Low dose anti-inflammatory radiotherapy for the treatment of pneumonia by covid-19 : A proposal for a multi-centric prospective trial
Algara, Manuel (Universitat Autònoma de Barcelona. Departament de Medicina)
Arenas, M. (Hospital Universitari Sant Joan de Reus (Tarragona))
Marin, J. (Hospital del Mar (Barcelona, Catalunya))
Vallverdu, I. (Hospital Universitari Sant Joan de Reus (Tarragona))
Fernández-Letón, P.. (Hospital Universitario HM Sanchinarro (Madrid))
Villar, J. (Hospital del Mar (Barcelona, Catalunya))
Fabrer, G. (Hospital Universitari Sant Joan de Reus (Tarragona))
Rubio, C. (Hospital Universitario HM Sanchinarro (Madrid))
Montero, Ángel (Hospital Universitario HM Sanchinarro (Madrid))

Data:	2020
Resum:	COVID-19 is a highly contagious viral infection with high morbidity that is draining health resources. The biggest complication is pneumonia, which has a serious inflammatory component, with no standardized treatment. Low-dose radiation therapy (LD-RT) is non-invasive and has anti-inflammatory effects that can interfere with the inflammatory cascade, thus reducing the severity of associated cytokine release and might be useful in the treatment of respiratory complications caused by COVID-19. This multicentric prospective clinical trial seeks to evaluate the efficacy of bilateral lung LD-RT therapy as a treatment for interstitial pneumonia in patients with COVID-19 for improving respiratory function. This prospective study will have 2 phases: I) an exploratory phase enrolling 10 patients, which will assess the feasibility and efficacy of low-dose lung irradiation, evaluated according to an increase in the PaO2/FiO2 ratio of at least 20% at 48-72 h with respect to the pre-irradiation value. If a minimum efficiency of 30% of the patients is not achieved, the study will not be continued. II) Non-randomized comparative phase in two groups: a control group, which will only receive pharmacological treatment, and an experimental arm with pharmacological treatment and LD-RT. It will include 96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm. The primary end-point will be the efficacy of LD-RT in patients with COVID-19 pneumonia according to an improvement in PaO2/FiO2. Secondary objectives will include the safety of bilateral lung LD-RT, an improvement in the radiology image, overall mortality rates at 15 and 30 days after irradiation and characterizing anti-inflammatory mechanisms of LD-RT by measuring the level of expression of adhesion molecules, anti-inflammatory cytokines and oxidative stress mediators. Trial registration: ClinicalTrial. gov NCT-04380818 .
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	COVID ; Radiotherapy ; Pneumonia
Publicat a:	Clinical and Translational Radiation Oncology, Vol. 24 (june 2020) , p. 29-33, ISSN 2405-6308

DOI: 10.1016/j.ctro.2020.06.005
PMID: 32613089

5 p, 577.8 KB

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