Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York
RCT 74 hospitalized patients in the USA, showing no significant difference with convalescent plasma treatment.
risk of death, 18.6% lower, RR 0.81, p = 0.75, treatment 16 of 59 (27.1%), control 5 of 15 (33.3%), NNT 16, day 90.
risk of death, 11.0% lower, RR 0.89, p = 1.00, treatment 14 of 59 (23.7%), control 4 of 15 (26.7%), NNT 34, day 28.
risk of no improvement, 0.4% lower, RR 1.00, p = 1.00, treatment 47 of 59 (79.7%), control 12 of 15 (80.0%), NNT 295.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bennett-Guerrero et al., 16 Apr 2021, Double Blind Randomized Controlled Trial, USA, peer-reviewed, 18 authors, trial NCT04344535 (history)
Abstract: FEATURE ARTICLES
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*
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.
KEY WORDS: convalescent plasma; coronavirus disease 2019; infection;
Critical Care Medicine
Elliott Bennett-Guerrero, MD1
Jamie L. Romeiser, PhD1
Lillian R. Talbot, BS2
Tahmeena Ahmed, MD3
Linda J. Mamone, MD3
Sunitha M. Singh, MD4
Janet C. Hearing, PhD5
Huda Salman, MD, PHD6
Dishaw D. Holiprosad, BS7
Alex T. Freedenberg, BS7
Jason A. Carter, PhD2
Nicholas J. Browne, BS7
Megan E. Cosgrove, PhD7
Margaret E. Shevik, BS2
Laura M. Generale, BS7
Margaret A. Andrew, BSN8
Sharon Nachman, MD9
Bettina C. Fries, MD10
for the Stony Brook Medicine
COVID Plasma Trial Group
*See also p. 1182.
Copyright © 2021 by the Society of
Critical Care Medicine and Wolters
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