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 network open

F Menichetti; P Popoli; M Puopolo; S Spila Alegiani; G Tiseo; A Bartoloni; GV De Socio; S Luchi; P Blanc; M Puoti; E Toschi; M Massari; L Palmisano; G Marano; M Chiamenti; L Martinelli; S Franchi; C Pallotto; LR Suardi; B Luciani Pasqua; M Merli; P Fabiani; L Bertolucci; B Borchi; S Modica; S Moneta; G Marchetti; A d'Arminio Monforte; L Stoppini; N Ferracchiato; S Piconi; C Fabbri; E Beccastrini; R Saccardi; A Giacometti; S Esperti; P Pierotti; L Bernini; C Bianco; S Benedetti; A Lanzi; P Bonfanti; S Sani; A Saracino; A Castagna; L Trabace; M Lanza; D Focosi; A Mazzoni; M Pistello; M Falcone; for the TSUNAMI Study group

doi:10.1001/jamanetworkopen.2021.36246

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 network open

F Menichetti, P Popoli, M Puopolo, S Spila Alegiani, G Tiseo, A Bartoloni, GV De Socio, S Luchi, P Blanc, M Puoti, E Toschi, M Massari, L Palmisano, G Marano, M Chiamenti, L Martinelli, S Franchi, C Pallotto, LR Suardi, B Luciani PasquaM Merli, P Fabiani, L Bertolucci, B Borchi, S Modica, S Moneta, G Marchetti, A d'Arminio Monforte, L Stoppini, N Ferracchiato, S Piconi, C Fabbri, E Beccastrini, R Saccardi, A Giacometti, S Esperti, P Pierotti, L Bernini, C Bianco, S Benedetti, A Lanzi, P Bonfanti, S Sani, A Saracino, A Castagna, L Trabace, M Lanza, D Focosi, A Mazzoni, M Pistello, M Falcone, for the TSUNAMI Study group

Research output: Contribution to journal › Article › peer-review

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

Original language	English
Article number	e2136246
Journal	JAMA Netw. Open
Volume	4
Issue number	11
DOIs	https://doi.org/10.1001/jamanetworkopen.2021.36246
Publication status	Published - 2021

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Menichetti, F., Popoli, P., Puopolo, M., Spila Alegiani, S., Tiseo, G., Bartoloni, A., De Socio, GV., Luchi, S., Blanc, P., Puoti, M., Toschi, E., Massari, M., Palmisano, L., Marano, G., Chiamenti, M., Martinelli, L., Franchi, S., Pallotto, C., Suardi, LR., ... group, F. T. TSUNAMI. S. (2021). 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 network open. JAMA Netw. Open, 4(11), [e2136246]. https://doi.org/10.1001/jamanetworkopen.2021.36246

Menichetti, F, Popoli, P , Puopolo, M , Spila Alegiani, S, Tiseo, G, Bartoloni, A, De Socio, GV, Luchi, S, Blanc, P, Puoti, M, Toschi, E , Massari, M , Palmisano, L, Marano, G, Chiamenti, M, Martinelli, L, Franchi, S, Pallotto, C, Suardi, LR, Luciani Pasqua, B, Merli, M, Fabiani, P, Bertolucci, L, Borchi, B, Modica, S, Moneta, S, Marchetti, G, d'Arminio Monforte, A, Stoppini, L, Ferracchiato, N, Piconi, S, Fabbri, C, Beccastrini, E, Saccardi, R, Giacometti, A, Esperti, S, Pierotti, P, Bernini, L, Bianco, C , Benedetti, S, Lanzi, A, Bonfanti, P, Sani, S, Saracino, A, Castagna, A, Trabace, L, Lanza, M, Focosi, D, Mazzoni, A, Pistello, M, Falcone, M & group, FTTSUNAMIS 2021, '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 network open', JAMA Netw. Open, vol. 4, no. 11, e2136246. https://doi.org/10.1001/jamanetworkopen.2021.36246

@article{88dbac017064453e9e32abb109752b3b,

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: JAMA network open",

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 ",

author = "F Menichetti and P Popoli and M Puopolo and {Spila Alegiani}, S and G Tiseo and A Bartoloni and {De Socio}, GV and S Luchi and P Blanc and M Puoti and E Toschi and M Massari and L Palmisano and G Marano and M Chiamenti and L Martinelli and S Franchi and C Pallotto and LR Suardi and {Luciani Pasqua}, B and M Merli and P Fabiani and L Bertolucci and B Borchi and S Modica and S Moneta and G Marchetti and {d'Arminio Monforte}, A and L Stoppini and N Ferracchiato and S Piconi and C Fabbri and E Beccastrini and R Saccardi and A Giacometti and S Esperti and P Pierotti and L Bernini and C Bianco and S Benedetti and A Lanzi and P Bonfanti and S Sani and A Saracino and A Castagna and L Trabace and M Lanza and D Focosi and A Mazzoni and M Pistello and M Falcone and group, {for the TSUNAMI Study}",

year = "2021",

doi = "10.1001/jamanetworkopen.2021.36246",

language = "English",

volume = "4",

journal = "JAMA Netw. Open",

issn = "2574-3805",

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T1 - 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

T2 - JAMA network open

AU - Menichetti, F

AU - Popoli, P

AU - Puopolo, M

AU - Spila Alegiani, S

AU - Tiseo, G

AU - Bartoloni, A

AU - De Socio, GV

AU - Luchi, S

AU - Blanc, P

AU - Puoti, M

AU - Toschi, E

AU - Massari, M

AU - Palmisano, L

AU - Marano, G

AU - Chiamenti, M

AU - Martinelli, L

AU - Franchi, S

AU - Pallotto, C

AU - Suardi, LR

AU - Luciani Pasqua, B

AU - Merli, M

AU - Fabiani, P

AU - Bertolucci, L

AU - Borchi, B

AU - Modica, S

AU - Moneta, S

AU - Marchetti, G

AU - d'Arminio Monforte, A

AU - Stoppini, L

AU - Ferracchiato, N

AU - Piconi, S

AU - Fabbri, C

AU - Beccastrini, E

AU - Saccardi, R

AU - Giacometti, A

AU - Esperti, S

AU - Pierotti, P

AU - Bernini, L

AU - Bianco, C

AU - Benedetti, S

AU - Lanzi, A

AU - Bonfanti, P

AU - Sani, S

AU - Saracino, A

AU - Castagna, A

AU - Trabace, L

AU - Lanza, M

AU - Focosi, D

AU - Mazzoni, A

AU - Pistello, M

AU - Falcone, M

AU - group, for the TSUNAMI Study

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/Fio2 ratio

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/Fio2 ratio

U2 - 10.1001/jamanetworkopen.2021.36246

DO - 10.1001/jamanetworkopen.2021.36246

M3 - Article

SN - 2574-3805

VL - 4

JO - JAMA Netw. Open

JF - JAMA Netw. Open

IS - 11

M1 - e2136246

ER -

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 network open

Abstract

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