BENGALURU: After studies by the All India Institute of Medical Sciences (AIIMS) and others done abroad, clinical trials for low dose radiation therapy (LDRT) on COVID-19 patients are set to begin at HCG Cancer Hospital in Bengaluru. Radiation refers to X-ray treatment.
The trials for LDRT as a possible treatment strategy for COVID-19 viral pneumonia have been registered with HCG Hospitals Institutional Scientific and Ethics Committee. It is said to hold promise in modulating the unregulated immune response that leads to fatal outcomes in progressive COVID-19 pneumonia. While in cancer patients, 60-70 gray (Gy) of radiation is given, here it will be 0.5 Gy.
"It will suppress the cytokine storm and improve dependency on oxygen, mechanical ventilation and prevent lung damage. It could be an important treatment option for COVID-19 associated acute respiratory distress syndrome (ARDS), for those patients who are moderate to critical and for whom other treatment options are unsuccessful or unavailable. It can be used in combinations with other standard approved therapies like steroids, antiviral medication and oxygen," said Dr Lohit Reddy, Consultant Radiation Oncologist, Clinical lead-Radiomics and AI in cancer at HCG Hospital.
The therapy will down regulate the cytokine storm which is a hyper inflammatory state. The toxicity and long term side effects will be less in LDRT as compared to the standard dose used for oncology radiation.
However, clinical trials have to tread with caution and learn from history in choosing the right patients and instituting treatment in the golden window of early progression of symptoms where response is most expected. Larger clinical trials will have to be done to validate its effectiveness, short term and long term risks and mechanism of low dosing.
This trial will be done on a minimum of 10 patients, over a period of 1 to 1.5 months, in collaboration with the hospital's branch in Hubballi.
"The trials done abroad have shown that the treatment is beneficial. Phase-3 trials are yet to conclude in other places. Based on the results of this experiment, the health ministry can approve it as standard of care," Dr Reddy added.
In the AIIMS study done last year, a total of 10 patients were recruited and treated from June to August 2020.
"One patient showed clinical deterioration and had to be intubated. He finally succumbed to ARDS on day 24. Rest 9 patients had completed clinical response and finally discharged from the hospital after their COVID test was negative. Results of our study (90% response rate) suggest the feasibility and clinical effectiveness of LDRT in COVID-19 patients having moderate to severe risk disease. This mandates a randomized controlled trial to establish the clinical efficacy of LDRT in COVID-19 pneumonia," the AIIMS study read.