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*. Issue 7 (July 2021)

• Record Type: Journal Article
• Authors: 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.; Bennett-Guerrero, Elliott; Ahmed, Tahmeena; Fries, Bettina C.; Nachman, Sharon; Romeiser, Jamie; Salman, Huda; Senzel, Lisa; Spitzer, Eric; Caravella, Giuseppina; Harper, Laura; Kaell, Diana; Keister, Melanie; Komatsu, David; Lamb, Jessica; Lee, Deidre; O'Keefe, Jane; Pallai, Ajish; Roemer, Elizabeth; Scherl, William; Skinner, Sandra; Smith-McAllister, Leah; Rago, Molly; 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; Vivas, Kathy; Andrew, Margaret; Anderson, Audrey; Arata, Joan; Baumeister, Marlene; Boudreau, Susan; Brill, Patricia; Daley, Noelle; Gearwar, Christine; Generale, Laura; Halper, Darcy; Healy, Erin J.; Letscher, Coleen; Madigan, Dawn; Markarian-Askinazi, Katherine; Mavarez-Martinez, Ana; Munoz, Sebastian; Pol, Christine; Propper, Grace; Holiprosad, Dishaw; Fernando, Rajeev; Seshan, Nandini; Pham, Sophia; Talbot, Lillian; Browne, Nicholas; Carter, Jason; Cosgrove, Megan; Freedenberg, Alex; Sisti, Andrew; Grewal, Suman; Vacchi-Suzzi, Caterina; Wong, Angie; Califf, Robert; Bandarenko, Nicholas; McMahon, Timothy; Hou, Wei;
• Is Part Of: Critical care medicine. Volume 49:Issue 7(2021)
• Publication Date: 2021-07
• Subjects: convalescent plasma -- coronavirus disease 2019 -- infection -- randomized; Critical care medicine -- Periodicals; Soins intensifs -- Périodiques; 616.028
• DOI: 10.1097/CCM.0000000000005066
• Languages: English
• ISSNs: 0090-3493

Abstract

Abstract : 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. Abstract : Supplemental Digital Content is available in the text.