16 results on '"Luong, M. -L."'
Search Results
2. Risk Factors for Voriconazole Hepatotoxicity at 12 Weeks in Lung Transplant Recipients
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Luong, M-L., Hosseini-Moghaddam, S. M., Singer, L. G., Chaparro, C., Azad, S., Lazar, N., Boutros, P. C., Keshavjee, S., Rotstein, C., and Husain, S.
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- 2012
- Full Text
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3. Lactobacillus probiotic use in cardiothoracic transplant recipients: a link to invasive Lactobacillus infection?
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Luong, M.-L., Sareyyupoglu, B., Nguyen, M. H., Silveira, F. P., Shields, R. K., Potoski, B. A., Pasculle, W. A., Clancy, C. J., and Toyoda, Y.
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- 2010
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4. Prospective evaluation of clinical utility and pronostic value of broncho-alveolar lavage galactomannan assay in haematology-oncology patients: O246
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Luong, M. L., Filion, C., Labbe, A. C., Cardin-Tourigny, J., Carrignan, S., Belanger, S., Roy, J., and Laverdiere, M.
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- 2009
5. Perspectives on Scedosporium species and Lomentospora prolificans in lung transplantation: Results of an international practice survey from ESCMID fungal infection study group and study group for infections in compromised hosts, and European Confederation of Medical Mycology
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Rammaert, B., Puyade, M., Cornely, O. A., Seidel, D., Grossi, P., Husain, S., Picard, C., Lass-Florl, C., Manuel, O., Le Pavec, J., Lortholary, O., Nagel, C., Westall, G., Morrissey, O., Chambers, D., Eschertzhuber, S., Coussement, J., Knoop, C., Vos, R., Dupont, L., Dumonceaux, M., Campos, S. V., Kabbani, D., Cervera, C., Luong, M. -L., Blanchard, E., Senechal, A., Pavec, J. L., Brugiere, O., Boussaud, V., Guillemain, R., Bervar, J. -F., Claustre, J., Haloun, A., Hirschi, S., Reynaud, M., Kneidinger, N., Gottlieb, J., Roilides, E., Zarrinfar, H., Rosso, L., Morlacchi, L. C., Dell'Amore, A., Loy, M., Santos, C. O. D., Rello, J., Monforte, V., Martin-Gomez, M. T., Medrano, F. L., Fernandez-Ruiz, M., Sole, A., Cifrian, J. M., Neofytos, D., Mueller, N., Benden, C., Brill, A. K., Kiyan, E., Gould, K., Gkrania-Klotsas, E., David, M., Weigt, S., Kwak, E. J., Silveira, F., Hadjiliadis, D., Baddley, J., Danziger-Isakov, L., Bhorade, S., Ison, M., Wolfe, C., Aslam, S., Budem, M., Musetti, A., Centre hospitalier universitaire de Poitiers (CHU Poitiers), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers, Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), University Hospital of Cologne [Cologne], Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases - CECAD [Cologne, Germany] (Institute for Genetics), University of Cologne, German Centre for Infection Research (DZIF), Universitá degli Studi dell’Insubria = University of Insubria [Varese] (Uninsubria), University Health Network, Hôpital Foch [Suresnes], Leopold Franzens Universität Innsbruck - University of Innsbruck, Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Centre Chirurgical Marie Lannelongue (CCML), Hypertension arterielle pulmonaire physiopathologie et innovation thérapeutique, Centre Chirurgical Marie Lannelongue (CCML)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris-Sud - Paris 11 - Faculté de médecine (UP11 UFR Médecine), Université Paris-Sud - Paris 11 (UP11), Université Paris-Saclay, Centre d'infectiologie Necker-Pasteur [CHU Necker], Institut Pasteur [Paris] (IP)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Mycologie moléculaire - Molecular Mycology, Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS), Centre National de Référence Mycologie et Antifongiques-Mycologie Moléculaire (CNRMA), Institut Pasteur [Paris] (IP), The authors thank all the people who helped to collect mycological data and to contact transplant centers: Alejandro Mario Bertolotti (Buenos Aires, Argentina), Claire Heney (Brisbane, Australia), Carlota Montesinos (Brussels, Belgium), Katrien Lagrou (Leuven, Belgium), Youri Gluczynski (Yvoir, Belgium), Sandrine Houze (Paris, France), Eric Dannaoui (Paris, France), Florent Morio (Nantes, France), Murielle Cornet (Grenoble, France), Valérie Bru (Strasbourg, France), Stéphane Ranque (Marseille, France), Emilie Cardot (Suresnes, France), Ludwig Sedlacek (Hannover, Germany), Maurizio Sanguinetti (Roma, Italy), Ana Alastruey (Madrid, Spain), Konrad Muehlethaler (Bern, Switzerland), Kevin Alby (Philadelphia, USA), Malcom Richardson (Manchester, UK), the members of the ESCMID Fungal Infection Study Group (EFISG) and Study Group for Infections in Compromised Hosts (ESGICH) and European Confederation of Medical Mycology (ECMM) who helped to promote the study, Jeffrey Arsham for editing our original English language manuscript., The SCEDO‐LUNG collaborative group collected the data., University of Insubria, Varese, University of Innsbruck, Centre chirurgical Marie Lannelongue, Centre chirurgical Marie Lannelongue-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut Pasteur [Paris], Institut Pasteur [Paris]-Centre National de la Recherche Scientifique (CNRS), and Institut Pasteur [Paris]
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Internationality ,[SDV]Life Sciences [q-bio] ,invasive fungal disease ,lomentosporiosis ,scedosporiosis ,solid organ transplantation ,Ascomycota ,Humans ,Lung Transplantation ,Mycoses ,Prospective Studies ,Respiratory Tract Infections ,Scedosporium ,Surveys and Questionnaires ,Disease Management ,Immunocompromised Host ,MESH: Mycoses/epidemiology ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,MESH: Mycoses/etiology ,MESH: Surveys and Questionnaires ,[SDV.MP.MYC]Life Sciences [q-bio]/Microbiology and Parasitology/Mycology ,MESH: Respiratory Tract Infections/etiology ,MESH: Humans ,MESH: Respiratory Tract Infections/microbiology ,MESH: Scedosporium/isolation & purification ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,MESH: Lung Transplantation/adverse effects ,MESH: Prospective Studies ,MESH: Disease Management ,MESH: Internationality ,MESH: Ascomycota/isolation & purification ,MESH: Immunocompromised Host - Abstract
International audience; Background: Scedosporium species and Lomentospora prolificans (S/L) are the second most common causes of invasive mold infections following Aspergillus in lung transplant recipients.Methods: We assessed the current practices on management of S/L colonization/infection of the lower respiratory tract before and after lung transplantation in a large number of lung transplant centers through an international practice survey from October 2016 to March 2017.Results: A total of 51 respondents from 45 lung transplant centers (17 countries, 4 continents) answered the survey (response rate 58%). S/L colonization was estimated to be detected in candidates by 48% of centers. Only 18% of the centers used a specific medium to detect S/L colonization. Scedosporium spp. colonization was a contraindication to transplantation in 10% of centers whereas L prolificans was a contraindication in 31%; 22% of centers declared having had 1-5 recipients infected with S/L in the past 5 years.Conclusions: This survey gives an overview of the current practices regarding S/L colonization and infection in lung transplant centers worldwide and underscores the need of S/L culture procedure standardization before implementing prospective studies.
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- 2019
6. The 2015 International Society for Heart and Lung Transplantation Guidelines for the management of fungal infections in mechanical circulatory support and cardiothoracic organ transplant recipients: Executive summary.
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Husain, S, Sole, A, Alexander, BD, Aslam, S, Avery, R, Benden, C, Billaud, EM, Chambers, D, Danziger-Isakov, L, Fedson, S, Gould, K, Gregson, A, Grossi, P, Hadjiliadis, D, Hopkins, P, Luong, M-L, Marriott, DJE, Monforte, V, Muñoz, P, Pasqualotto, AC, Roman, A, Silveira, FP, Teuteberg, J, Weigt, S, Zaas, AK, Zuckerman, A, Morrissey, O, Husain, S, Sole, A, Alexander, BD, Aslam, S, Avery, R, Benden, C, Billaud, EM, Chambers, D, Danziger-Isakov, L, Fedson, S, Gould, K, Gregson, A, Grossi, P, Hadjiliadis, D, Hopkins, P, Luong, M-L, Marriott, DJE, Monforte, V, Muñoz, P, Pasqualotto, AC, Roman, A, Silveira, FP, Teuteberg, J, Weigt, S, Zaas, AK, Zuckerman, A, and Morrissey, O
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- 2016
7. A 58-Year-Old Renal Transplant Recipient With Fever and Progressive Dyspnea
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St-Pierre, J., primary, Rioux-Masse, B., additional, Hou, H., additional, Savard, P., additional, and Luong, M.-L., additional
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- 2014
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8. Does CMV Mismatch Status Modify the Risk of PTLD Due to EBV Mismatch Status in Lung and Heart Transplant Recipients?
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Luong, M.-L., primary, Kim, J., additional, Rotstein, C., additional, and Husain, S., additional
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- 2013
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9. 317 Invasive Aspergillosis (IA) in Cystic Fibrosis Patients Undergoing Lung Transplantation, 2006-2010
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Luong, M.-L., primary, Chaparro, C., additional, Stephenson, A., additional, Singer, L.G., additional, Azad, S., additional, Keshavjee, S., additional, Waters, V., additional, Rotstein, C., additional, Tullis, E., additional, and Husain, S., additional
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- 2012
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10. 687 Incidence of Azole Resistance in Aspergillus Fumigatus among Lung Transplant Recipients (LTRs)
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Luong, M.-L., primary, Howard, S., additional, Richardson, S.E., additional, Singer, L.G., additional, Chaparro, C., additional, Keshavjee, S., additional, Akinlolu, Y., additional, Azad, S., additional, Rotstein, C., additional, Mazzulli, T., additional, and Husain, S., additional
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- 2012
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11. Comparison of an Aspergillus Real-time Polymerase Chain Reaction Assay With Galactomannan Testing of Bronchoalvelolar Lavage Fluid for the Diagnosis of Invasive Pulmonary Aspergillosis in Lung Transplant Recipients
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Luong, M.-L., primary, Clancy, C. J., additional, Vadnerkar, A., additional, Kwak, E. J., additional, Silveira, F. P., additional, Wissel, M. C., additional, Grantham, K. J., additional, Shields, R. K., additional, Crespo, M., additional, Pilewski, J., additional, Toyoda, Y., additional, Kleiboeker, S. B., additional, Pakstis, D., additional, Reddy, S. K., additional, Walsh, T. J., additional, and Nguyen, M. H., additional
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- 2011
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12. 603 Latent Mycobacterial Disease in Patients with End-Stage Lung Disease: One Name, a Spectrum of Diseases
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Luong, M.-L., primary, Clancy, C.J., additional, Kwak, E.J., additional, Silveira, F., additional, Abdel-Massih, R., additional, Toyoda, Y., additional, Pilewski, J., additional, Crespo, M., additional, Bermudez, B., additional, Bhama, J.K., additional, and Nguyen, M.H., additional
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- 2011
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13. 433 Risk Factors for Voriconazole Hepatotoxicity in Lung Transplant Recipients
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Luong, M.-L., primary, Hosseini-Moghaddam, S.M., additional, Singer, L.G., additional, Chapparo, C., additional, Keshavjee, S., additional, Lazar, N., additional, Azad, S., additional, Rotstein, C., additional, and Husain, S., additional
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- 2011
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14. Leptospirosis: pulmonary hemorrhage in a returned traveller
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Leung, V., primary, Luong, M.-L., additional, and Libman, M., additional
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- 2011
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15. Letter: the safety of herpes zoster vaccination for patients with inflammatory bowel disease being treated with anti‐TNF medications.
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Côté‐Daigneault, J., Luong, M. L., Colombel, J.‐F., and Peerani, F.
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HERPES zoster vaccines , *INFLAMMATORY bowel diseases , *VACCINE effectiveness - Published
- 2018
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16. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial
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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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