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0 0.5 1 1.5 2+ Mortality -16% Improvement Relative Risk Mortality/therapeutic fail.. 42% Hernández-Rodríguez et al. NCT04492358 FRAGILE-COLCOVID19 Colchicine RCT LATE Is late treatment with colchicine+prednisone beneficial for COVID-19? RCT 54 patients in Spain (March - October 2020) Trial compares with dexamethasone, results vs. placebo may differ Trial underpowered to detect differences Hernández-Rodríguez et al., Clinical Drug Invest.., doi:10.1007/s40261-022-01201-2 Favors colchicine Favors dexamethasone
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
Hernández-Rodríguez et al., Clinical Drug Investigation, doi:10.1007/s40261-022-01201-2, FRAGILE-COLCOVID19, NCT04492358 (history)
Hernández-Rodríguez et al., FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and.., Clinical Drug Investigation, doi:10.1007/s40261-022-01201-2, FRAGILE-COLCOVID19, NCT04492358
Sep 2022   Source   PDF  
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RCT 54 elderly patients in Spain comparing colchicine + prednisone vs. dexamethasone, showing lower combined mortality/therapeutic failure with colchicine + prednisone, but no significant difference in mortality. Data appears unreliable, for example authors report 5 deaths (20.97%) in the control arm, however 20.97% does not match the reported (or any) number of patients. Similarly for combined mortality/therapeutic failure where authors report 12 (45.13%) and 6 (28.13%).
risk of death, 16.0% higher, RR 1.16, p = 1.00, treatment 5 of 25 (20.0%), control 5 of 29 (17.2%).
mortality/therapeutic failure, 42.0% lower, RR 0.58, p = 0.25, treatment 6 of 25 (24.0%), control 12 of 29 (41.4%), NNT 5.8, combined mortality/therapeutic failure.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Hernández-Rodríguez et al., 29 Sep 2022, Randomized Controlled Trial, Spain, peer-reviewed, 90 authors, study period March 2020 - October 2020, this trial compares with another treatment - results may be better when compared to placebo, this trial uses multiple treatments in the treatment arm (combined with prednisone) - results of individual treatments may vary, trial NCT04492358 (history) (FRAGILE-COLCOVID19).
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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
José Hernández-Rodríguez, Julio Durán-Sanclemente, Sergio Prieto-González, Olga Araújo, Teresa Hospital-Vidal, Georgina Casanovas, Víctor Sapena, José Luis Blanco, Alfonso López-Soto, Francisco J Afonso, Jesús Aibar, Xavier Alemany, Luis Aparicio, Yolanda Asensio, Anna Aldea-Parés, Ana B 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, Maria 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 Grafia, Neus Guasch, Mar Guillén, Ana M Guió, Marta Illa, Marco Inzitari, Maria Joyera, Andrea Ladino, Irina S Luzko-Scheid, Gema M Lledó, Néstor López-Guerra, Daniel Marco, Guillem Masdeu, Ana Matas-García, Irene Macaya, Ferran Masanés, Miriam I Mayor, José C Milisenda, Montse Montero, Verónica Montes, Marc Montoya-Rodés, Núria Moragas, Alma Morancho, Pedro J Moreno, José Naval, Josep Ortega, Anna Pahisa, Martina Pellicé, Sona Pilarcikova, Ester Pujol, Elisabet Rivero, Joan Ribot, Roberto Ríos-Garcés, Olga Rodríguez-Núñez, Omar M Saavedra, Emilio Sacanella, Adelaido 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
Clinical Drug Investigation, doi:10.1007/s40261-022-01201-2
Background Unprotected and fragile elderly people in nursing homes experienced the highest mortality rates during the initial coronavirus disease 2019 (COVID-19) pandemic. Objective 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. Methods 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. Results 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. Conclusions 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.
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1007/ s40261-022-01201-2. Declarations Conflict of interest José Hernández-Rodríguez, Julio Durán-Sanclemente, Sergio Prieto-González, Olga Araújo, Teresa Hospital-Vidal, Georgina Casanovas, Víctor Sapena, José Luis Blanco, and Alfonso López-Soto declare no conflicts of interest in this work. Ethics approval This study was approved by the Clinical Research Ethics Committee at the Hospital Clínic of Barcelona (EudraCT Number 2020-002462-14). Consent to participate All patients or legally authorized representatives signed the informed consent form. Consent for publication Not applicable. Author contributions JHR and JLB were involved in the conceptualization and design of the study protocol. ALS and JDS allowed the launch of the study by providing the geriatric facilities and encouraging the participation of their healthcare personnel. JDS, SPG, OA, THV, and all Members of the FRAGILE-COLCOVID19 Study Group recruited patients, collected data, and/or monitored patients enrolled in the study. VS and GC performed the statistical analysis and summarized the statistical data for the manuscript. JHR was responsible for funding acquisition, project administration and data analysis, and wrote the manuscript. All authors contributed to the critical revision and editing of the manuscript and approved its final version. Open Access This article is licensed under a..
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Late treatment
is less effective
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