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1.
N Engl J Med ; 384(7): 610-618, 2021 02 18.
Artigo em Inglês | MEDLINE | ID: mdl-33406353

RESUMO

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.).


Assuntos
COVID-19/terapia , Imunoglobulina G/sangue , Insuficiência Respiratória/prevenção & controle , SARS-CoV-2/imunologia , Idoso , Idoso de 80 Anos ou mais , Transfusão de Componentes Sanguíneos , COVID-19/complicações , Progressão da Doença , Método Duplo-Cego , Feminino , Humanos , Imunização Passiva , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Insuficiência Respiratória/etiologia , Índice de Gravidade de Doença , Soroterapia para COVID-19
2.
Acta Med Acad ; 49(2): 191-197, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33189124

RESUMO

This review addresses differences in respiratory syncytial virus (RSV) lower respiratory tract illness (LRTI) between industrialized and developing countries and provides observations associated with the dissimilar consequences of viral infection in both environments. RSV LRTI is an important cause of morbidity and mortality in infants worldwide. Its burden is highest in developing countries, where most hospitalizations and mortality occur. Palivizumab has been approved for disease prevention in premature infants in numerous countries but its cost and requirement for several doses hampers its routine use. The significant gap between low- and high-income countries in mortality rates stresses the need to identify specific risk factors for RSV LRTI prevention in different populations. CONCLUSION: RSV LTRI continues to be a serious problem for industrialised and developing countries, although mortality occurs preferentially in the latter. Several vaccines and monoclonal antibodies to prevent severe disease are advancing steadily in late phase trials. The next decade may witness a change in the landscape of RSV infections in young infants.


Assuntos
Asma/epidemiologia , Bronquiolite Viral/epidemiologia , Países em Desenvolvimento , Pneumonia/epidemiologia , Infecções por Vírus Respiratório Sincicial/epidemiologia , Antivirais/economia , Antivirais/uso terapêutico , Bronquiolite Viral/prevenção & controle , Coinfecção , Custos de Medicamentos , Carga Global da Doença , Hospitalização/estatística & dados numéricos , Humanos , Recém-Nascido Prematuro , Palivizumab/economia , Palivizumab/uso terapêutico , Infecções por Vírus Respiratório Sincicial/prevenção & controle
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