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All Studies   Meta Analysis       

Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia: A Randomized, Phase III Clinical Trial (SARTRE Study)

Sancho-López et al., Infectious Diseases and Therapy, doi:10.1007/s40121-021-00543-2, SARTRE
Oct 2021  
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Mortality -3% Improvement Relative Risk ICU admission 30% Brescia ≥ 2 -14% Brescia ≥ 3 at any moment.. -3% Brescia ≥ 3 at any mo.. (b) -3% primary Sarilumab  SARTRE  LATE TREATMENT  RCT Is late treatment with sarilumab beneficial for COVID-19? RCT 201 patients in Spain (August 2020 - March 2021) Lower ICU admission with sarilumab (not stat. sig., p=0.5) c19early.org Sancho-López et al., Infectious Diseas.., Oct 2021 Favorssarilumab Favorscontrol 0 0.5 1 1.5 2+
RCT 201 hospitalized COVID-19 pneumonia patients under standard oxygen therapy in Spain showing no significant difference with sarilumab treatment.
risk of death, 3.0% higher, RR 1.03, p = 0.98, treatment 2 of 99 (2.0%), control 2 of 102 (2.0%), adjusted per study, day 28.
risk of ICU admission, 30.0% lower, RR 0.70, p = 0.50, treatment 7 of 99 (7.1%), control 10 of 102 (9.8%), NNT 37, adjusted per study, day 28.
Brescia ≥ 2, 14.0% higher, RR 1.14, p = 0.66, treatment 40 of 99 (40.4%), control 40 of 102 (39.2%), adjusted per study, day 28.
Brescia ≥ 3 at any moment, 3.0% higher, RR 1.03, p = 0.94, treatment 40 of 99 (40.4%), control 40 of 102 (39.2%), adjusted per study, day 28.
Brescia ≥ 3 at any moment, 3.0% higher, RR 1.03, p = 0.94, treatment 40 of 99 (40.4%), control 40 of 102 (39.2%), adjusted per study, day 14, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sancho-López et al., 17 Oct 2021, Randomized Controlled Trial, Spain, peer-reviewed, median age 60.0, 22 authors, study period 4 August, 2020 - 23 March, 2021, SARTRE trial. Contact: asancho.hpth@gmail.com, bruizantoran@gmail.com.
This PaperSarilumabAll
Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia: A Randomized, Phase III Clinical Trial (SARTRE Study)
Aránzazu Sancho-López, Antonio F Caballero-Bermejo, Belén Ruiz-Antorán, Elena Múñez Rubio, Mercedes García Gasalla, Juan Buades, Marta González Rozas, María López Veloso, Ana Muñoz Gómez, Ana Cuenca Abarca, Pedro Durán Del Campo, Fátima Ibáñez, Alberto Díaz De Santiago, Yolanda Romero, Jorge Calderón, Ilduara Pintos, Adrián Ferre Beltrán, Gustavo Centeno Soto, José Campos, Antonio Ramos Martínez, Cristina Avendaño-Solá, Ana Fernández Cruz, Aránzazu Sancho-López, Antonio F Bermejo Caballero, Belén Ruiz-Antorán, Ana Fernández-Cruz, Elena Múñez, Antonio Ramos Martínez, Cristina Avendaño-Solá, Elena Diago-Sempere, Pedro Durán Del Campo, Fátima Ibáñez, Alberto Díaz De Santiago, Yolanda Romero, Jorge Calderón Parra, Ilduara Pinto, Gustavo Centeno, Concepción Payares, Almudena Ramírez-García, Laura Javaloyes, María De La Encina Higuera, Rocío Layunta Acero, Laura Vicente, Paloma Rodríguez Araque, Piedad Ussetti-Gil, Rosa Malo De Molina, Andrea Trisan Alonso, Manuel Valle Falconés, Fernando Montoya, María Luisa Jiménezjiménez, Laura Ferrer, Jorge Ramos, Alejandro Junco, José Campos, Alejandro Callejas Díaz, Sara De La Fuente Moral, Pedro Laguna, Gema Vázquez Contreras, Alejandro Muñoz Serrano, Isolina Baños Pérez, Víctor Moreno Torres-Concha, Alfonso Ángel-Moreno Maroto, Esther Montero Hernández, Mª Carmen Máinez Saíz, Mª Cruz Carreño Hernández, Rosa Muñoz De Benito, Susana Mellor Pita, Pablo Tutor De Ureta, Miriam Aguilar Pérez, Gema Díaz Nuevo, Christian García Fadul, Beatriz Jara Chinarro, Rosalía Laporta Hernández, María Lázaro De La Fuentecarrasco, Cristina López García Gallo, Patricia Mínguez Clemente, Roberto Carabias Arca, Marta Erro Iribarreniribarren, Ane Andrés Eisenhofer, Itziar Diego Yagüe, Ignacio Donate Velascovelasco, Gabriela Escudero López, Esther Expósito Palomo, Amy Galán Gómez, Sonia García Prieto, Javier Gómez Irusta, Edith Vanessa Gutiérrez Abreu, Isabel Gutiérrez Martín, Ángela Gutiérrez Rojas, Andrea Gutiérrez Villanueva, Jesús Herráiz Jiménez, María Martínez Urbistondo, Fernando Martínez Vara, Patricia Mills Sánchez, Alberto Mora Vargas, Ignacio Morrás De La Torre, Enrique Sánchez Chica, Ángela Valencia Alijo, Jos Manuel Vázquez Comendador, Ana Arias Milla, Juan Antonio Vargas Núñez, Valentín Cuervas-Mons Martínez, Carmen Cubero, Celia Rodríguez Olleros, Elvira Ramos Carral, Yale Tung, Mercedes García Gasalla, Adrián Ferré Beltrán, Pere Ventayol Bosch, Juana Maria Ferrer Balaguer, Francisca Artigues Serra, Alfredo Manuel Santos Pinheiro, Helem H Rueda Vilchez, Antonio Palomero, Ana Muñoz Gómez, Francisco Javier Teigell Muñoz, Elena García Guijarro, Francisco García Sánchez, José Antonio Melero Bermejo, María Mateos González, Aitor Olmo Sánchez, Juan Vicente De La Sota, Elena Matilla, María López Veloso, Julio Barraza Vengoechea, Enrique Iglesias Julián, Ana Marta Espeja Martínez, Fernando Orza García, Luis Buzón Martin, Marta Ubeira Iglesias, Ana Belén Cuenca Abarca, Pedro Gargantilla Madera, Luis Miguel Belda Bilbao, Juan Francisco Montoro Lara, Almudena García Tobaruela, Francisco Javier Montero Jiménez, Silvana Emilise Fiorante, Susana Sánchez Suárez, Carolina Aguilar Casado, Carla Ruth Mejía Medina, Pablo Carrasco Lara, María Isabel Barcia Martín, Mercedes García Gimeno, Juan Buades, Inés Losada, Aroa Villoslada, Salvador Pons, Monserrat Vilanova, Adrián Rodríguez, Eugenia Cisneros Barroso, Mónica Sanz, Marta González Rozas, Pablo Bachiller Luque, Ana Carrero Gras, Raquel Coloma Peral, Mª Teresa Criado Illana, Eva Ferreira Pasospasos, Laura Martin Ventura, Javier Moreno Palomares, Fuencisla Gómez Ruiz
Infectious Diseases and Therapy, doi:10.1007/s40121-021-00543-2
Introduction: SARS-CoV-2 pneumonia is often associated with hyper-inflammation. The cytokine-storm-like is one of the targets of current therapies for coronavirus disease 2019 . High Interleukin-6 (IL6) blood levels have been identified in severe COVID-19 disease, but there are still uncertainties regarding the actual role of anti-IL6 antagonists in COVID-19 management. Our hypothesis was that the use of sarilumab plus corticosteroids at an early stage of the hyper-inflammatory syndrome would be beneficial and prevent progression to acute respiratory distress syndrome (ARDS). Methods: We randomly assigned (in a 1:1 ratio) COVID-19 pneumonia hospitalized patients under standard oxygen therapy and laboratory evidence of hyper-inflammation to receive sarilumab plus usual care (experimental group) or Antonio F.
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Who, Therapeutics and COVID19: living guidance
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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