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1. Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort studyResearch in context

Author

Luis Jara-Palomares, Behnood Bikdeli, David Jiménez, Alfonso Muriel, Pablo Demelo-Rodríguez, Farès Moustafa, Aurora Villalobos, Patricia López-Miguel, Luciano López-Jiménez, Sonia Otálora, María Luisa Peris, Cristina Amado, Romain Chopard, Francisco Rivera-Cívico, Manuel Monreal, María Dolores Adarraga, Ana Alberich Conesa, Jesús Aibar, Alicia Alda Lozano, Joaquín Alfonso, Jesús Alonso Carrillo, María Angelina García, Juan Ignacio Arcelus, Aitor Ballaz, Raquel Barba, María Barca Hernando, Cristina Barbagelata, Manuel Barrón, Belén Barrón Andrés, Fahd Beddar Chaib, María Ángeles Blanco Molina, Juan Carlos Caballero, Gonzalo Castellanos, Leyre Chasco, Juan Criado, Cristina de Ancos, Jorge del Toro, Pablo Demelo Rodríguez, Cristina de Juana Izquierdo, Ana María Díaz Brasero, José Antonio Díaz Peromingo, Álvaro Dubois Silva, Juan Carlos Escribano, Concepción Falgá, Ana Isabel Farfán Sedano, Cleofe Fernández Aracil, Carmen Fernández Capitán, Begoña Fernández Jiménez, José Luis Fernández Reyes, María Ángeles Fidalgo, Iria Francisco, Cristina Gabara, Francisco Galeano Valle, Francisco García Bragado, Alberto García Ortega, Olga Gavín Sebastián, María Allende Gil de Gómez, Aída Gil Díaz, Covadonga Gómez Cuervo, Adriana González Munera, Enric Grau, Leticia Guirado, Javier Gutiérrez, Luis Hernández Blasco, Luis Jara Palomares, María Jesús Jaras, Rafael Jiménez, Inés Jou, María Dolores Joya, Sara Lainez Justo, Antonio Lalueza, Ramón Lecumberri, José Manuel León Ramírez, Pilar Llamas, José Luis Lobo, Luciano López Jiménez, Patricia López Miguel, Juan José López Núñez, Antonio López Ruiz, Juan Bosco López Sáez, Alicia Lorenzo, Marina Lumbierres, Olga Madridano, Ana Maestre, Pablo Javier Marchena, María Marcos, Mar Martín del Pozo, Francisco Martín Martos, Jorge Manuel Maza, Elisabeth Mena, Maria Isabel Mercado, Jorge Moisés, María del Valle Morales, Maria Sierra Navas, José Antonio Nieto, Manuel Jesús Núñez Fernández, Mónica Olid, Lucía Ordieres Ortega, María Ortiz, Jeisson Osorio, Remedios Otero, Nazaret Pacheco Gómez, Javier Pagán, Andrea Catalina Palomeque, Ezequiel Paredes, Pedro Parra Caballero, José María Pedrajas, Cristina Pérez Ductor, Montserrat Pérez Pinar, María Lourdes Pesce, José Antonio Porras, Ramón Puchades, Francisco Rivera Cívico, Ana Rodríguez Cobo, Vladimir Rosa, Marta Romero Brugera, Pedro Ruiz Artacho, Nuria Ruiz Giménez, Justo Ruiz Ruiz, Georgina Salgueiro, Teresa Sancho, Vanesa Sendín, Patricia Sigüenza, Silvia Soler, Susana Suárez Fernández, Raimundo Tirado, Ana Torrents Vilar, María Isabel Torres, Javier Trujillo Santos, Fernando Uresandi, Reina Valle, José Felipe Varona, Paula Villares, Cihan Ay, Stephan Nopp, Ingrid Pabinger, Matthias Engelen, Thomas Vanassche, Peter Verhamme, Hugo Hyung Bok Yoo, Ana Cristina Montenegro, Silvia Natalia Morales, Jairo Roa, Jana Hirmerova, Radovan Malý, Laurent Bertoletti, Alessandra Bura-Riviere, Judith Catella, Francis Couturaud, Olivier Espitia, Claire Grange, Barbara Leclercq, Raphael Le Mao, Isabelle Mahé, Ludovic Plaisance, Gabrielle Sarlon Bartoli, Pierre Suchon, Edouard Versini, Sebastian Schellong, Benjamin Brenner, Najib Dally, Inna Tzoran, Parham Sadeghipour, Fahrid Rashidi, Alessia Abenante, Giovanni Barillari, Manuela Basaglia, Franca Bilora, Daniele Bissacco, Cristiano Bortoluzzi, Barbara Brandolin, Renato Casana, Maurizio Ciammaichella, Donatella Colaizzo, Francesco Dentali, Pierpaolo Di Micco, Elvira Grandone, Egidio Imbalzano, Daniela Lambertenghi Deliliers, Federica Negro, Raffaele Pesavento, Alessandra Poz, Paolo Prandoni, Paolo Scarinzi, Carmine Siniscalchi, Beldisa Taflaj, Antonella Tufano, Adriana Visonà, Ngoc Vo Hong, Beniamino Zalunardo, Andris Skride, Dana Kigitovica, Samuel Fonseca, Rafael Marques, José Meireles, Sara Barbosa Pinto, Marijan Bosevsky, Aleksandra Eftimova, Marijan Zdraveska, Henri Bounameaux, Lucia Mazzolai, Avinash Aujayeb, Joseph Caprini, Ido Weinberg, and Hanh My Bui

Subjects
Pulmonary embolism, Venous thromboembolism, Anticoagulation, COVID-19, SARS-CoV-2, Medicine (General), R5-920
Abstract

Summary: Background: The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE. Methods: A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued. Findings: Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3–20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5–4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2–4.2). No patient died of recurrent PE (0%, 95% CI: 0–7.6%). Subgroup analyses showed that patients with diagnosis in 2021–2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45–5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19–4.49) had significantly higher rates of VTE recurrences. Interpretation: In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings. Funding: Sanofi and Rovi, Sanofi Spain.

Published
2024
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2. Treatment with tocilizumab or corticosteroids for COVID-19 patients with hyperinflammatory state: a multicentre cohort study (SAM-COVID-19)

Author

Jesús Rodríguez-Baño, Jerónimo Pachón, Jordi Carratalà, Pablo Ryan, Inmaculada Jarrín, María Yllescas, José Ramón Arribas, Juan Berenguer, Esther Aznar Muñoz, Pedro Gil Divasson, Patricia González Muñiz, Clara Muñoz Aguirre, Marta Díaz Menéndez, Fernando de la Calle Prieto, Marta Arsuaga Vicente, Elena Trigo Esteban, Ignacio Pérez Valero, Rosa de Miguel Buckley, Julen Cadiñaños Loidi, Beatriz Diaz Pollan, Luz Martín Carbonero, Juan Carlos Ramos Ramos, Belén Loeches Yagüe, Rocío Montejano Sánchez, Juan González García, Julio García Rodríguez, Margarita Ramírez, Isabel Gutiérrez, Francisco Tejerina, Teresa Aldámiz-Echevarría, Cristina Díez, Chiara Fanciulli, Leire Pérez-Latorre, Blanca Pinilla, Juan Carlos López, Ana Such Diaz, Elena Álvaro Alonso, Juan Torres Macho, Guillermo Cuevas Tascon, Eva Jiménez González de Buitrago, Fátima Brañas Baztán, Jorge Valencia de la Rosa, Mario Pérez Butragueño, Inés Fernández Jiménez, Gemma Muñiz Nicolás, Antonia Sepúlveda Berrocal, Alberto Gato Díez, María Pilar Toledano Sierra, María Paz García Butenegro, Ana Isabel Peláez Ballesta, Elena Morcillo Rodríguez, Isidoro Fernández Romero, Cristina Peláez Ballesta, María Isabel Guirado Torrecillas, Josune Goikoetxea Agirre, Elena Bereciartua Bastarrica, Laura Guio Carrión, Regino Rodríguez Álvarez, Marta Ibarrola Hierro, Isabel A. Pérez Hernández, Inés Pérez Zapata, Sergio Román Soto, Mohamed Kallouchi, Juan Ramón Domínguez Vicent, Rafae Silvariño Fernández, Jon Ugalde Espiñeira, Ainhoa Sanjuan López, Silvia García Martínez, Mikel Temprano Gogenola, Víctor Asensi, Silvia Suárez, Lucia Suárez, Carmen Yllera, María Rivas-Carmenado, Alberto Romero-Palacios, Jesús Ruiz Aragón, Patricia Jiménez Aguilar, Ma Luisa Fernández Ávila, Rosario Castilla Ortiz, Vanesa Alende Castro, Cristina Pérez García, Marta Fernández Morales, María Lorena María Valle Feijoo Begoña Rodríguez Ferreira, Joan Gómez-Junyent, Judit Villar-García, Inmaculada López-Montesinos, Itziar Arrieta-Aldea, Abora Rial-Villavecchia, Elisa García Vázquez, Aychel Elena Roura Piloto, Encarnación Moral Escudero, Alicia Hernández Torres, Helena Albendín Iglesias, David Vinuesa García, Clara Martínez Montes, Francisco Javier De la Hera Fernández, Francisco Anguita Santos, Andrés Ruiz Sancho, Vicens Díaz de Brito Fernández, Montserrat Sanmarti Vilamala, Sergio España Cueto, Daniel Molina Morant, Araceli González-Cuevas, Joel Elías Chara Cervantes, Guillem Policarpo Torres, Meritxell Ortega Montoliu, Mònica Angerri Nadal, Ariadna De Genover Gil, Eleni Patera, Rita Godoy Lorenzo, Evangelia Anna María Zioga, Virginia Isern Fernández, Carlos Enrique Sabbagh Fajardo, Ana Ferrer Ribera, Carlos Bea Serrano, Rosa Oltra Sempere, Sara Vela Bernal, Paloma Albiol Viñals, Miguel Pedromingo Kus, María Ángeles Garcinuño, Silvana Fiorante, Sergio Pérez Pinto, Alexandra de la Vega, María Carmen Fariñas Álvarez, Claudia González Rico, Francisco Arnaiz de las Revillas, Teresa Giménez, Jorge Calvo, Yolanda Meije Castillo, Alejandra Duarte Borges, Júlia Pareja Coca, Mercedes Clemente Presas, Xavier Sanz Salvador, Ma Teresa Pérez Rodríguez, Adrián Sousa, Alexandre Pérez González, Rebeca Longueira, Alejandro Araujo, Blanca Alonso Martínez, Laura García Escudero, Sara Lidia Kamel Rey, David Roa Alonso, Juan Pablo Avilés Parra, Iván Pelegrín Senent, Rosana Rouco Esteves Marques, Laia Raich Montiu, Jessica Souto Higueras, Manuel Alejandro Gálvez Bobadilla, Jorge Parra Ruiz, Violeta Ramos Sesma, Sara Velasco Fuentes, Laura García Pereña, Alfonso Lluna Carrascosa, Sergio Gilaberte Reyzábal, Mónica Liébana Gómez, Juan Salillas Hernando, Alberto Serrano Martínez, Miguel Torralba González de Suso, Patricia Martínez Martín, Isabel Rábago Lorite, Patricia González-Ruano Pérez, Beatriz Pérez-Monte Mínguez, Ángeles García Flores, Pere Comas Casanova, Andrea Martín Plata, Sergio Manuel Santana Báez, Oscar Sanz Peláez, Karim Mohamed Ramírez, José María Robaina Bordón, Helem Haydeé Vílchez Rueda, Melchor Riera Jaume, Gemma Mut Ramon, Meritxell Gavalda Manso, Lluis Planas Bibiloni, Laura Castelo Corral, Lucía Ramos Merino, Efrén Sánchez Vidal, María Rodríguez Mayo, Enrique Míguez Rey, José M. García de Lomas Guerrero, Javier De la Torre Lima, Ana Correa Ruiz, Fernando Fernández Sánchez, Nicolás Jiménez-García, José Luis Sierra-Monzón, Borja Gracia-Tello, María Hernández-Bonaga, Galadriel Pellejero, Marta Asín-Corrochano, Lucia Boix Palop, Esther Calbo, Cristina Badía, Beatriz Dietl, Gómez Lucía, Ángel Domínguez-Castellano, María José Ríos-Villegas, María D. del Toro, Zaira R. Palacios Baena, Elena Salamanca-Rivera, Elena Marín, Virginia Almadana, Salvador Pérez-Galera, Luisa González-Iglesias, Gabriela Abelenda-Alonso, Claudia Álvarez-Pouso, Francesc Escrihuela, Carlota Gudiol, Laia Lorenzo-Esteller, Jordi Niubó, Daniel Podzamczer, Miquel Pujol, Alexander Rombauts, Miguel Salvert Lletí, Ricardo Gil Sánchez, Marta Jiménez Escrig, Laura Parra Gómez, Mariona Tasias Pitarch, Marta Navarro Vilasaró, María Luisa Machado Sicilia, Aina Gomila Grange, Sonia Calzado Isbert, Nerea Carrasco Antón, Elizabet Petkova-Saiz, Alfonso Cabello Úbeda, Miguel Górgolas Hernández-Mora, Olga Sánchez-Pernaute, Carlos Dueñas Gutiérrez, Javier Martin Guerra, José Javier Castrodeza Sanz, Virginia Fernández Espinilla, Laura Rodríguez Fernández, Juan González-Moreno, Aroa Villoslada Gelabert, María Antonia Ribot Sanso, María Victoria Fernández-Baca, Almudena Hernández Milian, Miguel Ángel Morán Rodríguez, Zuriñe Ortiz de Zárate Ibarra, José Joaquin Portu Zapirain, Ester Saez de Adana Arroniz, Juan Carlos Gainzarain Arana, Olga Meca Birlanga, Ma Jesús del Amor Espín, Montserrat Viqueira González, Josefina García García, Onofre Martínez Madrid, Enrique Bernal Morell, Antonia Alcaraz, Ángeles Muñoz, Ignacio Pina, Vicente de la Rosa, Tamara Caínzos Romero, Sabela Sánchez Trigo, Ana Isabel Mariño Callejo, Hortensia Álvarez Díaz, Nieves Valcarce Pardeiro, Adriana Sánchez Serrano, Diana Piñar Cabezos, Eva Pilar García Villalba, Carmen Aguayo Jiménez, María Ruíz Campuzano, Virginia Naranjo Velasco, Marta Santos Peña, Juan Mora Delgado, Israel Sevilla Moreno, Cristina Lojo Cruz, Xabier Kortajarena Urkola, José Antonio Iribarren Loyarte, María Jesús Bustinduy Odriozola, Maialen Ibarguren Pinilla, Ignacio Álvarez Rodríguez, Francisco Javier Martínez Marcos, Francisco Javier Rodríguez Gómez, Isabel Asschert Agüero, Francisco Muñoz Beamud, Antonio José Ruiz Reina, Jara Llenas-García, Inmaculada González-Cuello, Elena Hellín-Valiente, Esther Martínez Birlanga, José Manuel Tafalla Torres, Jorge Calderón Parra, Gabriela Escudero López, Isabel Gutiérrez Martín, Ane Andrés Eisenhofer, Sonia García Prieto, Raquel Álvarez Franco, Daniel Roger Zapata, Blanca Martínez Cifre, Elena Aranda Rife, Irene Martín Rubio, André Barbosa Ventura, Javier Garrido, Concepción Gonzalo, Iván Piñero, Nieves de la Cruz Felipe, Eva Talavera García, Marta Lamata Subero, Paula Mendoza Roy, María Soledad García de Carlos, Justo Lajusticia Aisa, Lorea Arteche Eguizabal, Ainhoa Urrutia Losada, Saioa Domingo Echaburu, Pedro Ángel Cuadros Tito, Gurutz Orbe Narváez, Ma del Carmen Liébana Martos, Carolina Roldán Fontana, Carmen Herrero Rodríguez, Gaspar Duro Ruiz, Santiago Pérez Parra, Arantzazu Mera Fidalgo, Miquel Hortos Alsina, Ana Alberich Conesa, Lourdes Bladé Vidal, Nicolás Merchante Gutiérrez, Eva León Jiménez, Reinaldo Espíndola Gómez, María Erostarbe Gallardo, Pedro Martínez Pérez-Crespo, José Miguel Cisneros, Manuela Aguilar-Guisado, Teresa Aldabó, Claudio Bueno, Elisa Cordero-Matía, Ana Escoresca, Carmen Infante, Martín Guillermo, Sonsoles Salto, Francesca Gioia, Pilar Vizcarra, Jesús Fortún Abete, Pilar Martín Dávila, Santiago Moreno Guillén, José A. Oteo Revuelta, Concepción García-García, Paula Santibañez Sáenz, Cristina Cervera Acedo, José M. Azcona Gutiérrez, José María Reguera Iglesias, Antonio Plata Ciezar, Lucia Valiente de Santis, Beatriz Sobrino Diaz, Juan Diego Ruiz Mesa, Ministerio de Ciencia e Innovación, Fundación SEIMC/GeSIDA, Instituto de Salud Carlos III - ISCIII, European Regional Development Fund (ERDF/FEDER), Red Española de Investigación en SIDA, Red Española de Investigación en Patología Infecciosa, UAM. Departamento de Medicina, UAM. Departamento de Medicina Preventiva y Salud Pública y Microbiología, Universidad de Cantabria, SAM-COVID Study Group, [Rodríguez-Baño,J] Unidad Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Rodríguez-Baño,J, Pachón,J] Departamento de Medicina, Universidad de Sevilla, Spain. [Rodríguez-Baño,J, Pachón,J] Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain. [Pachón,J] Unidad Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Carratalà,J] Servei de Malalties Infeccioses, Hospital Universitari de Bellvitge, Barcelona, Spain. [Carratalà,J] Instituto de Investigación Biomédica de Bellvitge (IDIBELL), Barcelona, Spain. [Carratalà,J] Universitat de Barcelona, Barcelona, Spain. [Ryan,P] Servicio de Medicina Interna, Hospital Universitario Infanta Leonor, Madrid, Spain. [Jarrín,I] Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Madrid, Spain. [Yllescas,M] Fundación SEIMC/GeSIDA, Madrid, Spain. [Arribas,JR] Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain. [Arribas,JR] Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain. [Berenguer,J] Servicio de Microbiología Clínica y Enfermedades Infecciosas, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Berenguer,J] Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain., Ministerio de Ciencia e Innovación (España), Instituto de Salud Carlos III, Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF), Red de Investigación Cooperativa en Investigación en Sida (España), Red de Investigación Cooperativa en Investigación en Patología Infecciosa (España), Gilead Sciences, ViiV Healthcare, AbbVie Pharmaceuticals, Merck & Co, Janssen Biotech, Teva Pharmaceutical Industries, Ministerio de Ciencia, Innovación y Universidades (España), European Commission, Universidad de Sevilla. Departamento de Medicina, Instituto Carlos III (España), and Unión Europea

Subjects
0301 basic medicine, Male, law.invention, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], chemistry.chemical_compound, 0302 clinical medicine, Organisms::Viruses::RNA Viruses::Nidovirales::Coronaviridae [Medical Subject Headings], Randomized controlled trial, law, Adrenal Cortex Hormones, Clinical endpoint, Medicine, 030212 general & internal medicine, Hospital Mortality, Health Care::Environment and Public Health::Public Health::Epidemiologic Measurements::Demography::Vital Statistics::Mortality [Medical Subject Headings], Adrenocortical hormones, Hazard ratio, General Medicine, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Intubation::Intubation, Intratracheal [Medical Subject Headings], Middle Aged, Tocilizumab, Hospitalization, Infectious Diseases, Treatment Outcome, Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections [Medical Subject Headings], Drug Therapy, Combination, Female, Cohort study, Microbiology (medical), medicine.medical_specialty, Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections::Severe Acute Respiratory Syndrome [Medical Subject Headings], Combination therapy, Medicina, Hyperinflammatory state, 030106 microbiology, Estudios de cohortes, Antibodies, Monoclonal, Humanized, Article, 03 medical and health sciences, Internal medicine, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up Studies [Medical Subject Headings], Intubation, Intratracheal, Mortalitat, Humans, Corticosteroids, Mortality, Corticoesteroides, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings], Aged, Proportional Hazards Models, Retrospective Studies, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], Inflammation, business.industry, SARS-CoV-2, COVID-19, Odds ratio, Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Adrenal Cortex Hormones [Medical Subject Headings], Corticosteroides, COVID-19 Drug Treatment, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Probability::Propensity Score [Medical Subject Headings], chemistry, Spain, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies [Medical Subject Headings], Propensity score matching, Mortalidad, Monoclonal antibodies, business, Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Inflammation [Medical Subject Headings], Anticossos monoclonals
Abstract

© 2020 The Author(s)., [Objectives]: The objective of this study was to estimate the association between tocilizumab or corticosteroids and the risk of intubation or death in patients with coronavirus disease 19 (COVID-19) with a hyperinflammatory state according to clinical and laboratory parameters., [Methods]: A cohort study was performed in 60 Spanish hospitals including 778 patients with COVID-19 and clinical and laboratory data indicative of a hyperinflammatory state. Treatment was mainly with tocilizumab, an intermediate-high dose of corticosteroids (IHDC), a pulse dose of corticosteroids (PDC), combination therapy, or no treatment. Primary outcome was intubation or death; follow-up was 21 days. Propensity score-adjusted estimations using Cox regression (logistic regression if needed) were calculated. Propensity scores were used as confounders, matching variables and for the inverse probability of treatment weights (IPTWs)., [Results]: In all, 88, 117, 78 and 151 patients treated with tocilizumab, IHDC, PDC, and combination therapy, respectively, were compared with 344 untreated patients. The primary endpoint occurred in 10 (11.4%), 27 (23.1%), 12 (15.4%), 40 (25.6%) and 69 (21.1%), respectively. The IPTW-based hazard ratios (odds ratio for combination therapy) for the primary endpoint were 0.32 (95%CI 0.22–0.47; p < 0.001) for tocilizumab, 0.82 (0.71–1.30; p 0.82) for IHDC, 0.61 (0.43–0.86; p 0.006) for PDC, and 1.17 (0.86–1.58; p 0.30) for combination therapy. Other applications of the propensity score provided similar results, but were not significant for PDC. Tocilizumab was also associated with lower hazard of death alone in IPTW analysis (0.07; 0.02–0.17; p < 0.001)., [Conclusions]: Tocilizumab might be useful in COVID-19 patients with a hyperinflammatory state and should be prioritized for randomized trials in this situation., IJ has received honoraria for participating in an advisory board from Gilead Sciences, and for educational activities from ViiV. JB has received research grants from AbbVie, Gilead Sciences, Merck, and ViiV, and honoraria for being a speaker or advisory board participation from AbbVie, Gilead Sciences, Janssen, Merck, and ViiV. JRA received fees for participating in an advisory board, being a speaker, and research grant support from Viiv, Janssen, Gilead, MSD, Teva, Alexa and Serono. PR is involved as speaker or advisory board participant for Gilead Sciences, AbbVie and ViiV. JR-B, JP, JC and MY have no conflicts of interest to declare. SAM-COVID was funded by Spanish Ministry of Science and Innovation, Instituto de Salud Carlos III (COV20/01031) co-funded by European Union (ERDF/ESF, “Investing in your future”) and Fundación SEIMC/GeSIDA. In addition, Juan Berenguer, Jesús Rodríguez-Baño, Inmaculada Jarrín, Jordi Carratalá, Jerónimo Pachón, and José R Arribas received funding for research from Plan Nacional de I+D+i 2013-2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades – co- financed by European Development Regional Fund “A way to achieve Europe”, Operative program Intelligent Growth 2014–2020 through the networks: Spanish AIDS Research Network (RIS) [RD16/0025/0017 (JB), RD16/0025/0018 (JRA), RD16/0025/00XX (IJ)] and Spanish Network for Research in Infectious Diseases (REIPI)[RD16/0016/0001 (JRB), RD16/0016/0005 (JC), and RD16/0016/0009 (JP).

Published
2021

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