Low dose anti-inflammatory radiotherapy for the treatment of pneumonia by covid-19: A proposal for a multi-centric prospective trial
Fecha
2020Autor
Algara, M.
Arenas, M.
Marin, J.
Vallverdu, I.
Fernandez-Letón, P.
Villar, J.
Fabrer, G.
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Resumen
Background: 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.
Study design and methods: 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 antiinflammatory mechanisms of LD-RT by measuring the level of expression of adhesion molecules, antiinflammatory cytokines and oxidative stress mediators.
Palabras clave
COVID; Radiotherapy; PneumoniaEnlace al recurso
https://doi.org/10.1016/j.ctro.2020.06.005Colecciones
- Año 2020 [153]
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