Ovid: Welcome to Ovid

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*.
Bennett-Guerrero, Elliott MD 1; Romeiser, Jamie L. PhD 1; Talbot, Lillian R. BS 2; Ahmed, Tahmeena MD 3; Mamone, Linda J. MD 3; Singh, Sunitha M. MD 4; Hearing, Janet C. PhD 5; Salman, Huda MD, PHD 6; Holiprosad, Dishaw D. BS 7; Freedenberg, Alex T. BS 7; Carter, Jason A. PhD 2; Browne, Nicholas J. BS 7; Cosgrove, Megan E. PhD 7; Shevik, Margaret E. BS 2; Generale, Laura M. BS 7; Andrew, Margaret A. BSN 8; Nachman, Sharon MD 9; Fries, Bettina C. MD 10; for the Stony Brook Medicine COVID Plasma Trial Group; Stony Brook Medicine COVID Plasma Trial Group are as follows: Investigators; Bennett-Guerrero, Elliott; Principal Investigator, Critical Care; Ahmed, Tahmeena; Pathology/Blood Bank; Fries, Bettina C.; Infectious Disease; Nachman, Sharon; Safety Monitor; Romeiser, Jamie; Biostatistics; Salman, Huda; Hematology; Senzel, Lisa; (Blood Bank; and; Spitzer, Eric; Pathology, Laboratory Services). Team 1 (Online Survey/In Person Scheduling); Caravella, Giuseppina; Team Leader; Harper, Laura; Kaell, Diana; Keister, Melanie; Komatsu, David; Lamb, Jessica; Lee, Deidre; O'Keefe, Jane; Pallai, Ajish; Roemer, Elizabeth; Scherl, William; Skinner, Sandra; and; Smith-McAllister, Leah; Team 2 (In Person Screening Visits); Rago, Molly; Team Leader; Brand, Margaret; Bryan, Andrew; Festa, Lauren; Fiore, Susan; Harbourne, Shannen; Hecker-Crawford, Audrey; Lavorna, Ann; McKenna, Caryn; Repetti, Robert; Roggemann, Curtis; Sahib, Haseena; Shevik, Margaret; Singh, Sunitha; Stein, Ruth; and; Vivas, Kathy; Team 3 (Patient/Recipient Screening, Plasma Administration, Data Capture); Andrew, Margaret; Team Leader; Anderson, Audrey; Arata, Joan; Baumeister, Marlene; Boudreau, Susan; Brill, Patricia; Daley, Noelle; Gearwar, Christine; Generale, Laura; Halper, Darcy; and; Healy, Erin J.; Letscher, Coleen; Madigan, Dawn; Markarian-Askinazi, Katherine; Mavarez-Martinez, Ana; Munoz, Sebastian; Pol, Christine; Propper, Grace; and; Holiprosad, Dishaw; and; Fernando, Rajeev; Seshan, Nandini; and; Pham, Sophia; Team M (Antibody Testing/Randomization):; Talbot, Lillian; Team Leader; Browne, Nicholas; Carter, Jason; Cosgrove, Megan; Freedenberg, Alex; and; Sisti, Andrew; Plaque Reduction Neutralization Assay: Janet Hearing. Regulatory (Investigational New Drug [IND] and Institutional Review Board [IRB] support); Grewal, Suman; (IND support); Vacchi-Suzzi, Caterina; (IRB support), and; Wong, Angie; Data and Safety Monitoring Board (DSMB); Califf, Robert; Bandarenko, Nicholas; and; McMahon, Timothy; (Chair) and; Hou, Wei; (unblinded DSMB statistician)
[Article] Critical Care Medicine. 49(7):1015-1025, July 2021.

(Format: HTML, PDF)

OBJECTIVES: Four 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.

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.