• Elliott Bennett-Guerrero, Jamie L Romeiser, Lillian R Talbot, Tahmeena Ahmed, Linda J Mamone, Sunitha M Singh, Janet C Hearing, Huda Salman, Dishaw D Holiprosad, Alex T Freedenberg, Jason A Carter, Nicholas J Browne, Megan E Cosgrove, Margaret E Shevik, Laura M Generale, Margaret A Andrew, Sharon Nachman, Bettina C Fries, Stony Brook Medicine COVID Plasma Trial Group, Stony Brook Medicine COVID Plasma Trial Group are as follows: Investigators, Principal Investigator, Critical Care, Pathology/Blood Bank, Infectious Disease, Safety Monitor, Biostatistics, Hematology, (Blood Bank, and, Pathology, Laboratory Services). Team 1 (Online Survey/In Person Scheduling), Team Leader, Team 2 (In Person Screening Visits), Team 3 (Patient/Recipient Screening, Plasma Administration, Data Capture), Team M (Antibody Testing/Randomization):, Plaque Reduction Neutralization Assay: Janet Hearing. Regulatory (Investigational New Drug [IND] and Institutional Review Board [IRB] support), (IND support), (IRB support), and, Data and Safety Monitoring Board (DSMB), (Chair) and, (unblinded DSMB statistician), and Stony Brook Medicine COVID Plasma Trial Group and Stony Brook Medicine COVID Plasma Trial Group are as follows: Investigators and Principal Investigator, Critical Care and Pathology/Blood Bank and Infectious Disease and Safety Monitor and Biostatistics an.
• Department of Anesthesiology, Stony Brook University, Stony Brook, NY.
• Crit. Care Med. 2021 Jul 1; 49 (7): 101510251015-1025.

ObjectivesFour peer-reviewed publications have reported results from randomized controlled trials of convalescent plasma for coronavirus disease 2019 infection; none were conducted in the United States nor used standard plasma as a comparator. To determine if administration of convalescent plasma to patients with coronavirus disease 2019 increases antibodies to severe acute respiratory syndrome coronavirus 2 and improves outcome.DesignDouble-blind randomized controlled trial.SettingHospital in New York.PatientsPatients with polymerase chain reaction documented coronavirus disease 2019 infection.InterventionsPatients were randomized (4:1) to receive 2 U of convalescent plasma versus standard plasma. Antibodies to severe acute respiratory syndrome coronavirus 2 were measured in plasma units and in trial recipients.Measurements And Main ResultsEnrollment was terminated after emergency use authorization was granted for convalescent plasma. Seventy-four patients were randomized. At baseline, mean (sd) Acute Physiology and Chronic Health Evaluation II score (23.4 [5.6] and 22.5 [6.6]), percent of patients intubated (19% and 20%), and median (interquartile range) days from symptom onset to randomization of 9 (6-18) and 9 (6-15), were similar in the convalescent plasma versus standard plasma arms, respectively. Convalescent plasma had high neutralizing activity (median [interquartile range] titer 1:526 [1:359-1:786]) and its administration increased antibodies to severe acute respiratory syndrome coronavirus 2 by 14.4%, whereas standard plasma administration led to an 8.6% decrease (p = 0.005). No difference was observed for ventilator-free days through 28 days (primary study endpoint): median (interquartile range) of 28 (2-28) versus 28 (0-28; p = 0.86) for the convalescent plasma and standard plasma groups, respectively. A greater than or equal to 2 point improvement in the World Health Organization scale was achieved by 20% of subjects in both arms (p = 0.99). All-cause mortality through 90 days was numerically lower in the convalescent plasma versus standard plasma groups (27% vs 33%; p = 0.63) but did not achieve statistical significance. A key prespecified subgroup analysis of time to death in patients who were intubated at baseline was statistically significant; however, sample size numbers were small.ConclusionsAdministration of convalescent plasma to hospitalized patients with coronavirus disease 2019 infection increased antibodies to severe acute respiratory syndrome coronavirus disease 2 but was not associated with improved outcome.Copyright © 2021 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

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