Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York: A Double-Blind Randomized Trial.
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Bennett-Guerrero Elliott, Romeiser Jamie L, Talbot Lillian R, Ahmed Tahmeena, Mamone Linda J, Singh Sunitha M, Hearing Janet C, Salman Huda, Holiprosad Dishaw D, Freedenberg Alex T, Carter Jason A, Browne Nicholas J, Cosgrove Megan E, Shevik Margaret E, Generale Laura M, Andrew Margaret A, Nachman Sharon, Fries Bettina C, 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, and, Team 2 (In Person Screening Visits), Team Leader, and, Team 3 (Patient/Recipient Screening, Plasma Administration, Data Capture), Team Leader, and, and, and, and, Team M (Antibody Testing/Randomization):, Team Leader, and, 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), and, (Chair) and, (unblinded DSMB statistician), 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 and Hematology and (Blood Bank and and and Pathology, Laboratory Services). Team 1 (Online Survey/In Person Scheduling) and Team Leader and and and Team 2 (In Person Screening Visits) and Team Leader and and and Team 3 (Patient/Recipient Screening, Plasma Administration, Data Capture) and Team Leader and and and and and and and and and Team M (Antibody Testing/Randomization): and Team Leader and and and Plaque Reduction Neutralization Assay: Janet Hearing. Regulatory (Investigational New Drug [IND] and Institutional Review Board [IRB] support) and (IND support) and (IRB support), and and Data and Safety Monitoring Board (DSMB) and and and (Chair) and and (unblinded DSMB statistician)
Аннотация
DESIGN: Double-blind randomized controlled trial.
SETTING: Hospital in New York.
PATIENTS: Patients with polymerase chain reaction documented coronavirus disease 2019 infection.
INTERVENTIONS: Patients 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 RESULTS: Enrollment 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.
CONCLUSIONS: Administration 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.