Efficacy of low-dose lung radiotherapy in the management of COVID-19 patients: a randomised, open-label study

Abstract

Objective Evaluate role of low dose radiotherapy (LDRT) in COVID-19 pneumonia. Methods Sixty-five patients 40 years or older tested positive for COVID-19 reverse transcriptase-polymerase chain reaction with mild to moderate acute respiratory distress syndrome (ARDS), were randomised 1:1, from fourth June 2021, to either best standard of care (control arm) according to the Indian Council of Medical Research guidelines or a single dose of Low Dose Radiotherapy (LDRT-0.5Gy) to both lungs along with best standard of care (experimental arm). The primary outcome was either progression to severe disease (PaO2/FiO2 ratio <100 mmHg) within 28 days of randomisation or all-cause mortality at 28 days. If the primary outcome could have been prevented, it was considered “favourable”; if not, it was considered “unfavourable.” Results Thirty-three patients were allocated to experimental arm, thirty-two to control arm. An intention to treat analysis was performed. Unfavourable outcome was seen in 5 (15.2%) patients in experimental arm, vs , 12 (37.5%) patients in control arm, odds of an unfavourable outcome in experimental arm were 0.3, 95% CI 0.09 to 0.97; 2-sided p = 0.04. Four and five patients died in experimental and control arm, respectively. No radiation-induced toxicity was observed. Conclusion LDRT reduced the number of patients with unfavourable outcome at 28 days. Advances in knowledge One of the few randomized studies showing reduced unfavourable outcome in mild to moderate ARDS COVID-19 patients receiving LDRT. CTRI/2021/06/034001, Clinical Trials Registry - India (ICMR-NIMS)