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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.ĭesign, 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. Importance Convalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia. Shared Decision Making and CommunicationĬONFLICT OF INTEREST: In the Original Investigation, “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,” published in JAMA Network Open on November 19, 2021, the authors omitted the following disclosures: Dr Menichetti reported serving as LOCAL principal investigator for an AstraZeneca-sponsored trial and a Toscana Life Science-sponsored trial evaluating monoclonal antibodies for SARS-CoV-2 (for which no personal fees were received), and receiving speaker honoraria or advisory board or support for meetings from Angelini, Menarini, Correvio, MSD, Pfizer, Astellas, Gilead, BMS, Jansenn, ViiV, BioMerieux, Biotest, Becton-Dickinson, Pfizer, Shionogi, Roche, GSK, Advanz Pharma, and ThermoFisher, in the last 3 years (outside the submitted work) Dr Bartoloni reported receiving study grants from MSD, ViiV Healthcare, and Nordic Pharma and fees for presentation at local congress or expert meeting from Pfizer and MSD, in the last 3 years (outside the submitted work) Dr Marchetti reported receiving grants for lectures, advisory board, or conferences by Gilead, ViiV, Janssen in the last 3 years (outside the submitted work) Dr d' Arminio Monforte reported receiving grants for lectures, advisory board, or conferences by Gilead, ViiV, MSD, Angelini, and Janssen in the last 3 years (outside the submitted work) Dr Saracino reported receiving grants for research and/or educational purposes from Gilead, ViiV, MSD, Abbvie, Janssen, Shionogi, Pfizer in the last 3 years (outside the submitted work) Dr Castagna reported receiving personal fees from ViiV, MSD, Gilead, Janseen, Theratecnologies in the last 3 years (outside the submitted work) and Dr Falcone reported receiving grants and speaker honoraria from Angelini, Shionogi, MSD, Pfizer, Gilead, Menarini, and Nordic Pharma in the last 3 years (outside the submitted work).įrancesco Menichetti, MD 1 Patrizia Popoli, MD 2 Maria Puopolo, MS 3 et al Stefania Spila Alegiani, MS 2 Giusy Tiseo, MD 1 Alessandro Bartoloni, MD 4 Giuseppe Vittorio De Socio, MD 5 Sauro Luchi, MD 6 Pierluigi Blanc, MD 7 Massimo Puoti, MD 8,9 Elena Toschi, MS 10 Marco Massari, MS 2 Lucia Palmisano, MS 2 Giuseppe Marano, MD 11 Margherita Chiamenti, MD 12 Laura Martinelli, MD 13 Silvia Franchi, MD 13 Carlo Pallotto, MD 14 Lorenzo Roberto Suardi, MD 1,14 Barbara Luciani Pasqua, MD 15 Marco Merli, MD 9 Plinio Fabiani, MD 16 Luca Bertolucci, MD 16 Beatrice Borchi, MD 4 Sara Modica, MD 4 Sara Moneta, MD 6 Giulia Marchetti, MD 17 Antonella d’Arminio Monforte, MD 17 Laura Stoppini, MD 18 Nadia Ferracchiato, MD 18 Stefania Piconi, MD 19 Claudio Fabbri, MD 20 Enrico Beccastrini, MD 21 Riccardo Saccardi, MD 21 Andrea Giacometti, MD 22 Sara Esperti, MD 7 Piera Pierotti, MD 7 Laura Bernini, MD 23 Claudia Bianco, MD 23 Sara Benedetti, MD 5 Alessandra Lanzi, MD 5 Paolo Bonfanti, MD 24 Marco Massari, MD 25 Spartaco Sani, MD 26 Annalisa Saracino, MD 27 Antonella Castagna, MD 28 Luigia Trabace, PhD 29 Maria Lanza, MD 30 Daniele Focosi, MD 30 Alessandro Mazzoni, MD 31 Mauro Pistello, MD 32 Marco Falcone, MD 1 for the TSUNAMI Study group.
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