Protocolo para la administración de plasma hiperinmune a pacientes covid-19

Resumen La transfusión de plasma hiperinmune o convaleciente en pacientes internados, es un problema en la actualidad porque existe desconocimiento de protocolos donde se determine la cuantificación de anticuerpos, tipo de donante, método de obtención y momento de administración. Objetivo. Elaborar un protocolo de administración de plasma hiperinmune en pacientes Covid-19, internados en el Hospital "Presidente Germán Busch" de Trinidad, gestión 2020. Materiales y métodos. Investigación descriptiva, se realizó una encuesta y revisión documental a población de 26 personales de salud y 25 pacientes respectivamente. Resultados. El desconocimiento de protocolos por parte del personal de salud fue de 73,1%, considerando que el 61% cuentan con postgrados. De los pacientes transfundidos el 60% fallecieron, siendo de la tercera edad, sexo masculino y en estado crítico. El 28% fueron dados de alta hospitalaria, tomando en cuenta que fueron transfundidos en estado moderado. Conclusiones. El porcentaje de desconocimiento de protocolo de administración de plasma hiperinmune y los fallecimientos de pacientes transfundidos son elevados, es por ello que se propone la elaboración de un protocolo de administración de plasma hiperinmune para pacientes Covid-19, que se caracterice por: estudio previo de los donantes, método de obtención, títulos de anticuerpos y momento de administración del hemocomponente.

Abstract Transfusion of hyperimmune or convalescent plasma in hospitalized patients is currently a problem because there is a lack of knowledge of protocols to determine the quantification of antibodies, type of donor, method of obtaining and time of administration. Objective. To develop a protocol for the administration of hyperimmune plasma in Covid-19 patients, admitted to the Hospital "Presidente Germán Busch" in Trinidad, management 2020. Materials and methods: Descriptive research, a survey and documentary review were carried out on a population of 26 health personnel and 25 patients respectively. Results. Lack of knowledge of protocols by health personnel was 73.1%, and 61% have postgraduate degrees. Of the transfused patients, 60% died, being elderly, male and in critical condition. 28% were discharged from hospital, taking into account that they were transfused in moderate condition. Conclusions. The percentage of ignorance of the hyperimmune plasma administration protocol and the deaths of transfused patients are high, which is why the development of a hyperimmune plasma administration protocol for Covid-19 patients is proposed, characterized by: study previous donor, method of obtaining, antibody titers and time of administration of the blood component.

Resumo A transfusão de plasma hiperimune ou convalescente em pacientes hospitalizados é atualmente um problema, pois há falta de conhecimento de protocolos para determinar a quantificação de anticorpos, tipo de doador, método de obtenção e tempo de administração. Objetivo: Desenvolver um protocolo para a administração de plasma hiperimune em pacientes Covid-19, internados no Hospital "Presidente Germán Busch" em Trinidad, gestão 2020. Materiais e métodos. Pesquisa descritiva, levantamento e revisão documental foram realizados em uma população de 26 profissionais de saúde e 25 pacientes, respectivamente. Resultados. O desconhecimento dos protocolos por parte dos profissionais de saúde foi de 73,1%, e 61% possuem pós-graduação. Dos pacientes transfundidos, 60% morreram, sendo idosos, do sexo masculino e em estado crítico. 28% tiveram alta hospitalar, levando-se em consideração que foram transfundidos em estado moderado. Conclusões. O percentual de desconhecimento do protocolo de administração de plasma hiperimune e os óbitos de pacientes transfundidos são elevados, razão pela qual é proposto o desenvolvimento de um protocolo de administração de plasma hiperimune para pacientes com Covid-19, caracterizado por: estudo de doador prévio, método de obtenção, títulos de anticorpos e tempo de administração do hemocomponente.

El plasma de convalecientes como un tratamiento potencial en pacientes con COVID-19 / Convalescent plasma as potential treatment for COVID-19 patients

Introducción: El plasma de convalecientes es una inmunoterapia pasiva que se ha usado para el tratamiento y prevención de muchas enfermedades infecciosas por más de un siglo. Dada la falta de tratamiento específico para el nuevo coronavirus SARS-CoV-2, el plasma de convalecientes es una alternativa terapéutica potencial contra la COVID-19. Objetivo: Realizar una revisión del empleo del plasma de convalecientes como alternativa terapéutica a la COVID-19. Desarrollo: Se empleó la estrategia de búsqueda del tema; consultando las bases de datos Pubmed, SciELO, Lilacs, Cochrane Library y Web of Science. El plasma de convalecientes ha mostrado efectividad en el tratamiento de varias enfermedades virales. Así, la evidencia sobre su uso en los pacientes con COVID-19 es escasa, aunque se han obtenido resultados alentadores, pero no concluyentes por falta de un número mayor ensayos clínicos. Al mismo tiempo, Cuba incluye en sus protocolos de actuación contra la COVID-19 este tratamiento. Conclusiones: Esta alternativa resulta una herramienta inmunoterapéutica en los pacientes con la COVID-19, ya que mejora el estado clínico y disminuir la tasa de letalidad. Sin embargo, se necesitan más ensayos clínicos controlados y aleatorizados que afirmen su efectividad y seguridad(AU)

Introduction: Convalescent plasma is a form of passive immunotherapy which has been used for the treatment and prevention of many infectious diseases for more than one century. Given the absence of a specific treatment for the novel coronavirus SARS-CoV-2, convalescent plasma is a potential therapeutic alternative against COVID-19. Objective: Carry out a review about the use of convalescent plasma as a therapeutic alternative against COVID-19. Discussion: A search was conducted about the topic in the databases Pubmed, SciELO, Lilacs, Cochrane Library and Web of Science. Convalescent plasma has been shown to be effective in the treatment of several viral diseases. However, evidence of its use in COVID-19 patients is scant. Promising results have been obtained, though, but they are not conclusive due to the need of a larger number of clinical trials. In Cuba this treatment is included among the clinical management protocols for COVID-19. Conclusions: This alternative is an immunotherapeutic tool for the treatment of COVID-19 patients, since it improves their clinical status and reduces lethality rates. However, more controlled and randomized clinical trials are required confirming its effectiveness and safety(AU)

Streamlined downstream process for efficient and sustainable (Fab)2 antivenom preparation

Antivenoms are the only validated treatment against snakebite envenoming. Numerous drawbacks pertaining to their availability, safety and efficacy are becoming increasingly evident due to low sustainability of current productions. Technological innovation of procedures generating therapeutics of higher purity and better physicochemical characteristics at acceptable cost is necessary. The objective was to develop at laboratory scale a compact, feasible and economically viable platform for preparation of equine F(ab')2 antivenom against Vipera ammodytes ammodytes venom and to support it with efficiency data, to enable estimation of the process cost-effectiveness. Methods: The principle of simultaneous caprylic acid precipitation and pepsin digestion has been implemented into plasma downstream processing. Balance between incomplete IgG breakdown, F(ab')2 over-digestion and loss of the active drug's protective efficacy was achieved by adjusting pepsin to a 1:30 substrate ratio (w/w) and setting pH at 3.2. Precipitation and digestion co-performance required 2 h-long incubation at 21 °C. Final polishing was accomplished by a combination of diafiltration and flow-through chromatography. In vivo neutralization potency of the F(ab')2 product against the venom's lethal toxicity was determined. Results: Only three consecutive steps, performed under finely tuned conditions, were sufficient for preservation of the highest process recovery with the overall yield of 74%, comparing favorably to others. At the same time, regulatory requirements were met. Final product was aggregate- and pepsin-free. Its composition profile was analyzed by mass spectrometry as a quality control check. Impurities, present in minor traces, were identified mostly as IgG/IgM fragments, contributing to active drug. Specific activity of the F(ab')2 preparation with respect to the plasma was increased 3.9-fold. Conclusion: A highly streamlined mode for production of equine F(ab')2 antivenom was engineered. In addition to preservation of the highest process yield and fulfillment of the regulatory demands, performance simplicity and rapidity in the laboratory setting were demonstrated. Suitability for large-scale manufacturing appears promising.(AU)