TY - JOUR
T1 - Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients with COVID-19 Pneumonia
T2 - A Randomized Clinical Trial
AU - Menichetti, Francesco
AU - Popoli, Patrizia
AU - Puopolo, Maria
AU - Spila Alegiani, Stefania
AU - Tiseo, Giusy
AU - Bartoloni, Alessandro
AU - De Socio, Giuseppe Vittorio
AU - Luchi, Sauro
AU - Blanc, Pierluigi
AU - Puoti, Massimo
AU - Toschi, Elena
AU - Massari, Marco
AU - Palmisano, Lucia
AU - Marano, Giuseppe
AU - Chiamenti, Margherita
AU - Martinelli, Laura
AU - Franchi, Silvia
AU - Pallotto, Carlo
AU - Suardi, Lorenzo Roberto
AU - Luciani Pasqua, Barbara
AU - Merli, Marco
AU - Fabiani, Plinio
AU - Bertolucci, Luca
AU - Borchi, Beatrice
AU - Modica, Sara
AU - Moneta, Sara
AU - Marchetti, Giulia
AU - D'Arminio Monforte, Antonella
AU - Stoppini, Laura
AU - Ferracchiato, Nadia
AU - Piconi, Stefania
AU - Fabbri, Claudio
AU - Beccastrini, Enrico
AU - Saccardi, Riccardo
AU - Giacometti, Andrea
AU - Esperti, Sara
AU - Pierotti, Piera
AU - Bernini, Laura
AU - Bianco, Claudia
AU - Benedetti, Sara
AU - Lanzi, Alessandra
AU - Bonfanti, Paolo
AU - Massari, Marco
AU - Sani, Spartaco
AU - Saracino, Annalisa
AU - Castagna, Antonella
AU - Trabace, Luigia
AU - Lanza, Maria
AU - Focosi, Daniele
AU - Falcone, Marco
N1 - Publisher Copyright:
© 2021 American Medical Association. All rights reserved.
PY - 2021
Y1 - 2021
N2 - 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/Fio2ratio <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.
AB - 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/Fio2ratio <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.
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U2 - 10.1001/jamanetworkopen.2021.36246
DO - 10.1001/jamanetworkopen.2021.36246
M3 - Article
AN - SCOPUS:85120326300
SN - 2574-3805
JO - JAMA network open
JF - JAMA network open
M1 - e2136246
ER -