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1. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries

Author

Russotto V., Myatra S. N., Laffey J. G., Tassistro E., Antolini L., Bauer P., Lascarrou J. B., Szuldrzynski K., Camporota L., Pelosi P., Sorbello M., Higgs A., Greif R., Putensen C., Agvald-Ohman C., Chalkias A., Bokums K., Brewster D., Rossi E., Fumagalli R., Pesenti A., Foti G., Bellani G., Hazem Abdelkarem Ahmed, Neill K J Adhikari, Kehari Agrawal, Nipun Agrawal, Hernan Aguirre-Bermeo, Christina Agvald-Öhman, Meraj Ahmad, Samareh Ajami, Shazia N Akhtar, Adnan Alghamdi, Abdulmueti Alhadi, Syed M Ali, Mohd N Ali, Anita Alias, Ghaleb Almekhlafi, Julio Alonso, Diana Alvarez Montenegro, Rubina Aman, Matthew Anstey, Irene Aragão, Eleni Arnaoutoglou, Elie Azoulay, Laura Baccari, Nishanth Baliga, Ramya Ballekatte Manjunath, Shrirang Bamane, Anna Bandert, Roland Bartholdy, Marta Basto, Vera Baturova, Philippe R Bauer, Agrippino Bellissima, Vladislav Belsky, Prashant Bendre, Annalisa Benini, Sebastien Besset, Mahuya Bhattacharyya, Piotr Bielanski, Luca Bigatello, Florence Boissier, Kristaps Bokums, Elisa Boni, Iwona Bonney, David Bowen, Alexandre Boyer, Luca Brazzi, David Brewster, Lina Broman, Alexander Browne, Cedric Bruel, Yannick Brunin, Guillermo Bugedo, Italo Calamai, Patricia Campos, Federico G Canavosio, Iacopo Cappellini, Marco Cascella, Nuno Catorze, Athanasios Chalkias, Benoit Champigneulle, Juhi Chandwani, Anne Chao, Satish Chaurasia, Rajesh Chawla, Aakanksha Chawla, Olivia Cheetham, Frank Chemouni, Lee Chew Kiok, Jung-Yien Chien, Timothy Chimunda, Ching-Tang Chiu, Fernando Chiumiento, Nai-Kuan Chou, Nicolas Chudeau, Sandra Colica, Gwenhael Colin, Jean-Michel Constantin, Damien Contou, Andrea Cortegiani, Paulo F Costa, Vasco Costa, Andrea Costamagna, Antonella Cotoia, Andrea N Cracchiolo, Petra Crone, Rui P Cunha, Renata Curić Radivojević, Amit Das, Sampat Dash, Gennaro De Pascale, Silvia De Rosa, Lorenzo Del Sorbo, Valentina Della Torre, Barbara Di Caprio, Raffaele Di Fenza, Ida Di Giacinto, Aikaterini Dimitropoulou, Marcel Dudda, Christopher Edmunds, Stefan F Ehrentraut, Nadia El-Fellah, Muhammed Elhadi, Ahmed Elhadi, Patricia Escudero-Acha, Missael Espinoza, Clelia Esposito, Fabrizio Fabretti, Daniel G Fein, Massimo Ferluga, Marco Fernandes, Alexis Ferre, Janet Ferrier, Marek Flaksa, Fernando Flores, Jesus Flores Gonzalez, Xavier E Fonseca Fuentes, Roland Francis, Daniela G Franco, Pawel Franczyk, Jean-Pierre Frat, Mikhail Furman, Maurizio Fusari, Piotr Galkin, Alice Gallo de Moraes, Renato Gammaldi, Maria F García Aguilera, Eugenio Garofalo, Tomasz Gaszynski, Jonathan Gatward, Mohamed Ghula, Angelo Giacomucci, Ilaria Giovannini, Kingsly Gnanadurai, Thomas Godet, Alberto Goffi, Gemma Goma Fernandez, Maria Gonzalez, Daira González, Alejandro González-Castro, Kadarapura N Gopalakrishna, Eric Gottesman, Alexandre Gros, Christophe Guervilly, Christophe Guitton, Manish Gupta, Kulbhusahn Gupta, Tarikul Hamid, Olfa Hamzaoui, Katrin Hannesdottir, Shahnaz Hasan, Mozaffer Hossain, Sazzad Hossein, Sami Hraiech, Chun-Kai Huang, Cameron Hypes, Soad Imhmed Alkhumsi, Motiul Islam, Muhamad A Ismail, Višnja Ivančan, Sophie Jacquier, Bharat Jagiasi, Nikhilesh Jain, Muhamad Fadhil Hadi Jamaluddin, Milosz Jankowski, Deepak Jeswani, Deepti Jeswani, Simant Jha, Laura Jones, Benjamin Jones, Mathieu Jozwiak, Aleksandra Jumić, Oliver Kamp, Ilias Karametos, Alexey Karelov, Panagiotis Katsoulis, David A Kaufman, Shuchi Kaushik, Callum T Kaye, Subba R Kesavarapu, Ala Khaled, Hapiz Khalidah, Akram Khan, Sudhir Khunteta, Detlef Kindgen-Milles, Sara V Korula, Amol Kothekar, Salman S Koul, Ditte Krog, Shih-Chi Ku, Mira Kuellmar, Lu-Cheng Kuo, Swarna D Kuragayala, Aikaterini Kyparissi, Gonzalo Labarca, John G Laffey, Jaya Lalwani, Antonio Landaverde, Jean-Baptiste Lascarrou, Andres Laserna, Chien-Chang Lee, Stephane Legriel, Andrew Lehr, Tiago Leonor, Yongxing Li, Anna Lisa Licciardi, Edward Litton, Vladimir Lomivorotov, Federico Longhini, Claudia L Lopez Nava, Luis R Loza Gallardo, Ramona Lungu, Annalisa Luzi, Wuhua Ma, Marat Magomedov, Alexandros Makris, Harish Mallapura Maheshwarappa, Tommaso Maraffi, Maria E Marcelli, Karim Mariano, Nathalie Marin, Nadezhda Marova, Maelle Martin, Mayra Martinez Gonzalez, Emilio Maseda, Fiore Mastroianni, Marijana Matas, Dubier Matos, Jessica G Maugeri, Mohd Z Mazlan, Melanie Meersch, Ranjan Meher, Tasneem H Mehesry, Maria Meirik, Armand Mekontso Dessap, Kwabena Mensah, Emmanuelle Mercier, Pavel Michalek, Abhirup Midya, Slobodan Mihaljević, Adrien Mirouse, Prasanna Mishra, Ravi Mistry, Mate Moguš, Norbaniza Mohd Nordin, Noryani Mohd Samat, Luca Montini, Giorgia Montrucchio, Valeria Moro, Diego Morocho Tutillo, Jarrod Mosier, Sircar Mrinal, Wojciech Mudyna, Grégoire Muller, Kartik Munta, Satheesh Munusamy, Stefania Musso, Stefano Muttini, Ismail Nahla Irtiza, Evi Nakou, Amit Narkhede, Joseph Nates, Moana R Nespoli, Francesca Nespoli, Artem Nikitenko, Carla Nogueira, Ross O'Grady, Yewande E Odeyemi, Annika Ohlsson, Alberto Orsello, Vijayanand Palaniswamy, Daniela M Palma, Salvatore Palmese, Jesus N Pantoja Leal, Eleni Papandreou, Metaxia Papanikolaou, Matteo Parotto, Mayur Patel, Mario Pavlek, Niccolò Pedrotti, Ngu Pei Hwa, Lorella Pelagalli, Miryam Pérez Ruiz, Elin Persson, Athanasia Petsiou, Angelo Pezzi, Sam Philip, Francois Philippard, Mariusz Piegat, Sébastien Pili-Floury, Riccardo Pinciroli, Marcia Pinto, Gael Piton, Gaetan Plantefeve, Caroline Pouplet, Sofia Pouriki, Andrea Pradella, Kumar Prashant, Christian Putensen, Alice Quayle, Lua Rahmani, Ian Randall, Banambar Ray, Adrian Regli, Syed T Reza, Jean Damien Ricard, Ivano Riva, Oriol Roca, Roberto Rona, Jon Rosell, Rebecca Rowley, Sheng-Yuan Ruan, Kay Rumschuessel, Annalisa Rundo, Pierpaolo Russo, Vincenzo Russotto, Samir Sahu, Gabriele Sales, Charlotte Salmon-Gandonnière, Nandyelly San Juan Roman, Luis Sánchez-Hurtado, Benjamin J Sandefur, Manel Santafe, Lida Santoro, Rhik Sanyal, Lakshmikanthcharan Saravanabavan, Bhagyesh Shah, Mehul Shah, Ming-Hann Shin, Monica Silva, Shannon Simpson, Ayush Sinah, Atul K Singh, Dinesh K Singh, Nitesh Singh, Lalit Singh, Lukasz Skowronski, Miguel A Sosa, Savino Spadaro, Martin Spangfors, Jesper Sperber, Rosario Spina, Anand Srivastava, Andrew Steel, Alejandro Suarez de la Rica, Singh Sujeet Kumar, Omprakash Sundrani, Nilu Sunil, Bharadwaj Suparna, Manimala R Surath, Yadullah Syed, Tamas Szakmany, Benjamin Sztrymf, Alexis Tabah, Stefano Tarantino, Maria Tileli, Hugo Tirape-Castro, Otoniel Toledo-Salinas, Jacopo Tramarin, Dimitrios Tsiftsis, Iva Tucić, Jose A Tutillo León, Lorenzo Tutino, Vijay N Tyagi, Kyriaki Vagdatli, Sneha Varkey, Maria M Vera, Magnus Von Seth, Carl Wahlstrom, Wan Mohd N Wan Hassan, Wan N Wan Ismail, Kuo-Chuan Wang, Hadrien Winiszewski, Jiayan Wu, Lun Wu, Yu-Chang Yeh, Paul Young, Gianluca Zani, Jonathan Zarka, Dawn Zhao, Diane Zlotnik, Russotto, V, Myatra, S, Laffey, J, Tassistro, E, Antolini, L, Bauer, P, Lascarrou, J, Szuldrzynski, K, Camporota, L, Pelosi, P, Sorbello, M, Higgs, A, Greif, R, Putensen, C, Agvald-Öhman, C, Chalkias, A, Bokums, K, Brewster, D, Rossi, E, Fumagalli, R, Pesenti, A, Foti, G, Bellani, G, Russotto V., Myatra S.N., Laffey J.G., Tassistro E., Antolini L., Bauer P., Lascarrou J.B., Szuldrzynski K., Camporota L., Pelosi P., Sorbello M., Higgs A., Greif R., Putensen C., Agvald-Ohman C., Chalkias A., Bokums K., Brewster D., Rossi E., Fumagalli R., Pesenti A., Foti G., Bellani G., and Hazem Abdelkarem Ahmed, Neill K J Adhikari, Kehari Agrawal, Nipun Agrawal, Hernan Aguirre-Bermeo, Christina Agvald-Öhman, Meraj Ahmad, Samareh Ajami, Shazia N Akhtar, Adnan Alghamdi, Abdulmueti Alhadi, Syed M Ali, Mohd N Ali, Anita Alias, Ghaleb Almekhlafi, Julio Alonso, Diana Alvarez Montenegro, Rubina Aman, Matthew Anstey, Irene Aragão, Eleni Arnaoutoglou, Elie Azoulay, Laura Baccari, Nishanth Baliga, Ramya Ballekatte Manjunath, Shrirang Bamane, Anna Bandert, Roland Bartholdy, Marta Basto, Vera Baturova, Philippe R Bauer, Agrippino Bellissima, Vladislav Belsky, Prashant Bendre, Annalisa Benini, Sebastien Besset, Mahuya Bhattacharyya, Piotr Bielanski, Luca Bigatello, Florence Boissier, Kristaps Bokums, Elisa Boni, Iwona Bonney, David Bowen, Alexandre Boyer, Luca Brazzi, David Brewster, Lina Broman, Alexander Browne, Cedric Bruel, Yannick Brunin, Guillermo Bugedo, Italo Calamai, Patricia Campos, Federico G Canavosio, Iacopo Cappellini, Marco Cascella, Nuno Catorze, Athanasios Chalkias, Benoit Champigneulle, Juhi Chandwani, Anne Chao, Satish Chaurasia, Rajesh Chawla, Aakanksha Chawla, Olivia Cheetham, Frank Chemouni, Lee Chew Kiok, Jung-Yien Chien, Timothy Chimunda, Ching-Tang Chiu, Fernando Chiumiento, Nai-Kuan Chou, Nicolas Chudeau, Sandra Colica, Gwenhael Colin, Jean-Michel Constantin, Damien Contou, Andrea Cortegiani, Paulo F Costa, Vasco Costa, Andrea Costamagna, Antonella Cotoia, Andrea N Cracchiolo, Petra Crone, Rui P Cunha, Renata Curić Radivojević, Amit Das, Sampat Dash, Gennaro De Pascale, Silvia De Rosa, Lorenzo Del Sorbo, Valentina Della Torre, Barbara Di Caprio, Raffaele Di Fenza, Ida Di Giacinto, Aikaterini Dimitropoulou, Marcel Dudda, Christopher Edmunds, Stefan F Ehrentraut, Nadia El-Fellah, Muhammed Elhadi, Ahmed Elhadi, Patricia Escudero-Acha, Missael Espinoza, Clelia Esposito, Fabrizio Fabretti, Daniel G Fein, Massimo Ferluga, Marco Fernandes, Alexis Ferre, Janet Ferrier, Marek Flaksa, Fernando Flores, Jesus Flores Gonzalez, Xavier E Fonseca Fuentes, Roland Francis, Daniela G Franco, Pawel Franczyk, Jean-Pierre Frat, Mikhail Furman, Maurizio Fusari, Piotr Galkin, Alice Gallo de Moraes, Renato Gammaldi, Maria F García Aguilera, Eugenio Garofalo, Tomasz Gaszynski, Jonathan Gatward, Mohamed Ghula, Angelo Giacomucci, Ilaria Giovannini, Kingsly Gnanadurai, Thomas Godet, Alberto Goffi, Gemma Goma Fernandez, Maria Gonzalez, Daira González, Alejandro González-Castro, Kadarapura N Gopalakrishna, Eric Gottesman, Alexandre Gros, Christophe Guervilly, Christophe Guitton, Manish Gupta, Kulbhusahn Gupta, Tarikul Hamid, Olfa Hamzaoui, Katrin Hannesdottir, Shahnaz Hasan, Mozaffer Hossain, Sazzad Hossein, Sami Hraiech, Chun-Kai Huang, Cameron Hypes, Soad Imhmed Alkhumsi, Motiul Islam, Muhamad A Ismail, Višnja Ivančan, Sophie Jacquier, Bharat Jagiasi, Nikhilesh Jain, Muhamad Fadhil Hadi Jamaluddin, Milosz Jankowski, Deepak Jeswani, Deepti Jeswani, Simant Jha, Laura Jones, Benjamin Jones, Mathieu Jozwiak, Aleksandra Jumić, Oliver Kamp, Ilias Karametos, Alexey Karelov, Panagiotis Katsoulis, David A Kaufman, Shuchi Kaushik, Callum T Kaye, Subba R Kesavarapu, Ala Khaled, Hapiz Khalidah, Akram Khan, Sudhir Khunteta, Detlef Kindgen-Milles, Sara V Korula, Amol Kothekar, Salman S Koul, Ditte Krog, Shih-Chi Ku, Mira Kuellmar, Lu-Cheng Kuo, Swarna D Kuragayala, Aikaterini Kyparissi, Gonzalo Labarca, John G Laffey, Jaya Lalwani, Antonio Landaverde, Jean-Baptiste Lascarrou, Andres Laserna, Chien-Chang Lee, Stephane Legriel, Andrew Lehr, Tiago Leonor, Yongxing Li, Anna Lisa Licciardi, Edward Litton, Vladimir Lomivorotov, Federico Longhini, Claudia L Lopez Nava, Luis R Loza Gallardo, Ramona Lungu, Annalisa Luzi, Wuhua Ma, Marat Magomedov, Alexandros Makris, Harish Mallapura Maheshwarappa, Tommaso Maraffi, Maria E Marcelli, Karim Mariano, Nathalie Marin, Nadezhda Marova, Maelle Martin, Mayra Martinez Gonzalez, Emilio Maseda, Fiore Mastroianni, Marijana Matas, Dubier Matos, Jessica G Maugeri, Mohd Z Mazlan, Melanie Meersch, Ranjan Meher, Tasneem H Mehesry, Maria Meirik, Armand Mekontso Dessap, Kwabena Mensah, Emmanuelle Mercier, Pavel Michalek, Abhirup Midya, Slobodan Mihaljević, Adrien Mirouse, Prasanna Mishra, Ravi Mistry, Mate Moguš, Norbaniza Mohd Nordin, Noryani Mohd Samat, Luca Montini, Giorgia Montrucchio, Valeria Moro, Diego Morocho Tutillo, Jarrod Mosier, Sircar Mrinal, Wojciech Mudyna, Grégoire Muller, Kartik Munta, Satheesh Munusamy, Stefania Musso, Stefano Muttini, Ismail Nahla Irtiza, Evi Nakou, Amit Narkhede, Joseph Nates, Moana R Nespoli, Francesca Nespoli, Artem Nikitenko, Carla Nogueira, Ross O'Grady, Yewande E Odeyemi, Annika Ohlsson, Alberto Orsello, Vijayanand Palaniswamy, Daniela M Palma, Salvatore Palmese, Jesus N Pantoja Leal, Eleni Papandreou, Metaxia Papanikolaou, Matteo Parotto, Mayur Patel, Mario Pavlek, Niccolò Pedrotti, Ngu Pei Hwa, Lorella Pelagalli, Miryam Pérez Ruiz, Elin Persson, Athanasia Petsiou, Angelo Pezzi, Sam Philip, Francois Philippard, Mariusz Piegat, Sébastien Pili-Floury, Riccardo Pinciroli, Marcia Pinto, Gael Piton, Gaetan Plantefeve, Caroline Pouplet, Sofia Pouriki, Andrea Pradella, Kumar Prashant, Christian Putensen, Alice Quayle, Lua Rahmani, Ian Randall, Banambar Ray, Adrian Regli, Syed T Reza, Jean Damien Ricard, Ivano Riva, Oriol Roca, Roberto Rona, Jon Rosell, Rebecca Rowley, Sheng-Yuan Ruan, Kay Rumschuessel, Annalisa Rundo, Pierpaolo Russo, Vincenzo Russotto, Samir Sahu, Gabriele Sales, Charlotte Salmon-Gandonnière, Nandyelly San Juan Roman, Luis Sánchez-Hurtado, Benjamin J Sandefur, Manel Santafe, Lida Santoro, Rhik Sanyal, Lakshmikanthcharan Saravanabavan, Bhagyesh Shah, Mehul Shah, Ming-Hann Shin, Monica Silva, Shannon Simpson, Ayush Sinah, Atul K Singh, Dinesh K Singh, Nitesh Singh, Lalit Singh, Lukasz Skowronski, Miguel A Sosa, Savino Spadaro, Martin Spangfors, Jesper Sperber, Rosario Spina, Anand Srivastava, Andrew Steel, Alejandro Suarez de la Rica, Singh Sujeet Kumar, Omprakash Sundrani, Nilu Sunil, Bharadwaj Suparna, Manimala R Surath, Yadullah Syed, Tamas Szakmany, Benjamin Sztrymf, Alexis Tabah, Stefano Tarantino, Maria Tileli, Hugo Tirape-Castro, Otoniel Toledo-Salinas, Jacopo Tramarin, Dimitrios Tsiftsis, Iva Tucić, Jose A Tutillo León, Lorenzo Tutino, Vijay N Tyagi, Kyriaki Vagdatli, Sneha Varkey, Maria M Vera, Magnus Von Seth, Carl Wahlstrom, Wan Mohd N Wan Hassan, Wan N Wan Ismail, Kuo-Chuan Wang, Hadrien Winiszewski, Jiayan Wu, Lun Wu, Yu-Chang Yeh, Paul Young, Gianluca Zani, Jonathan Zarka, Dawn Zhao, Diane Zlotnik

Subjects
Male, medicine.medical_specialty, Critical Illness, medicine.medical_treatment, Aged, Female, Heart Arrest, Humans, Hypotension, Hypoxia, Intensive Care Units, Intubation, Intratracheal, Logistic Models, Medical Errors, Middle Aged, Prospective Studies, Respiration, Artificial, Respiratory Insufficiency, Vasoconstrictor Agents, 01 natural sciences, NO, tracheal intubation, adverse peri-intubation events, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Intensive care, Settore MED/41 - ANESTESIOLOGIA, Medicine, Intubation, Intubation, Critical Care, 030212 general & internal medicine, 0101 mathematics, 610 Medicine & health, Prospective cohort study, business.industry, Respiration, 010102 general mathematics, Tracheal intubation, General Medicine, Intratracheal, Intubation procedure, Respiratory failure, Artificial, Emergency medicine, Airway management, business
Abstract

Importance: Tracheal intubation is one of the most commonly performed and high-risk interventions in critically ill patients. Limited information is available on adverse peri-intubation events. Objective: To evaluate the incidence and nature of adverse peri-intubation events and to assess current practice of intubation in critically ill patients. Design, Setting, and Participants: The International Observational Study to Understand the Impact and Best Practices of Airway Management in Critically Ill Patients (INTUBE) study was an international, multicenter, prospective cohort study involving consecutive critically ill patients undergoing tracheal intubation in the intensive care units (ICUs), emergency departments, and wards, from October 1, 2018, to July 31, 2019 (August 28, 2019, was the final follow-up) in a convenience sample of 197 sites from 29 countries across 5 continents. Exposures: Tracheal intubation. Main Outcomes and Measures: The primary outcome was the incidence of major adverse peri-intubation events defined as at least 1 of the following events occurring within 30 minutes from the start of the intubation procedure: cardiovascular instability (either: systolic pressure 30 minutes, new or increase need of vasopressors or fluid bolus >15 mL/kg), severe hypoxemia (peripheral oxygen saturation

Published
2021

2. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

François-Xavier Lescure, Hitoshi Honda, Robert A Fowler, Jennifer Sloane Lazar, Genming Shi, Peter Wung, Naimish Patel, Owen Hagino, Ignacio J. Bazzalo, Marcelo M. Casas, Sebastián A. Nuñez, Yael Pere, Carlos M. Ibarrola, Marco A. Solis Aramayo, Maria C. Cuesta, Andrea E. Duarte, Pablo M. Gutierrez Fernandez, Maria A. Iannantuono, Erica A. Miyazaki, Javier P. Silvio, Dario G. Scublinsky, Alessandra Bales, Daniela Catarino, Elie Fiss, Sara Mohrbacher, Victor Sato, Antonio Baylao, Adilson Cavalcante, Francini Correa, Celso A. de Andrade, Juvencio Furtado, Nelson Ribeiro Filho, Valéria Telles, Leopoldo T. Trevelin, Ricardo Vipich, Rodrigo Boldo, Paula Borges, Suzana Lobo, Graziela Luckemeyer, Luana Machado, Maysa B. Alves, Ana C. Iglessias, Marianna M. Lago, Daniel W. Santos, Hugo Chapdelaine, Emilia L. Falcone, Rahima Jamal, Me-Linh Luong, Madeleine Durand, Stephane Doucet, François-Martin Carrier, Bryan A. Coburn, Lorenzo Del Sorbo, Sharon L. Walmsley, Sara Belga, Luke Y. Chen, Allison D. Mah, Theodore Steiner, Alissa J. Wright, J. Hajek, Neill Adhikari, Robert A. Fowler, Nick Daneman, Kosar A. Khwaja, Jason Shahin, Carolina Gonzalez, Rafael Silva, Marcelo Lindh, Gabriel Maluenda, Patricia Fernandez, Maite Oyonarte, Martin Lasso, Alexandre Boyer, Didier Bronnimann, Hoang-Nam Bui, Charles Cazanave, Helene Chaussade, Arnaud Desclaux, Mailys Ducours, Alexandre Duvignaud, Denis Malvy, Lisa Martin, Didier Neau, Duc Nguyen, Thierry Pistone, Gaetane Soubrane-Wirth, Julie Leitao, Clotilde Allavena, Charlotte Biron, Sabelline Bouchez, Benjamin Gaborit, Antoine Gregoire, Paul Le Turnier, Anne-Sophie Lecompte, Raphael Lecomte, Maeva Lefebvre, Francois Raffi, David Boutoille, Pascale H. Morineau, Romain Guéry, Emmanuel Chatelus, Nathalie Dumoussaud, Renaud Felten, Florina Luca, Bernard Goichot, Francis Schneider, Marie-Caroline Taquet, Matthieu Groh, Mathilde Roumier, Mathilde Neuville, Antoine Bachelard, Valentina Isernia, F-Xavier Lescure, Bao-Chau Phung, Anne Rachline, Aurelie Sautereau, Dorothee Vallois, Yves Bleher, Delphine Boucher, Clémentine Coudon, Jean Esnault, Thomas Guimard, Sophie Leautez-Nainville, Dominique Merrien, Marine Morrier, Pauline Motte-Vincent, Romain Gabeff, Hélène Leclerc, Céline Cozic, Romain Decours, Ronan Février, Gwenhael Colin, Sophie Abgrall, Dorothee Vignes, Raluca Sterpu, Mira Kuellmar, Melanie Meersch-Dini, Raphael Weiss, Alexander Zarbock, Christiane Antony, Marc Berger, Thorsten Brenner, Christian Taube, Frank Herbstreit, Sebastian Dolff, Margarethe Konik, Karsten Schmidt, Markus Zettler, Oliver Witzke, Boris Boell, Jorge Garcia Borrega, Philipp Koehler, Thomas Zander, Fabian Dusse, Othman Al-Sawaf, Philipp Köhler, Dennis Eichenauer, Matthias Kochanek, Alexander Shimabukuro-Vornhagen, Sibylle Mellinghoff, Annika Claßen, Jan-Michel Heger, Charlotte Meyer-Schwickerath, Paul Liedgens, Katrin Heindel, Ana Belkin, Asaf Biber, Mayan Gilboa, Itzchak Levy, Vladislav Litachevsky, Galia Rahav, Anat Finesod Wiedner, Tal Zilberman-Daniels, Yonatan Oster, Jacob Strahilevitz, Sigal Sviri, Elena M. Baldissera, Corrado Campochiaro, Giulio Cavalli, Lorenzo Dagna, Giacomo De Luca, Emanuel Della Torre, Alessandro Tomelleri, Davide Bernasconi De Luca, Amedeo F. Capetti, Massimo Coen, Maria V. Cossu, Massimo Galli, Andrea Giacomelli, Guido A. Gubertini, Stefano Rusconi, Giulia J. Burastero, Margherita Digaetano, Giovanni Guaraldi, Marianna Meschiari, Cristina Mussini, Cinzia Puzzolante, Sara Volpi, Marina Aiello, Alarico Ariani, Alfredo A. Chetta, Annalisa Frizzelli, Andrea Ticinesi, Domenico Tuttolomondo, Stefano Aliberti, Francesco B. Blasi, Marta F. Di Pasquale, Sofia Misuraca, Tommaso Pilocane, Edoardo Simonetta, Alessio M. Aghelmo, Claudio Angelini, Enrico Brunetta, Giorgio W. Canonica, Michele Ciccarelli, Sara Dal Farra, Maria De Santis, Sebastian Ferri, Marco Folci, Giacomo M. Guidelli, Enrico M. Heffler, Ferdinando Loiacono, Giacomo Malipiero, Giovanni Paoletti, Rosa Pedale, Francesca A. Puggioni, Francesca Racca, Aurora Zumbo, Morihiko Satou, Tatyana Lisun, Denis Protsenko, Nikolay Rubtsov, Irina Beloglazova, Daria Fomina, Mariana Lysenko, Sofia Serdotetskova, Vitali Firstov, Ivan Gordeev, Ilia Kokorin, Ksenia Komissarova, Nina Lapochkina, Elena Luchinkina, Valentin Malimon, Sevinch Mamedguseyinova, Ksenia Polubatonova, Natalia Suvorova, Jose Arribas, Alberto M. Borobia Perez, Fernando de la Calle Prieto, Juan Carlos Figueira, Rocio Motejano Sanchez, Marta Mora-Rillo, Concepcion Prados Sanchez, Javier Queiruga Parada, Francisco Fernandez Arnalich, Maria Guerro Barrientos, Alejandro Bendala Estrada, Aranzazu Caballero Marcos, Maria E. Garcia Leoni, Rita García-Martínez, Ana María Collado, Patricia Munoz Garcia, Ana Torres do Rego, María V. Villalba García, Almudena Burrillo, Maricela Valerio Minero, Paloma Gijon Vidaurreta, Sonsoles Infante Herrero, Elena Velilla, Marina Machado, Maria Olmedo, Blanca Pinilla, Benito Almirante Gragera, Maria de la Esperanza Cañas Ruano, Sofia Contreras Medina, Alejandro Cortés Herrera, Vicenç Falcó Ferrer, Ricard Ferrer Roca, Xavier Nuvials Casals, Esteve Ribera Pascuet, Paula Suanzes Diez, Pedro Rebollo Castro, Felipe Garcia Alcaide, Alejandro Soriano, Aina Oliver Caldes, Ana González Cordón, Celia Cardozo, Lorena De la Mora Cañizo, Romina Pena López, Sandra Chamorro, Clara Crespillo-Andujar, Rosa Escudero Sanchez, Jesús Fortún-Abete, Begoña Monge-Maillo, Ana Moreno Zamora, Francesca Norman, Matilde Sanchez Conde, Sergio Serrano Villar, Pilar Vizcarra, Lescure, F. -X., Honda, H., Fowler, R. A., Lazar, J. S., Shi, G., Wung, P., Patel, N., Hagino, O., Bazzalo, I. J., Casas, M. M., Nunez, S. A., Pere, Y., Ibarrola, C. M., Solis Aramayo, M. A., Cuesta, M. C., Duarte, A. E., Gutierrez Fernandez, P. M., Iannantuono, M. A., Miyazaki, E. A., Silvio, J. P., Scublinsky, D. G., Bales, A., Catarino, D., Fiss, E., Mohrbacher, S., Sato, V., Baylao, A., Cavalcante, A., Correa, F., de Andrade, C. A., Furtado, J., Ribeiro Filho, N., Telles, V., Trevelin, L. T., Vipich, R., Boldo, R., Borges, P., Lobo, S., Luckemeyer, G., Machado, L., Alves, M. B., Iglessias, A. C., Lago, M. M., Santos, D. W., Chapdelaine, H., Falcone, E. L., Jamal, R., Luong, M. -L., Durand, M., Doucet, S., Carrier, F. -M., Coburn, B. A., Del Sorbo, L., Walmsley, S. L., Belga, S., Chen, L. Y., Mah, A. D., Steiner, T., Wright, A. J., Hajek, J., Adhikari, N., Daneman, N., Khwaja, K. A., Shahin, J., Gonzalez, C., Silva, R., Lindh, M., Maluenda, G., Fernandez, P., Oyonarte, M., Lasso, M., Boyer, A., Bronnimann, D., Bui, H. -N., Cazanave, C., Chaussade, H., Desclaux, A., Ducours, M., Duvignaud, A., Malvy, D., Martin, L., Neau, D., Nguyen, D., Pistone, T., Soubrane-Wirth, G., Leitao, J., Allavena, C., Biron, C., Bouchez, S., Gaborit, B., Gregoire, A., Le Turnier, P., Lecompte, A. -S., Lecomte, R., Lefebvre, M., Raffi, F., Boutoille, D., Morineau, P. H., Guery, R., Chatelus, E., Dumoussaud, N., Felten, R., Luca, F., Goichot, B., Schneider, F., Taquet, M. -C., Groh, M., Roumier, M., Neuville, M., Bachelard, A., Isernia, V., Phung, B. -C., Rachline, A., Sautereau, A., Vallois, D., Bleher, Y., Boucher, D., Coudon, C., Esnault, J., Guimard, T., Leautez-Nainville, S., Merrien, D., Morrier, M., Motte-Vincent, P., Gabeff, R., Leclerc, H., Cozic, C., Decours, R., Fevrier, R., Colin, G., Abgrall, S., Vignes, D., Sterpu, R., Kuellmar, M., Meersch-Dini, M., Weiss, R., Zarbock, A., Antony, C., Berger, M., Brenner, T., Taube, C., Herbstreit, F., Dolff, S., Konik, M., Schmidt, K., Zettler, M., Witzke, O., Boell, B., Garcia Borrega, J., Koehler, P., Zander, T., Dusse, F., Al-Sawaf, O., Kohler, P., Eichenauer, D., Kochanek, M., Shimabukuro-Vornhagen, A., Mellinghoff, S., Classen, A., Heger, J. -M., Meyer-Schwickerath, C., Liedgens, P., Heindel, K., Belkin, A., Biber, A., Gilboa, M., Levy, I., Litachevsky, V., Rahav, G., Finesod Wiedner, A., Zilberman-Daniels, T., Oster, Y., Strahilevitz, J., Sviri, S., Baldissera, E. M., Campochiaro, C., Cavalli, G., Dagna, L., De Luca, Giacomo., Della Torre, E., Tomelleri, A., Bernasconi De Luca, D., Capetti, A. F., Coen, M., Cossu, M. V., Galli, M., Giacomelli, A., Gubertini, G. A., Rusconi, S., Burastero, G. J., Digaetano, M., Guaraldi, G., Meschiari, M., Mussini, C., Puzzolante, C., Volpi, S., Aiello, M., Ariani, A., Chetta, A. A., Frizzelli, A., Ticinesi, A., Tuttolomondo, D., Aliberti, S., Blasi, F. B., Di Pasquale, M. F., Misuraca, S., Pilocane, T., Simonetta, E., Aghelmo, A. M., Angelini, C., Brunetta, E., Canonica, G. W., Ciccarelli, M., Dal Farra, S., De Santis, M., Ferri, S., Folci, M., Guidelli, G. M., Heffler, E. M., Loiacono, F., Malipiero, G., Paoletti, G., Pedale, R., Puggioni, F. A., Racca, F., Zumbo, A., Satou, M., Lisun, T., Protsenko, D., Rubtsov, N., Beloglazova, I., Fomina, D., Lysenko, M., Serdotetskova, S., Firstov, V., Gordeev, I., Kokorin, I., Komissarova, K., Lapochkina, N., Luchinkina, E., Malimon, V., Mamedguseyinova, S., Polubatonova, K., Suvorova, N., Arribas, J., Borobia Perez, A. M., de la Calle Prieto, F., Figueira, J. C., Motejano Sanchez, R., Mora-Rillo, M., Prados Sanchez, C., Queiruga Parada, J., Fernandez Arnalich, F., Guerro Barrientos, M., Bendala Estrada, A., Caballero Marcos, A., Garcia Leoni, M. E., Garcia-Martinez, R., Collado, A. M., Munoz Garcia, P., Torres do Rego, A., Villalba Garcia, M. V., Burrillo, A., Valerio Minero, M., Gijon Vidaurreta, P., Infante Herrero, S., Velilla, E., Machado, M., Olmedo, M., Pinilla, B., Almirante Gragera, B., Canas Ruano, M. D. L. E., Contreras Medina, S., Cortes Herrera, A., Falco Ferrer, V., Ferrer Roca, R., Nuvials Casals, X., Ribera Pascuet, E., Suanzes Diez, P., Rebollo Castro, P., Garcia Alcaide, F., Soriano, A., Oliver Caldes, A., Gonzalez Cordon, A., Cardozo, C., De la Mora Canizo, L., Pena Lopez, R., Chamorro, S., Crespillo-Andujar, C., Escudero Sanchez, R., Fortun-Abete, J., Monge-Maillo, B., Moreno Zamora, A., Norman, F., Sanchez Conde, M., Serrano Villar, S., and Vizcarra, P.

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Critical Care, International Cooperation, Population, Antibodies, Monoclonal, Humanized, Placebo, Severity of Illness Index, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Intensive care, Severity of illness, medicine, Clinical endpoint, Humans, Immunologic Factors, 030212 general & internal medicine, Mortality, education, Respiratory Distress Syndrome, education.field_of_study, Dose-Response Relationship, Drug, SARS-CoV-2, business.industry, Hazard ratio, COVID-19, Articles, Middle Aged, Receptors, Interleukin-6, Sarilumab, Treatment Outcome, 030228 respiratory system, Female, Drug Monitoring, Cytokine Release Syndrome, business
Abstract

Summary Background Elevated proinflammatory cytokines are associated with greater COVID-19 severity. We aimed to assess safety and efficacy of sarilumab, an interleukin-6 receptor inhibitor, in patients with severe (requiring supplemental oxygen by nasal cannula or face mask) or critical (requiring greater supplemental oxygen, mechanical ventilation, or extracorporeal support) COVID-19. Methods We did a 60-day, randomised, double-blind, placebo-controlled, multinational phase 3 trial at 45 hospitals in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain. We included adults (≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and pneumonia, who required oxygen supplementation or intensive care. Patients were randomly assigned (2:2:1 with permuted blocks of five) to receive intravenous sarilumab 400 mg, sarilumab 200 mg, or placebo. Patients, care providers, outcome assessors, and investigators remained masked to assigned intervention throughout the course of the study. The primary endpoint was time to clinical improvement of two or more points (seven point scale ranging from 1 [death] to 7 [discharged from hospital]) in the modified intention-to-treat population. The key secondary endpoint was proportion of patients alive at day 29. Safety outcomes included adverse events and laboratory assessments. This study is registered with ClinicalTrials.gov, NCT04327388; EudraCT, 2020-001162-12; and WHO, U1111-1249-6021. Findings Between March 28 and July 3, 2020, of 431 patients who were screened, 420 patients were randomly assigned and 416 received placebo (n=84 [20%]), sarilumab 200 mg (n=159 [38%]), or sarilumab 400 mg (n=173 [42%]). At day 29, no significant differences were seen in median time to an improvement of two or more points between placebo (12·0 days [95% CI 9·0 to 15·0]) and sarilumab 200 mg (10·0 days [9·0 to 12·0]; hazard ratio [HR] 1·03 [95% CI 0·75 to 1·40]; log-rank p=0·96) or sarilumab 400 mg (10·0 days [9·0 to 13·0]; HR 1·14 [95% CI 0·84 to 1·54]; log-rank p=0·34), or in proportions of patients alive (77 [92%] of 84 patients in the placebo group; 143 [90%] of 159 patients in the sarilumab 200 mg group; difference −1·7 [−9·3 to 5·8]; p=0·63 vs placebo; and 159 [92%] of 173 patients in the sarilumab 400 mg group; difference 0·2 [−6·9 to 7·4]; p=0·85 vs placebo). At day 29, there were numerical, non-significant survival differences between sarilumab 400 mg (88%) and placebo (79%; difference +8·9% [95% CI −7·7 to 25·5]; p=0·25) for patients who had critical disease. No unexpected safety signals were seen. The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group. Interpretation This trial did not show efficacy of sarilumab in patients admitted to hospital with COVID-19 and receiving supplemental oxygen. Adequately powered trials of targeted immunomodulatory therapies assessing survival as a primary endpoint are suggested in patients with critical COVID-19. Funding Sanofi and Regeneron Pharmaceuticals.

Published
2021

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