ABSTRACT
BACKGROUNDPassive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19. Evidence from controlled clinical trials is inconclusive.METHODSWe conducted a randomized, open-label, controlled clinical trial at 27 hospitals in Spain. Patients had to be admitted for COVID-19 pneumonia within 7 days from symptom onset and not on mechanical ventilation or high-flow oxygen devices. Patients were randomized 1:1 to treatment with CP in addition to standard of care (SOC) or to the control arm receiving only SOC. The primary endpoint was the proportion of patients in categories 5 (noninvasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), or 7 (death) at 14 days. Primary analysis was performed in the intention-to-treat population.RESULTSBetween April 4, 2020, and February 5, 2021, 350 patients were randomly assigned to either CP (n = 179) or SOC (n = 171). At 14 days, proportion of patients in categories 5, 6, or 7 was 11.7% in the CP group versus 16.4% in the control group (P = 0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in the CP group versus 17.0% in the control group (P = 0.021). The difference in overall survival did not reach statistical significance (HR 0.46, 95% CI 0.19-1.14, log-rank P = 0.087).CONCLUSIONCP showed a significant benefit in preventing progression to noninvasive ventilation or high-flow oxygen, invasive mechanical ventilation or ECMO, or death at 28 days. The effect on the predefined primary endpoint at 14 days and the effect on overall survival were not statistically significant.TRIAL REGISTRATIONClinicaltrials.gov, NCT04345523.FUNDINGGovernment of Spain, Instituto de Salud Carlos III.
Subject(s)
COVID-19/therapy , SARS-CoV-2 , Aged , COVID-19/mortality , COVID-19/physiopathology , Combined Modality Therapy , Disease Progression , Female , Hospitalization , Humans , Immunization, Passive/adverse effects , Kaplan-Meier Estimate , Male , Middle Aged , Odds Ratio , Pandemics , Spain/epidemiology , Treatment Outcome , COVID-19 SerotherapyABSTRACT
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Subject(s)
Female , Middle Aged , Humans , Vitamin B 12/metabolism , Metabolic Diseases/diagnosis , Dietary Vitamins/metabolism , Diagnosis, DifferentialABSTRACT
Antecedentes y objetivos: Para reducir el riesgo de transmisión viral por la transfusión de componentes plasmáticos, se emplean métodos de inactivación viral. Se estudia si el proceso de fotoinactivación del Plasma Fresco Congelado (PFC) con Azul de Metileno disminuye la actividad de los factores de coagulación del mismo, valorando el cumplimiento de los criterios de calidad y si pueden ser utilizados como materia prima para la producción de crioprecipitados. Material y métodos: Se preparan 24 "pooles" de dos unidades de plasma, separándose cada uno en dos alícuotas, una se somete a fotoinactivación y la otra es congelada y reservada como control. Se determina la actividad de los factores de coagulación FV FVIIIc y Fibrinógeno en las dos muestras de PFC. Para el análisis de datos se empleó el paquete estadístico SPSS 9.0, realizándose la prueba "t" Student para datos apareados de la actividad de los factores. Resultados: La disminución de los factores del PFC inactivado frente a PFC control fue significativa (p<0,01), siendo esta disminución de 28 UI/dl para FVIIlc, 26 UI/dl para FV y 32 mg/dl para el Fibrinógeno. Conclusiones: 1º. Existe una pérdida significativa de actividad del factor VIIIc en el plasma fotoinactivado. 2º. No debería ser utilizado el PFC fotoinactivado para la obtención de Crioprecipitado (AU)
