RESUMO
BACKGROUNDAlthough convalescent plasma has been widely used to treat severe coronavirus disease 2019 (COVID-19), data from randomized controlled trials that support its efficacy are limited.METHODSWe conducted a randomized, double-blind, controlled trial among adults hospitalized with severe and critical COVID-19 at 5 sites in New York City (USA) and Rio de Janeiro (Brazil). Patients were randomized 2:1 to receive a single transfusion of either convalescent plasma or normal control plasma. The primary outcome was clinical status at 28 days following randomization, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population.RESULTSOf 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to receive normal control plasma. At 28 days, no significant improvement in the clinical scale was observed in participants randomized to convalescent plasma (OR 1.50, 95% confidence interval [CI] 0.83-2.68, P = 0.180). However, 28-day mortality was significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73 [24.6%], OR 0.44, 95% CI 0.22-0.91, P = 0.034). The median titer of anti-SARS-CoV-2 neutralizing antibody in infused convalescent plasma units was 1:160 (IQR 1:80-1:320). In a subset of nasopharyngeal swab samples from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected.CONCLUSIONIn adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in day 28 clinical status. However, convalescent plasma was associated with significantly improved survival. A possible explanation is that survivors remained hospitalized at their baseline clinical status.TRIAL REGISTRATIONClinicalTrials.gov, NCT04359810.FUNDINGAmazon Foundation, Skoll Foundation.
Assuntos
COVID-19/terapia , SARS-CoV-2 , Adulto , Idoso , Idoso de 80 Anos ou mais , Brasil/epidemiologia , COVID-19/imunologia , COVID-19/mortalidade , Método Duplo-Cego , Feminino , Humanos , Imunização Passiva , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque/epidemiologia , Pandemias , SARS-CoV-2/imunologia , Índice de Gravidade de Doença , Resultado do Tratamento , Soroterapia para COVID-19RESUMO
BACKGROUND: Zika virus (ZIKV) is transmitted by Aedes mosquitos and can result in severe congenital and adult neurologic abnormalities. ZIKV has rapidly spread northward through Central America and the Caribbean and autochthonous cases have been identified in the continental United States. High rates of ZIKA RNA positivity were detected in blood donors during previous epidemics. ZIKV transmission by transfused blood from healthy donor components has been a growing concern. STUDY DESIGN AND METHODS: Individual-donation aliquots of plasma from volunteer blood donors were tested individually with an investigational Procleix ZIKV assay. Initially reactive samples were tested for ZIKV RNA in plasma and red blood cells (RBCs) and for ZIKV-specific antibodies in serum. A confirmed positive classification required confirmation of RNA and/or detection of ZIKV antibodies in index and/or follow-up samples. RESULTS: Between September 19 and November 30, 2016, a total of 466,834 donations were screened for ZIKV RNA. Five donors (one in approx. 93,000) were reactive for ZIKV RNA by both the Procleix ZIKV assay and supplemental testing. The donations were collected outside areas considered as having active transmission, and all five donors had travel exposures. A lookback case demonstrated no infection despite transfusion of a Zika IgG-positive platelet (PLT) component with probable low levels of ZIKV RNA. CONCLUSIONS: This report describes the first ZIKV-positive donors detected outside areas with active transmission. These donors most likely represent travel-acquired "tail-end infections" with prolonged RBC-associated ZIKV RNA. The lack of transmission to the recipient of an apheresis PLT may suggest that these units are not infectious.
Assuntos
Doadores de Sangue , RNA Viral/sangue , Infecção por Zika virus , Zika virus , Adulto , Região do Caribe/epidemiologia , América Central/epidemiologia , Feminino , Humanos , Masculino , Infecção por Zika virus/sangue , Infecção por Zika virus/etnologia , Infecção por Zika virus/transmissãoRESUMO
OBJECTIVE: To evaluate coagulopathy in pediatric trauma patients on presentation to the emergency department, and to quantify the relationship with mortality. STUDY DESIGN: Pediatric trauma patients requiring a blood transfusion (red blood cells, fresh frozen plasma, platelets, or cryoprecipitate) within 24 hours of arrival were included. Coagulation values on emergency department arrival were analyzed, as were clinical details and outcome. RESULTS: A total of 102 children (mean age, 6 years; mean injury severity score 22, mean Glascow Coma Scale 7, 80% blunt trauma victims) were studied over a 4 year period. An abnormal prothrombin time was found in 72%, partial thromboplastin time in 38%, fibrinogen in 52%, hemoglobin in 58%, and platelet count in 23%. An abnormal prothrombin time, partial thromboplastin time, and platelet count were strongly associated with mortality (P=.005, .001, and <.0001, respectively) and remained significantly associated in multivariate analysis after adjusting for injury severity score. CONCLUSIONS: Coagulopathy is prevalent in pediatric trauma patients ill enough to require a transfusion and is strongly associated with mortality. Studies are needed to determine whether early coagulation factor replacement and the institution of massive transfusion protocols may improve outcomes in these patients.
Assuntos
Transtornos da Coagulação Sanguínea/diagnóstico , Reação Transfusional , Ferimentos e Lesões/terapia , Transtornos da Coagulação Sanguínea/sangue , Transtornos da Coagulação Sanguínea/epidemiologia , Criança , Pré-Escolar , Feminino , Seguimentos , Humanos , Escala de Gravidade do Ferimento , Masculino , Tempo de Tromboplastina Parcial , Prevalência , Tempo de Protrombina , Resultado do Tratamento , Ferimentos e Lesões/mortalidadeRESUMO
OBJECTIVE: To test the hypothesis that red blood cell (RBC) transfusions increase the risk of necrotizing enterocolitis (NEC) in premature infants, we investigated whether the risk of "transfusion-associated" NEC is higher in infants with lower hematocrits and advanced postnatal age. STUDY DESIGN: Retrospective comparison of NEC patients and control patients born at < 34 weeks gestation. RESULTS: The frequency of RBC transfusions was similar in NEC patients (47/93, 51%) and control patients (52/91, 58%). Late-onset NEC (> 4 weeks of age) was more frequently associated with a history of transfusion(s) than early-onset NEC (adjusted OR, 6.7; 95% CI, 1.5 to 31.2; P = .02). Compared with nontransfused patients, RBC-transfused patients were born at earlier gestational ages, had greater intensive care needs (including at the time of onset of NEC), and longer hospital stay. A history of RBC transfusions within 48-hours before NEC onset was noted in 38% of patients, most of whom were extremely low birth weight infants. CONCLUSIONS: In most patients, RBC transfusions were temporally unrelated to NEC and may be merely a marker of overall severity of illness. However, the relationship between RBC transfusions and NEC requires further evaluation in extremely low birth weight infants using a prospective cohort design.