RESUMEN
BACKGROUND: Therapies to interrupt the progression of early coronavirus disease 2019 (Covid-19) remain elusive. Among them, convalescent plasma administered to hospitalized patients has been unsuccessful, perhaps because antibodies should be administered earlier in the course of illness. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of convalescent plasma with high IgG titers against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in older adult patients within 72 hours after the onset of mild Covid-19 symptoms. The primary end point was severe respiratory disease, defined as a respiratory rate of 30 breaths per minute or more, an oxygen saturation of less than 93% while the patient was breathing ambient air, or both. The trial was stopped early at 76% of its projected sample size because cases of Covid-19 in the trial region decreased considerably and steady enrollment of trial patients became virtually impossible. RESULTS: A total of 160 patients underwent randomization. In the intention-to-treat population, severe respiratory disease developed in 13 of 80 patients (16%) who received convalescent plasma and 25 of 80 patients (31%) who received placebo (relative risk, 0.52; 95% confidence interval [CI], 0.29 to 0.94; P = 0.03), with a relative risk reduction of 48%. A modified intention-to-treat analysis that excluded 6 patients who had a primary end-point event before infusion of convalescent plasma or placebo showed a larger effect size (relative risk, 0.40; 95% CI, 0.20 to 0.81). No solicited adverse events were observed. CONCLUSIONS: Early administration of high-titer convalescent plasma against SARS-CoV-2 to mildly ill infected older adults reduced the progression of Covid-19. (Funded by the Bill and Melinda Gates Foundation and the Fundación INFANT Pandemic Fund; Dirección de Sangre y Medicina Transfusional del Ministerio de Salud number, PAEPCC19, Plataforma de Registro Informatizado de Investigaciones en Salud number, 1421, and ClinicalTrials.gov number, NCT04479163.).
Asunto(s)
COVID-19/terapia , Inmunoglobulina G/sangre , Insuficiencia Respiratoria/prevención & control , SARS-CoV-2/inmunología , Anciano , Anciano de 80 o más Años , Transfusión de Componentes Sanguíneos , COVID-19/complicaciones , Progresión de la Enfermedad , Método Doble Ciego , Femenino , Humanos , Inmunización Pasiva , Análisis de Intención de Tratar , Estimación de Kaplan-Meier , Masculino , Insuficiencia Respiratoria/etiología , Índice de Severidad de la Enfermedad , Sueroterapia para COVID-19RESUMEN
Patient safety is a current and ongoing problem of increasing importance in healthcare. The implementation of a safety culture leads to behavioral change in all processes and responsibility centers. It means a long, slow, arduous path and requires effort, persistence and commitment, but it is increasingly necessary and indispensable in hospital management.
La seguridad del paciente es problema vigente y actual, de gran importancia en la atención sanitaria. La implantación de una cultura de seguridad lleva a un cambio de hábitos en todos los procesos y centros de responsabilidad. Es un camino extenso, lento, trabajoso, que exige esfuerzo, persistencia y compromiso, pero cada vez más necesario e imprescindible en la gestión hospitalaria.
Asunto(s)
Atención a la Salud/organización & administración , Administración Hospitalaria/normas , Seguridad del Paciente , Atención a la Salud/normas , Humanos , Administración de la Seguridad/organización & administraciónRESUMEN
La seguridad del paciente es problema vigente y actual, de gran importancia en la atención sanitaria. La implantación de una cultura de seguridad lleva a un cambio de hábitos en todos los procesos y centros de responsabilidad. Es un camino extenso, lento, trabajoso, que exige esfuerzo, persistencia y compromiso, pero cada vez más necesario e imprescindible en la gestión hospitalaria.
Patient safety is a current and ongoing problem of increasing importance in healthcare. The implementation of a safety culture leads to behavioral change in all processes and responsibility centers. It means a long, slow, arduous path and requires effort, persistence and commitment, but it is increasingly necessary and indispensable in hospital management.
