Transfusion Evidence Alert and Round-Up

On this page you can view articles from previous editions of the Transfusion Evidence Alert and Round-Up. You can also use the button on the left to sign up to receive future editions direct to your inbox.

The Transfusion Evidence Alert is a monthly overview of the top ten evidence-based publications in the field of transfusion medicine. The articles are selected for quality and relevance by clinical experts, supported by members of the Systematic Review Initiative.

The Transfusion Evidence Round-Up is a quarterly overview of the top 10 high quality studies about an internationally relevant subject in the field of transfusion medicine. The articles are selected by members from the International Society of Blood Transfusion and drawn from the Transfusion Evidence Library and, where relevant, Stem Cell Evidence.

Register here to receive the free monthly Transfusion Evidence Alert and the quarterly Round-Up direct to your email account each month.
Subscribe
Editor's Choice

Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial

JAMA Netw Open. 2021 Nov 1;4(11):e2136246 doi: 10.1001/jamanetworkopen.2021.36246.
PICO Summary
POPULATION:

Patients with COVID-19 pneumonia (n= 487).

INTERVENTION:

Convalescent plasma (CP) plus standard therapy (ST), (n= 241).

COMPARISON:

Standard therapy (n= 246).

OUTCOME:

The primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio <150 mm Hg) or death within 30 days from randomization. The primary end point occurred in 59 of 231 patients (25.5%) treated with CP and ST and in 67 of 239 patients (28.0%) who received ST. Adverse events occurred more frequently in the CP group (12 of 241 (5.0%)) compared with the control group (4 of 246 (1.6%)).

Abstract
IMPORTANCE:

Convalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia.

OBJECTIVE:

To evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia.

DESIGN, SETTING, AND PARTICIPANTS:

This prospective, open-label, randomized clinical trial enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen-to-fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg were eligible.

INTERVENTIONS:

Patients in the experimental group received intravenous high-titer CP (≥1:160, by microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids, and low-molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations.

MAIN OUTCOMES AND MEASURES:

The primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio <150 mm Hg) or death within 30 days from randomization.

RESULTS:

Of the 487 randomized patients (241 to CP plus ST; 246 to ST alone), 312 (64.1%) were men; the median (IQR) age was 64 (54.0-74.0) years. The modified intention-to-treat population included 473 patients. The primary end point occurred in 59 of 231 patients (25.5%) treated with CP and ST and in 67 of 239 patients (28.0%) who received ST (odds ratio, 0.88; 95% CI, 0.59-1.33; P = .54). Adverse events occurred more frequently in the CP group (12 of 241 [5.0%]) compared with the control group (4 of 246 [1.6%]; P = .04).

CONCLUSIONS AND RELEVANCE:

In patients with moderate to severe COVID-19 pneumonia, high-titer anti-SARS-CoV-2 CP did not reduce the progression to severe respiratory failure or death within 30 days.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04716556.

Metadata
MESH HEADINGS: Aged; COVID-19; Disease Progression; Female; Hospital Mortality; Hospitalization; Humans; Immunization, Passive; Italy; Male; Middle Aged; Plasma; Prospective Studies; Respiratory Insufficiency; SARS-CoV-2; Severity of Illness Index; Standard of Care; COVID-19 Serotherapy
Study Details
Study Design: Randomised Controlled Trial
Language: eng
Credits: Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine