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BACKGROUND: It is unknown whether convalescent immunoglobulins (cIgGs) are better than convalescent plasma (CP) for patients with coronavirus 2019 (COVID-19). METHODS: In this randomized controlled trial, we assigned high risk COVID-19 patients with ≤10 days of symptoms, to receive cIgGs or CP. The primary endpoint was improvement on day 14 according to the World Health Organization scale. Secondary endpoints were survival on day 14, and improvement, survival, and percent of ventilated patients on day 28, and treatment response in unvaccinated and vaccinated patients. RESULTS: A total of 319 patients were included: 166 received cIgGs and 153 CP. Median age was 64 to 66 years. A total of 112 patients (67.5%) in the cIgG group and 103 patients (67.3%) in the CP group reached the primary endpoint. Difference between groups was 0.1 (95% confidence interval, -10.1 to 10.4; P = .026), failing to reach noninferiority. More patients receiving cIgG improved by day 28 (136 patients [81.9%] and 108 patients [70.6%], respectively; 95% confidence interval, 1.9-20.7; P < .001; for superiority P = .018). Seventeen patients in the cIgG group (10.2%) and 25 patients (16.3%) in the CP group required mechanical ventilation (P = .136). Sixteen (9.6%) and 23 (15%) patients, respectively, died (P = .172). More unvaccinated patients improved by day 28 in the cIgG group (84.1% vs 66.1%; P = .024), and survival was better in the cIgG group (89.9% vs 77.4%; P = .066). CONCLUSIONS: cIgGs failed to reach the primary noninferiority endpoint on day 14 but was superior to CP on day 28. Survival and improvement by day 28 in unvaccinated patients treated with cIgGs were better. In the face of new variants, cIgGs are a viable option for treating COVID-19. TRIAL REGISTRATION NUMBER: My Trials MOH_2021-01-14_009667.
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COVID-19 , Humanos , Persona de Mediana Edad , Anciano , COVID-19/terapia , SARS-CoV-2 , Inmunización Pasiva/efectos adversos , Resultado del Tratamiento , Sueroterapia para COVID-19 , InmunoglobulinasRESUMEN
INTRODUCTION: The classical doctrine of mass toxicological events provides general guidelines for the management of a wide range of "chemical" events. The guidelines include provisions for the: (1) protection of medical staff with personal protective equipment; (2) simple triage of casualties; (3) airway protection and early intubation; (4) undressing and decontamination at the hospital gates; and (5) medical treatment with antidotes, as necessary. A number of toxicological incidents in Israel during the summer of 2005 involved chlorine exposure in swimming pools. In the largest event, 40 children were affected. This study analyzes its medical management, in view of the Israeli Guidelines for Mass Toxicological Events. METHODS: Data were collected from debriefings by the Israeli Home Front Command, emergency medical services (EMS), participating hospitals, and hospital chart reviews. The timetable of the event, the number and severity of casualties evacuated to each hospital, and the major medical and logistical problems encountered were analyzed according to the recently described methodology of Disastrous Incident Systematic Analysis Through-Components, Interactions, Results (DISAST-CIR). RESULTS: The first ambulance arrived on-scene seven minutes after the first call. Emergency medical services personnel provided supplemental oxygen to the victims at the scene and en route when required. Forty casualties were evacuated to four nearby hospitals. Emergency medical services classified 26 patients as mildly injured, 13 as mild-moderate, and one as moderate, suffering from pulmonary edema. Most children received bronchodilators and steroids in the emergency room; 20 were hospitalized. All were treated in pediatric emergency rooms. None of the hospitals deployed their decontamination sites. CONCLUSIONS: Event management differed from the standard Israeli toxicological doctrine. It involved EMS triage of casualties to a number of medical centers, treatment in pediatric emergency departments, lack of use of protective gear, and omission of decontamination prior to emergency department entrance. Guidelines for mass toxicological events must be tailored to unique scenarios, such as chlorine intoxications at swimming pools, and for specific patient populations, such as children. All adult emergency departments always should be prepared and equipped for taking care of pediatric patients.
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Compuestos de Cloro/toxicidad , Servicio de Urgencia en Hospital/estadística & datos numéricos , Exposición a Riesgos Ambientales/efectos adversos , Incidentes con Víctimas en Masa , Piscinas , Triaje , Adolescente , Factores de Edad , Niño , Protección a la Infancia , Preescolar , Femenino , Humanos , Lactante , Recién Nacido , Israel , MasculinoRESUMEN
In December 1999, a group of emergency physicians from the United States, Israel, and Ethiopia met for the Second Annual Symposium on Emergency Medicine and to perform an initial evaluation of the prehospital care system in Addis Ababa. The symposium was structured into a workshop on prehospital care and a clinical seminar for emergency medicine providers. This article describes the current prehospital infrastructure in Addis Ababa, Ethiopia. This serves as the basis for more specific needs assessments and training interventions, which are ongoing. The authors present a list of priorities for the development of an emergency medical services (EMS) system for Addis Ababa that was generated in partnership with local government and the World Health Organization. The article contrasts these initial recommendations with those found in the literature on the development of EMS systems in developing nations.