COVID-19 Evidence Alerts
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Current best evidence for clinical care (more info)

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Treatment Bennett-Guerrero E, Romeiser JL, Talbot LR, et al. 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. Crit Care Med. 2021 Apr 16. pii: 00003246-900000000-95264. doi: 10.1097/CCM.0000000000005066.
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.

Ratings
Discipline / Specialty Area Score
Respirology/Pulmonology
Intensivist/Critical Care
Hospital Doctor/Hospitalists
Internal Medicine
Comments from MORE raters

Hospital Doctor/Hospitalists rater

Another study, this time it is a pragmatic, randomized controlled trial, confirming lack of efficacy of convalescent plasma in COVID-19 hospitalized patients.

Respirology/Pulmonology rater

There is a small sample size. But why do monoclonal antibodies against SARS-CoV 2 seems to be useful?

Respirology/Pulmonology rater

This study is interesting because it is double-blind, and it did not find clinical benefit of Convalescent Plasma compared to Standard Plasma in Coronavirus Disease 2019. These results are relevant in our clinical practice because they provide evidence against the therapy with Convalescent Plasma in hospitalized patients with COVID-19.

Respirology/Pulmonology rater

This is another nail in the coffin of convalescent plasma use. We must remember that convalescent plasma was used a lot in the pre-antibiotic era and its use abandoned because it was so cumbersome.