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FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities

2022; Adis, Springer Healthcare; Volume: 42; Issue: 11 Linguagem: Inglês

10.1007/s40261-022-01201-2

1179-1918

José Hernández‐Rodríguez, Julio Durán-Sanclemente, Sergio Prieto‐González, Olga Araújo, Teresa Hospital-Vidal, Georgina Casanovas, Víctor Sapena, José Luís Blanco, Alfonso López‐Soto, Francisco Javier Afonso Afonso, Jesús Aibar, Xavier Alemany, Luís Antón Aparicio, Yolanda Asensio, Anna Aldea-Parés, Ana Belén Azuaga, Giuseppe Barilaro, Nieves Benages, Katherine Cajiao, Júlia Calvo, Maria del Carme Cañueto, Aina Capdevila-Reniu, Irene Carbonell, Miriam Costafreda, Cecilia Cuzco, Anna de-Daniel-Bisbe, Gema Doménech, Mónica Doménech, Gerard Espinosa, María Elena Guerra Feliu, Alberto Foncillas, Cristina Gabara, Gloria Gámez, Carlos García-Gutiérrez, Lucía García-Jarque, Andrea García-Ortega, Begoña Gómez, Verónica Gómez‐Caverzaschi, Vanesa Gómez-Urbano, Tania Gonzalo, Ignacio Grafiá, Neus Guasch, Mar Guillén, Ana Guio, Marta Illa, Marco Inzitari, Maria Joyera, Andrea Ladino, Irina Luzko Scheid, Gema M. Lledó, Néstor López-Guerra, Daniel De Marco, G. Masdeu, Ana Matas-García, Irene Macaya, Ferrán Masanés, Miriam I. Mayor, José C. Milisenda, M. Angels Montero, Verónica Montes, Marc Montoya-Rodés, Núria Moragas, Alma Morancho, Pedro Moreno, José Naval-Álvarez, Josep Ortega, Anna Pahisa, Martina Pellicé, Sona Pilarcikova, E. Pujol, Elisabet Rivero, Joan Ribot, Roberto Ríos‐Garcés, Olga Rodríguez-Núñez, Omar Saavedra, Emilio Sacanella, A. López Ruiz de Salazar, Adriana San‐Miguel, Amparo Sánchez-Buitrago, Víctor Sánchez-Palacios, Ángeles Sanz, Ferran Seguí, Adrià Tomé-Pérez, Manuel Torres-Elorza, Montse Tuset, Helena Ventosa, Roser Ventura, Esther Viñas-Esmel, Carles Zamora,

Inflammasome and immune disorders

Unprotected and fragile elderly people in nursing homes experienced the highest mortality rates during the initial coronavirus disease 2019 (COVID-19) pandemic. Our aim was to study the role of two oral anti-inflammatory drugs, colchicine and prednisone, in elderly patients with COVID-19 in geriatric centers. A phase II/III, randomized, controlled, multicenter clinical trial was performed in a geriatric population comparing the efficacy and safety of an oral combination of prednisone (60 mg/day for 3 days) and colchicine (at loading doses of 1–1.5 mg/day for 3 days, followed by 0.5 mg/day for 11 days) with the standard treatment, based on intravenous dexamethasone. Primary endpoints assessed the efficacy in reducing death or the modified endpoint death/therapeutic failure to the study drugs over a 28-day period, while secondary endpoints included safety, laboratory changes, and additional therapies used. Fifty-four patients (35 female/19 male) were enrolled, 25 (46.3%) of whom were allocated to the experimental arm and 29 (53.7%) to the control arm. At day 28, no differences in deaths were observed. The combination of mortality or therapeutic failure occurred in 12 (45.13%) patients receiving dexamethasone and 6 (28.13%) patients receiving colchicine/prednisone, resulting in a reduction of risk difference (RD) of − 17% (p = 0.17), with an average reduction of 39% (risk ratio [RR] 0.61) in patients receiving colchicine/prednisone (p = 0.25). Control patients received higher amounts of additional glucocorticoids (p = 0.0095) over a longer time frame (p = 0.0003). Colchicine/prednisone significantly reduced ferritin levels at day 14, as well as d-dimer and lactate dehydrogenase (LDH) levels at day 28. Adverse events were similar in both groups. The combination colchicine/prednisone compared with intravenous dexamethasone has shown a remarkable trend to increase disease survival over a 28-day period in elderly patients requiring oxygen therapy in geriatric centers, without safety issues. Clinical Trials Registration Number: NCT04492358.