Patients were excluded if: there was a history of prior severe reactions to transfusion of blood products with imputability of probable or definite, as defined by the CDC National Healthcare Safety Network Hemovigilance Moduleīriefly, convalescent plasma was obtained by apheresis and processed by standard blood banking protocols under Houston Methodist human subjects protocol PRO00025121. Fewer patients with advanced disease (intubated/on extracorporeal membrane oxygenation) were enrolled later in the study. As the pandemic progressed in the Houston metropolitan region and awareness regarding convalescent plasma as a treatment option increased, recruitment into the study transitioned to the study investigators screening requests for enrollment of patients from treatment teams across the hospital system. Patient recruitment early in the study involved investigators reaching out to treatment teams and patients.
Life-threatening disease was defined as one or more of the following: respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Severe disease was defined as one or more of the following: shortness of breath (dyspnea), respiratory rate ≥30/minute, blood oxygen saturation ≤93% (on room air), partial pressure of arterial oxygen/fraction of inspired oxygen ratio 50% within 24 to 48 hours (of screening assessment). Patients were eligible for this study if they had severe and/or life-threatening COVID-19 (US Food and Drug Administration,, last accessed July 11, 2020). These data suggest that treatment of COVID-19 with high anti–receptor binding domain IgG titer convalescent plasma is efficacious in early-disease patients. The analysis showed a significant reduction ( P = 0.047) in mortality within 28 days, specifically in patients transfused within 72 hours of admission with plasma with an anti-spike protein receptor binding domain titer of ≥1:1350. Variability in the timing of transfusion relative to admission and titer of antibodies of plasma transfused allowed for analysis in specific matched cohorts. Matching criteria included age, sex, body mass index, comorbidities, and baseline ventilation requirement 48 hours from admission, and in a second matching analysis, ventilation status at day 0. Of the 316 transfused patients, 136 met a 28-day outcome and were matched to 251 non-transfused control COVID-19 patients. We present herein the results of an interim analysis of 316 patients enrolled at Houston Methodist hospitals from March 28 to July 6, 2020. We are conducting a prospective, propensity score–matched study assessing the efficacy of COVID-19 convalescent plasma transfusion versus standard of care as treatment for severe and/or critical COVID-19. Transfusion of convalescent plasma collected from donors who have recovered from COVID-19 is among many approaches being studied as potentially efficacious therapy. Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2, has spread globally, and proven treatments are limited.
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