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- Title
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.
- Authors
Menichetti, Francesco; Popoli, Patrizia; Puopolo, Maria; Spila Alegiani, Stefania; Tiseo, Giusy; Bartoloni, Alessandro; De Socio, Giuseppe Vittorio; Luchi, Sauro; Blanc, Pierluigi; Puoti, Massimo; Toschi, Elena; Massari, Marco; Palmisano, Lucia; Marano, Giuseppe; Chiamenti, Margherita; Martinelli, Laura; Franchi, Silvia; Pallotto, Carlo; Suardi, Lorenzo Roberto; Luciani Pasqua, Barbara
- Abstract
Key Points: Question: Is convalescent plasma useful in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia? Findings: In this randomized clinical trial of 487 patients with COVID-19 pneumonia and a partial pressure of arterial oxygen–to–fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg at enrollment, the rate of the primary clinical end point (need for mechanical ventilation, defined as Pao2/Fio2 ratio <150 mm Hg, or death) was not significantly different between the convalescent plasma group and the control group. Meaning: In this trial, convalescent plasma did not reduce the progression to severe respiratory failure or death within 30 days. This randomized clinical trial evaluates the efficacy of convalescent plasma plus standard therapy vs standard care alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia. 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
- Subjects
ITALY; DISEASE progression; VIRAL pneumonia; RESEARCH; GLUCOCORTICOIDS; ENOXAPARIN; RESPIRATORY insufficiency; COVID-19; CONFIDENCE intervals; DEXAMETHASONE; MEDICAL cooperation; ANTIVIRAL agents; MANN Whitney U Test; SEVERITY of illness index; TREATMENT effectiveness; RANDOMIZED controlled trials; PRE-tests &; post-tests; COMPARATIVE studies; CONVALESCENT plasma; HOSPITAL care; CHI-squared test; KAPLAN-Meier estimator; RESEARCH funding; STATISTICAL sampling; ODDS ratio; DATA analysis software; LONGITUDINAL method
- Publication
JAMA Network Open, 2021, Vol 4, Issue 11, pe2136246
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2021.36246