Microgel particles with pore structure and ligands distributed evenly throughout their matrices overcome the major limitations of protein purification systems: low ligand density on the immobilized matrix and protein access to those ligands. A straightforward synthetic scheme for a highly efficient microgel matrix is reported.
Background The utility of convalescent COVID-19 plasma (CCP) in the current pandemic is not well defined. We sought to evaluate safety and efficacy of CCP in severely or life threateningly ill COVID-19 patients when matched with a contemporaneous cohort. Methods Patients with severe or life threatening COVID-19 were treated with CCP according to FDA criteria, prioritization by an interdisciplinary team and based on CCP availability. Individual-level matched controls (1:1) were identified from patients admitted during the prior month when no CCP was available. Safety outcome was freedom from adverse transfusion reaction and efficacy outcome a composite of death or worsening O2 support. Demographic, clinical and laboratory data were analyzed by univariate and multivariable regression analyses accounting for matched design. Results Study patients (N=94, 47 matched pairs) were 62% male with mean age of 58 and 98% (90/94) were minority (53% Hispanic, 45% Black, non-Hispanic) in our inner-city population. Seven-day composite and mortality outcomes suggested a non-significant benefit in CCP treated patients (adjusted hazard ratio (aHR), 0.70; 95% confidence interval (CI), 0.23 to 2.12; P=0.52; aHR, 0.23; 95% CI, 0.04 to 1.51; P=0.13, respectively). Stratification by pre-transfusion mechanical ventilation status showed no differences between groups. No serious transfusion reactions occurred. Conclusion In this short-term matched cohort study, transfusion with CCP was safe and showed a non-significant association with study outcomes. Randomized and larger trials to identify appropriate timing and dosing of CCP in COVID-19 is warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT04420988
This phase I study evaluated the maximal tolerated dose of CPX-351 when administered sequentially with allogeneic hematopoietic stem cell transplantation (HSCT) in patients with refractory acute leukemia. CPX-351 is a novel liposomal formulation that combines cytosine arabinoside (ara-c) and daunorubicin in a fixed molar ratio of 5:1. Patients in cohorts of 3 were treated with CPX-351 followed by fludarabine and busulfan (Bu/Flu) conditioning at 4-week (schedule A) or 3-week (schedule B) intervals. CPX-351 doses were escalated in 20-U/m(2) increments starting at 60 U/m(2) for 3 doses. Of the 36 patients enrolled, 29 were able to undergo HSCT, and the other 7 (the majority on schedule A) did not proceed to HSCT because of rapid disease progression. The maximal tolerated dose of CPX-351 was not reached at the 120 U/m(2) × 3 dose level. All 29 patients who proceeded to HSCT demonstrated adequate neutrophil and platelet engraftment. The median follow-up on the study for all 36 patients was 205 days (range, 20 to 996 days). The 1-year cumulative incidence of relapse for the 36 patients was 60.1% (95% confidence interval [CI], 43.4% to 77.3%), and that of nonrelapse mortality was 23.8% (95% CI, 10.9% to 47.4%). The 1-year overall survival and leukemia-free survival were 37% (95% CI, 21% to 53%) and 27% (95% CI, 13% to 43%), respectively. Our data suggest that a phase II trial should incorporate CPX-351 120 U/m(2) × 3 dosing on schedule B. Patients with good performance status and those who achieve effective cytoreduction from CPX-351 derived the greatest benefit.
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