VigiBase is the WHO pharmacovigilance database that registers all individual case safety reports (ICSRs) from more than 130 countries. Methods: We extracted the ICSRs of men or women aged ≥ 18 years and dated between 1 January 2020 and 7 March 2021 which included an association with the use of ivermectin. Results: Of 1393 ICSRs associated with ivermectin, 60 (4.3%) were registered as "serious." Ivermectin had been used for COVID-19 in 25 of those cases. Among the latter, 6 experienced hepatic disorders (hepatitis, hepatocellular injury, cholestasis, increased alanine aminotransferase and/or aspartate aminotransferase levels, abnormal liver function tests). Conclusion: The safety of the use of ivermectin should be studied more exhaustively, especially as regards the possibility of hepatic disorders developing when the drug is used for COVID-19.

Practica del canto en modalidad virtual para desarrollar emociones primarias en estudiantes universitarios

Resumen: Actualmente el desarrollo de las emociones primarias a través de un taller de canto para estudiantes universitarios es un tema relevante, donde a causa de la pandemia por el Covid 19 se ha trasformado el proceso de enseñanza - aprendizaje a una modalidad virtual, por consiguiente, genera ciertas dificultades emocionales como desánimo, angustia, depresión, etc. : Currently, the development of primary emotions through a singing workshop for university students is a relevant issue, where, due to the Covid 19 pandemic, the teaching-learning process has been transformed into a virtual modality, therefore, generating certain emotional difficulties such as discouragement, anguish, depression, etc. [...]the objective of this research is to determine the percentage of emotional development of university students before and after the application of the singing workshop. The findings focus on the identification of the emotions that the students bring before and after each workshop session, the active participation of the 8 sessions of singing practice in virtual mode in a creative way, the adaptation that the students made in their houses for the practice of singing and the importance of the musical repertoire that was used. En la actualidad a causa del Covid 19 los docentes nos reinventamos y surgieron diversas formas de enseñanza aprendizaje, sin embargo, poco se conoce de propuestas de un taller de canto en modalidad virtual para ser aplicado en estudiantes universitarios a fin de fortalecer sus emociones primarias en sus diversas familias como la alegría, la felicidad, el amor, el placer, el afecto, la sorpresa y la admiración.

Gut Microbiota Diversity and C-Reactive Protein Are Predictors of Disease Severity in COVID-19 Patients.

The risk factors for coronavirus disease 2019 (COVID-19) severity are still poorly understood. Considering the pivotal role of the gut microbiota on host immune and inflammatory functions, we investigated the association between changes in the gut microbiota composition and the clinical severity of COVID-19. We conducted a multicenter cross-sectional study prospectively enrolling 115 COVID-19 patients categorized according to: (1) the WHO Clinical Progression Scale-mild, 19 (16.5%); moderate, 37 (32.2%); or severe, 59 (51.3%), and (2) the location of recovery from COVID-19-ambulatory, 14 (household isolation, 12.2%); hospitalized in ward, 40 (34.8%); or hospitalized in the intensive care unit, 61 (53.0%). Gut microbiota analysis was performed through 16S rRNA gene sequencing, and the data obtained were further related to the clinical parameters of COVID-19 patients. The risk factors for COVID-19 severity were identified by univariate and multivariable logistic regression models. In comparison to mild COVID-19 patients, the gut microbiota of moderate and severe patients have: (a) lower Firmicutes/Bacteroidetes ratio; (b) higher abundance of Proteobacteria; and (c) lower abundance of beneficial butyrate-producing bacteria such as the genera Roseburia and Lachnospira. Multivariable regression analysis showed that the Shannon diversity index [odds ratio (OR) = 2.85, 95% CI = 1.09-7.41, p = 0.032) and C-reactive protein (OR = 3.45, 95% CI = 1.33-8.91, p = 0.011) are risk factors for severe COVID-19 (a score of 6 or higher in the WHO Clinical Progression Scale). In conclusion, our results demonstrated that hospitalized patients with moderate and severe COVID-19 have microbial signatures of gut dysbiosis; for the first time, the gut microbiota diversity is pointed out as a prognostic biomarker of COVID-19 severity.

The relationship between the severity and mortality of SARS-CoV-2 infection and 25-hydroxyvitamin D concentration - a metaanalysis.

INTRODUCTION: There is increasing scientific interest in the possible association between hypovitaminosis D and the risk of SARS-CoV-2 infection severity and/or mortality. OBJECTIVE: To conduct a metanalysis of the association between 25-hydroxyvitamin D (25(OH)D) concentration and SARS-CoV-2 infection severity or mortality. MATERIAL AND METHODS: We searched PubMed, EMBASE, Google scholar and the Cochrane Database of Systematic Reviews for studies published between December 2019 and December 2020. Effect statistics were pooled using random effects models. The quality of included studies was assessed with the Newcastle-Ottawa Scale (NOS). Targeted outcomes: mortality and severity proportions in COVID-19 patients with 25(OH)D deficiency, defined as serum 25(OH)D < 50 nmol/L. RESULTS: In the 23 studies included (n = 2692), the mean age was 60.8 (SD ± 15.9) years and 53.8% were men. Results suggested that vitamin 25(OH)D deficiency was associated with increased risk of severe SARS-CoV-2 disease (RR 2.00; 95% CI 1.47-2.71, 17 studies) and mortality (RR 2.45; 95% CI 1.24-4.84, 13 studies). Only 7/23 studies reported C-reactive protein values, all of which were > 10 mg/L. Conclusions 25(OH)D deficiency seems associated with increased SARS-CoV-2 infection severity and mortality. However, findings do not imply causality, and randomized controlled trials are required, and new studies should be designed to determine if decreased 25(OH)D is an epiphenomenon or consequence of the inflammatory process associated with severe forms of SARS-CoV-2. Meanwhile, the concentration of 25(OH)D could be considered as a negative acute phase reactant and a poor prognosis in COVID-19 infection.

Description of patients with severe COVID-19 treated in a national referral hospital in Peru. / Caracterización de pacientes con COVID-19 grave atendidos en un hospital de referencia nacional del Perú.

In order to describe manifestations from patients with coronavirus disease 2019 (COVID-19), sociodemographic variables such as, previous medical history, clinical and radiological manifestations, treatments and evolution of patients were evaluated. This took place from March 6th to 25th, 2020, in the "Edgardo Rebagliati Martins" National Hospital in Lima. Seventeen patients were registered: 76% were male, with an average age of 53.5 years (range 25-94); 23.5% had returned from abroad; 41.2% were referred from other health facilities; 41.2% were admitted to mechanical ventilation; 29.4% (5 patients) died. The risk factors detected were: advanced age, arterial hypertension and obesity. The main symptoms detected were: cough, fever and dyspnea. Frequent laboratory findings were: elevated C-reactive protein and lymphopenia. The predominant radiological presentation was bilateral interstitial lung infiltrate. A first experience in the management of patients diagnosed with severe COVID-19 in Peru is reported.

Con el objetivo de describir las manifestaciones de pacientes con enfermedad por coronavirus 2019 (COVID-19), se evaluaron variables sociodemográficas, antecedentes, manifestaciones clínicas y radiológicas, tratamientos y evolución en pacientes que ingresaron por emergencia, del 6 al 25 de marzo de 2020, al Hospital Nacional Edgardo Rebagliati Martins en Lima. Se registraron 17 pacientes: el 76% eran varones, edad promedio de 53,5 años (rango de 25 a 94); el 23,5% había regresado del extranjero; 41,2% referido de otros establecimientos de salud; 41,2% ingresó a ventilación mecánica; falleció el 29,4% (5 pacientes). Los factores de riesgo detectados fueron adulto mayor, tener hipertensión arterial y obesidad; los principales síntomas, tos, fiebre y disnea; los hallazgos de laboratorio frecuentes, proteína C reactiva elevada y linfopenia; la presentación radiológica predominante, el infiltrado pulmonar intersticial bilateral. Se reporta una primera experiencia en el manejo de pacientes con diagnóstico de la COVID-19 grave en el Perú.

Severe pneumonia of torpid evolutión in a young patient with a negative molecular test for a new coronavirus

RESUMEN La enfermedad por coronavirus originada en el año 2019 (COVID-19) se ha diseminado rápidamente en todo el mundo produciendo estragos en el sistema de salud y la sociedad. Se reporta el caso de un varón de 26 años de edad con antecedentes de asma y obesidad, que retornó de EE.UU y acudió a emergencia con síntomas respiratorios, hipoxemia e infiltrado intersticial en la radiografía de tórax, se decide internamiento en sala de aislamiento, la prueba molecular RT-PCR de hisopado nasofaríngeo resultó negativa, por lo que fue traslado a una sala de emergencia común. El manejo inicial fue conservador, sin embargo el paciente evolucionó desfavorablemente requiriendo soporte ventilatorio, pero fallece al quinto día de internamiento. Se recibió un segundo resultado positivo para SARS-CoV-2 al día siguiente de fallecido el paciente, siendo una de las primeras víctimas jóvenes en el Perú. ABSTRACT The coronavirus disease originated in the year 2019 (COVID-19), has spread rapidly throughout the world, wreaking havoc on the health system and society. We report the case of a 26-year-old man with a history of asthma and obesity, who returned from the US and went to the emergency room with respiratory symptoms, hypoxemia and interstitial infiltrate on chest radiography, he was admitted to the isolation room The nasopharyngeal swab RT-PCR molecular test was negative, so he was transferred to a common emergency room. Initial management was conservative, however the patient evolved unfavorably requiring ventilatory support, but died on the fifth day of hospitalization. A second positive result for SARS-CoV-2 was received the day after the patient died, being one of the first young victims in Peru

Neumonía grave de evolución tórpida en paciente joven con prueba molecular negativa para nuevo coronavirus

La enfermedad por coronavirus originada en el año 2019 (COVID-19), se ha diseminado rápidamente en todo el mundo produciendo estragos en el sistema de salud y la sociedad. Se reporta el caso de un varón de 26 años de edad con antecedentes de asma y obesidad, que retornó de EE.UU y acudió a emergencia con síntomas respiratorios, hipoxemia e infiltrado intersticial en la radiografía de tórax, se decide internamiento en sala de aislamiento, la prueba molecular RT-PCR de hisopado nasofaríngeo resultó negativa, por lo que fue traslado a una sala de emergencia común. El manejo inicial fue conservador, sin embargo el paciente evolucionó desfavorablemente requiriendo soporte ventilatorio, pero fallece al quinto día de internamiento. Se recibió un segundo resultado positivo para SARS-CoV-2 al día siguiente de fallecido el paciente, siendo una de las primeras víctimas jóvenes en el Perú. The coronavirus disease originated in the year 2019 (COVID-19), has spread rapidly throughout the world, wreaking havoc on the health system and society. We report the case of a 26-year-old man with a history of asthma and obesity, who returned from the US and went to the emergency room with respiratory symptoms, hypoxemia and interstitial infiltrate on chest radiography, he was admitted to the isolation room The nasopharyngeal swab RT-PCR molecular test was negative, so he was transferred to a common emergency room. Initial management was conservative, however the patient evolved unfavorably requiring ventilatory support, but died on the fifth day of hospitalization. A second positive result for SARS-CoV-2 was received the day after the patient died, being one of the first young victims in Peru.

Neumonía grave de evolución tórpida en paciente joven con prueba molecular negativa para nuevo coronavirus

La enfermedad por coronavirus originada en el año 2019 (COVID-19), se ha diseminado rápidamente en todo el mundo produciendo estragos en el sistema de salud y la sociedad. Se reporta el caso de un varón de 26 años de edad con antecedentes de asma y obesidad, que retornó de EE.UU y acudió a emergencia con síntomas respiratorios, hipoxemia e infiltrado intersticial en la radiografía de tórax, se decide internamiento en sala de aislamiento, la prueba molecular RT-PCR de hisopado nasofaríngeo resultó negativa, por lo que fue traslado a una sala de emergencia común. El manejo inicial fue conservador, sin embargo el paciente evolucionó desfavorablemente requiriendo soporte ventilatorio, pero fallece al quinto día de internamiento. Se recibió un segundo resultado positivo para SARS-CoV-2 al día siguiente de fallecido el paciente, siendo una de las primeras víctimas jóvenes en el Perú. The coronavirus disease originated in the year 2019 (COVID-19), has spread rapidly throughout the world, wreaking havoc on the health system and society. We report the case of a 26-year-old man with a history of asthma and obesity, who returned from the US and went to the emergency room with respiratory symptoms, hypoxemia and interstitial infiltrate on chest radiography, he was admitted to the isolation room The nasopharyngeal swab RT-PCR molecular test was negative, so he was transferred to a common emergency room. Initial management was conservative, however the patient evolved unfavorably requiring ventilatory support, but died on the fifth day of hospitalization. A second positive result for SARS-CoV-2 was received the day after the patient died, being one of the first young victims in Peru.

Description of patients with severe COVID-19 treated in a national referral hospital in Peru

RESUMEN Con el objetivo de describir las manifestaciones de pacientes con enfermedad por coronavirus 2019 (COVID-19), se evaluaron variables sociodemográficas, antecedentes, manifestaciones clínicas y radiológicas, tratamientos y evolución en pacientes que ingresaron por emergencia, del 6 al 25 de marzo de 2020, al Hospital Nacional Edgardo Rebagliati Martins en Lima. Se registraron 17 pacientes: el 76% eran varones, edad promedio de 53,5 años (rango de 25 a 94);el 23,5% había regresado del extranjero;41,2% referido de otros establecimientos de salud;41,2% ingresó a ventilación mecánica;falleció el 29,4% (5 pacientes). Los factores de riesgo detectados fueron adulto mayor, tener hipertensión arterial y obesidad;los principales síntomas, tos, fiebre y disnea;los hallazgos de laboratorio frecuentes, proteína C reactiva elevada y linfopenia;la presentación radiológica predominante, el infiltrado pulmonar intersticial bilateral. Se reporta una primera experiencia en el manejo de pacientes con diagnóstico de la COVID-19 grave en el Perú. ABSTRACT In order to describe manifestations from patients with coronavirus disease 2019 (COVID-19), sociodemographic variables such as, previous medical history, clinical and radiological manifestations, treatments and evolution of patients were evaluated. This took place from March 6th to 25th, 2020, in the "Edgardo Rebagliati Martins"National Hospital in Lima. Seventeen patients were registered: 76% were male, with an average age of 53.5 years (range 25-94);23.5% had returned from abroad;41.2% were referred from other health facilities;41.2% were admitted to mechanical ventilation;29.4% (5 patients) died. The risk factors detected were: advanced age, arterial hypertension and obesity. The main symptoms detected were: cough, fever and dyspnea. Frequent laboratory findings were: elevated C-reactive protein and lymphopenia. The predominant radiological presentation was bilateral interstitial lung infiltrate. A first experience in the management of patients diagnosed with severe COVID-19 in Peru is reported.

Clinical - Epidemiological Characteristics Of Patients Deceased By COVID-19 In A National Hospital In Lima, Peru / Características clínicoepidemiológicas de pacientes fallecidos por COVID-19 en un hospital nacional de Lima, Perú

Introducción: La pandemia debida a enfermedad por coronavirus 2019 (COVID-19) ha producido más de 70 mil muertes en el mundo. Objetivo: Describir las características de pacientes fallecidos por COVID-19 en un hospital terciario. Métodos: Estudio descriptivo realizado en el servicio de emergencia del hospital Rebagliati Lima-Perú, que incluye los pacientes fallecidos con resultado positivo a infección por SARS-CoV-2 mediante PCR-TR hasta el 4 de abril de 2020. Se revisó la historia clínica y registros hospitalarios buscando variables sociodemográficas, antecedentes, manifestaciones clínicas, radiológicas, tratamiento y evolución. Resultados: Se identificaron 14 casos, 78,6% de sexo masculino, edad promedio 73,4 años (rango 26 a 97). Adquirieron la infección en el exterior del país el 21,4% de casos. Se encontró factores de riesgo en 92,9% de pacientes (más frecuentes adulto mayor, hipertensión arterial y obesidad). Los síntomas más frecuentes fueron disnea, fiebre y tos, con tiempo de enfermedad 8 días (+/- 3,0); los signos polipnea y estertores respiratorios. Los hallazgos de laboratorio más frecuentes fueron proteína C reactiva elevada (promedio 22 mg/dL) e hipoxemia. La presentación radiológica predominante fue infiltrado pulmonar intersticial bilateral en vidrio esmerilado. Ingresaron a ventilación mecánica 78,6% (11 de 14 casos); recibió azitromicina 71,4%, hidroxicloroquina 64,3% y antibióticos de amplio espectro 57,1% de los casos; con estancia hospitalaria de 4,7 días (+/-2,4). Conclusión: Los fallecidos por COVID-19 presentaron neumonía grave bilateral, más frecuentes en varones, con factores de riesgo (adulto mayor, hipertensión arterial y obesidad), con alta necesidad de asistencia ventilatoria.

Introduction: The COVID-19 pandemic has caused more than 70 thousand deaths worldwide. Objective: To describe the characteristics of COVID-19 patients who died in a tertiary hospital. Methods: A descriptive study was carried out in the emergency service of the Hospital Rebagliati in Lima, Peru, which includes deceased patients with a positive result for SARS-CoV-2 infection diagnosed by PCR-TR until April 4, 2020. The medical history was reviewed. and hospital records looking for sociodemographic variables, clinical characteristics, radiological manifestations, treatment and evolution. Results: 14 cases were identified, 78.6% were male, average age 73.4 years (range 26 to 97). 21.4% of cases acquired the infection out of Peru. Risk factors were found in 92.9% of patients (more frequent elderly, hypertension and obesity). The most frequent symptoms were dyspnea, fever and cough, with illness time 8 days (+/- 3); signs of polypnea and respiratory rales. The most frequent laboratory findings were elevated C-reactive protein (average 22 mg / dL) and hypoxemia. The predominant radiological presentation was bilateral interstitial pulmonary infiltration in ground glass. 78.6% (11 of 14 cases) entered mechanical ventilation; 71.4% of the cases received azithromycin, 64.3% hydroxychloroquine and 57.1% broad-spectrum antibiotics; with a 4.7 day hospital stay (+/- 2.4). Conclusion: Those who died from COVID-19 presented bilateral severe pneumonia, more frequent in men, with risk factors (elderly, hypertension and obesity), with a high need for ventilatory assistance.