The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset (NCT04348656). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm—relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94–1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02–1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57–0.95 and OR = 0.66, 95% CI 0.50–0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14–2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.
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3921 adults randomly selected from across Great Britain were interviewed. Subjects were asked to assess a selection of 10 out of 200 vignettes. Each vignette contained four elements: a category of individual; access to some or all of the health record; specified purpose; and level of patient identifier. Subjects were asked to say how happy they would be to allow access to their health record in the circumstances described.The public were generally happy to provide access to health information. For almost a third of vignettes, subjects said that they would be very happy to allow access to their health information. 9.1% of subjects said that they would be very happy to allow access within all of the vignettes that they were asked to assess. There was however, a significant minority of responses (11.6%) to vignettes where subjects said that they would be very unhappy to allow access. In addition 2.1% of individuals said that they were very unhappy with all of the vignettes presented to them. Individuals from higher social groups, older people and males were more likely to be happy with access to their health information. The individual requesting information was the most important factor determining permission to access health information. Subjects were happier to release anonymised rather than personally identifiable data. Content of the information to be released did not seem to be that important, even when the health record contained sensitive information. With the exception of teaching students, the use of the information wasn't an important determinant of consent.Despite a level of support for use of health information in most circumstances, this doesn't mean that patients don't want to be asked for consent, nor that the views of the small minority can be ignored. The ethical and policy implications of these findings will be discussed.
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