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 4 June 2021, to either best standard of care (control arm) according to the Indian Council of Medical Research guidelines or a single dose of LDRT (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, 32 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 0.09-0.97; two-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 randomised 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).
