¿Lo hicimos todo bien con la COVID-19?. José Ramón Arribas López. Jefe de Sección de Medicina Interna del Hospital Universitario La Paz. Profesor titular. Universidad Autónoma de Madrid.N

Arribas López, José Ramón

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Jose R ArribasInfectious Diseases UnitLa Paz University Hospital@jrarribas¿Lo hicimos todo bien con la COVID-19?Luces y sombras de la investigaciónDISCLOSURES• Gilead• Merck• GSK• Lilly• Roche• Pfizer• SobiSOMBRAS15https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdfJose Ramón ArribasHospital La PazMadrid@jrarribas4/Marzo/2020No hay ningún tratamiento directo con eficacia demostrada4/Marzo/2020Potential repurposing candidates for 2019-nCoV• Favipiravir• Ribavirin• Galidesivir• Favipiravir plus interferon-α (ChiCTR2000029600)• Favipiravir plus baloxavir marboxil (an approved influenza inhibitortargeting the cap-dependent endonuclease) (ChiCTR2000029544).• Chloroquine and is being evaluated in an open-label trial (ChiCTR2000029609)• Convalesctent plasma4/Marzo/2020Published online February 6, 2020 https://doi.org/10.1016/S0140-6736(20)30317-24/Marzo/2020Jose R ArribasInfectious Diseases UnitLa Paz University Hospital@jrarribas¿Lo hicimos todo bien con la COVID-19?Luces y sombras de la investigaciónCasi 3 años despuésFármacos1.  How does coronavirus kill? Clinicians trace a ferocious rampage through the body, from brain to toes | Science | AAAS. 2020;1–10. COVID-19 TREATMENTO2, VNI, VMANTICOAGULATIONANTIVIRALSMONOCLONAL ANTIBODIESIMMUNOMODULATIONIMMUNOSUPPRESSED LONG COVIDNEUMÓLOGOSINTENSIVISTASINFECTOLOGOSINTERNISTASTROPICALISTASINTERNISTASREUMATOLOGOSINMUNOLOGOSINTERNISTASHEMATOLOGOSCARDIOLOGOSDECISIONES TERAPEUTICAS CUANDO NO HAY TRATAMIENTOS EFICACESTRATAR• “Si no hago algo se va a morir”• “X funciona in vitro”• “Tiene sentido utilizarlo”• “En el hospital X lo están usando”• ”Hay datos en animales”• “A mi me ha ido bien”• “Lo ha dicho un experto”• “No es ético que le pueda tocar placebo”• “No podemos esperar a los resultados de los ensayos”• ”No tengo ningún ensayo clínico disponible”NO TRATAR• Si no hacemos un EECC nunca sabremos si X es eficaz• X puede ser tóxico e ineficaz• El voluntario al menos tiene un X% de que le toque tratamiento activo• Es ahora cuando es más importante hacer el EECC• A common interpretation of off-label use and compassionate use of drugs is that is that if thepatient died, they died from the disease, but if the patient survived, they survived because of thegiven drug. This is not true.• If the disease is not 100% lethal and it is not known whether the experimental drug would help orharm a patient (ie, a situation with true equipoise), then it is ethical to conduct an RCT. Without a control group, it is not possible to accurately determine the harms of any experimental drugKalil AC. Treating COVID-19—Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics. JAMA [Internet] 2020 [cited 2022 Nov 17];323(19):1897–8. Available from: https://doi.org/10.1001/jama.2020.4742PROTOCOLOS, PROTOCOLOS, PROTOCOLOShttp://www.chictr.org.cn/enindex.aspxGautret P, Lagier J-C, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents 2020;56(1):105949. 20 pacientes16 controlesGautret P, Lagier J-C, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents 2020;56(1):105949. Kim AHJ, Sparks JA, Liew JW, et al. A Rush to Judgment? Rapid Reporting and Dissemination of Results and Its Consequences Regarding the Use of Hydroxychloroquine for COVID-19. ANNalsof internal medicine [Internet] 2020;Available from: https://annals.org/aim/fullarticle/2764065/rush-judgment-rapid-reporting-dissemination-results-its-consequences-regarding-use20 pacientes16 controlesKim AHJ, Sparks JA, Liew JW, et al. A Rush to Judgment? Rapid Reporting and Dissemination of Results and Its Consequences Regarding the Use of Hydroxychloroquine for COVID-19. ANNals of internal medicine [Internet] 2020;Available from: https://annals.org/aim/fullarticle/2764065/rush-judgment-rapid-reporting-dissemination-results-its-consequences-regarding-usePearson H. How COVID broke the evidence pipeline. Nature [Internet] 2021 [cited 2022 Nov 16];593(7858):182–5. Available from: https://www.nature.com/articles/d41586-021-01246-xhttps://evidenceaccelerator.org/sites/default/files/2020-10/10.15%20Therapeutics%20Lab%20Meeting%20Summary.pdfOf the 145 registered trials of hydroxychloroquine, for example, 32 have a planned sample size of ≤100, 10 have no control group, and 12 are comparative but non-randomisedhttps://www.bmj.com/content/bmj/369/bmj.m1847.full.pdf1.  Tikkinen KAO, Malekzadeh R, Schlegel M, Rutanen J, Glasziou P. COVID-19 clinical trials: learning from exceptions in the research chaos. Nat Med [Internet] 2020 [cited 2022 Nov 10];26(11):1671–2. Available from: https://www.nature.com/articles/s41591-020-1077-zPearson H. How COVID broke the evidence pipeline. Nature [Internet] 2021 [cited 2022 Nov 16];593(7858):182–5. Available from: https://www.nature.com/articles/d41586-021-01246-xMOTIVACIONES PARA HACER UN ENSAYO CLÍNICO DURANTE UNA PANDEMIAINDIVIDUALES• ACADÉMICAS: Quiero ser autor, si es posible primero o ultimo• DE PRESTIGIO: Que me vean mis colegas• ECONÓMICAS: Mayor en los ensayos de la industria• MÉDICAS: Quiero ofrecer a mi paciente al menos la posibilidad de ser tratado con un fármaco potencialmente eficazCOLECTIVAS• Necesitamos saber, rápidamente, sin un fármaco funcionaMOTIVACIONES PARA HACER UN ENSAYO CLÍNICO DURANTE UNA PANDEMIAINDIVIDUALES• ACADÉMICAS: Quiero ser autor, si es posible primero o ultimo• DE PRESTIGIO: Que me vean mis colegas• ECONÓMICAS: Mayor en los ensayos de la industria• MÉDICAS: Quiero ofrecer a mi paciente al menos la posibilidad de ser tratado con un fármaco potencialmente eficazCOLECTIVAS• Necesitamos saber, rápidamente sin un fármaco funcionaMUCHOS EECC CON MUESTRAS PEQUEÑASNO ADAPTATIVOSPOCOS EECC CON MUESTRAS MUY GRANDESADPTATIVOSPUBLISH OR PERISHVs.DO THE RIGTH CLINICAL TRIAL OR PERISHPREPRINTS, PREPRINTS, PREPRINTSSource https://www.cambridgeblog.org/2019/08/information-overload-in-the-legal-sphere/LUCESSource: https://www.recoverytrial.net/Source: https://www.recoverytrial.net/news/the-recovery-trial-is-two-years-old-today1.  The RECOVERY Collaborative Group. Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. N Engl J Med [Internet] 2020 [cited 2020 Nov 15];NEJMoa2022926. Available from: http://www.nejm.org/doi/10.1056/NEJMoa20229261.  The RECOVERY Collaborative Group. Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. N Engl J Med [Internet] 2020 [cited 2020 Nov 15];NEJMoa2022926. Available from: http://www.nejm.org/doi/10.1056/NEJMoa2022926Source: https://www.nih.gov/research-training/medical-research-initiatives/activSource: https://www.remapcap.org/covid19publicationsSource: .  Diallo A, Trøseid M, Simensen VC, et al. Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group. Clinical Microbiology and Infection [Internet] 2022 [cited 2022 Nov 3];28(1):1–5. Available from: https://linkinghub.elsevier.com/retrieve/pii/S1198743X21006121

¿Lo hicimos todo bien con la COVID-19?: Luces y sombras de la investigación

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¿Lo hicimos todo bien con la COVID-19?: Luces y sombras de la investigación

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