Withdrawn: Low dose radiation therapy for severe COVID-19 pneumonia: a randomized double-blind study

Abstract

Purpose The morbidity and mortality of patients requiring mechanical ventilation for coronavirus disease 2019 (COVID-19) pneumonia is considerable. We studied the use of whole-lung low dose radiation therapy (LDRT) in this patient cohort. Methods and Materials : Patients admitted to the intensive care unit (ICU) and requiring mechanical ventilation for COVID-19 pneumonia were included in this randomized double-blind study. Patients were randomized to 1 Gy whole-lung LDRT or sham irradiation (sham-RT). Treatment group allocation was concealed from patients and ICU clinicians, who treated patients according to the current standard of care. Patients were followed for the primary endpoint of ventilator-free days (VFDs) at day 15 post-intervention. Secondary endpoints included overall survival, as well as changes in oxygenation and inflammatory markers. Results Twenty-two patients were randomized to either whole-lung LDRT or sham-RT between November and December 2020. Patients were generally elderly and comorbid, with a median age of 75 years in both arms. No difference in 15-day VFDs was observed between groups (p = 1.00), with a median of 0 days (range, 0-9) in the LDRT arm, and 0 days (range, 0-13) in the sham-RT arm. Overall survival at 28 days was identical at 63.6% (95%CI, 40.7-99.5%) in both arms (p = 0.69). Apart from a more pronounced reduction in lymphocyte counts following LDRT (p < 0.01), analyses of secondary endpoints revealed no significant differences between the groups. Conclusions Whole-lung LDRT failed to improve clinical outcomes in critically ill patients requiring mechanical ventilation for COVID-19 pneumonia.

Could pulmonary low-dose radiation therapy be an alternative treatment for patients with COVID-19 pneumonia? Preliminary results of a multicenter SEOR-GICOR nonrandomized prospective trial (IPACOVID trial)

“…Beyond the technique used for LD-RT, also debatable because it is far from the quality standards required by modern radiotherapy, the results of the study did not demonstrate the benefit of LD-RT in improving the situation of critically ill patients in the ICU, therefore advising against its use. However, as the authors themselves acknowledge, one of the reasons that could justify the lack of benefit lies in the selection of patients, with an extremely critical condition requiring constant mechanical ventilation [ 29 ]. Probably, like it has been previously commented, LD-RT should be considered in the initial phases of the exacerbated inflammatory response that accompanies the SARS-CoV‑2 infection, the so-called ‘cytokine storm’, in order to maximize the anti-inflammatory effect of dexamethasone.…”

Interim Analysis of Impact of Adding Low Dose Pulmonary Radiotherapy to Moderate COVID-19 Pneumonia Patients: IMpaCt-RT Study

“…However few studies such as that of Papachristofilou et al. demonstrated no benefit of LDRT to improve recovery in critically ill patients requiring MV for COVID-19 pneumonia ( 23 ). Available studies have also indicated the importance of the timing of LDRT to bilateral lung fields stating that there is a small window of opportunity after which radiation may not be adequately effective.…”