This pilot case-control study at Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, India is designed to evaluate the use of low dose radiotherapy (LDRT) in patients with moderate COVID-19 with specific objectives to abrogate the onset of cytokine storm and thus facilitate their early recovery and reduce mortality.
One of the primary attributes to the mortality in coronavirus disease -19 (COVID-19) is acute respiratory distress syndrome (ARDS) induced by severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) mediated cytokine storm (CS).To mitigate the ARDS, an ideal approach would be to diminish the viral load by activating immune cells for CS prevention or to suppress the overactive cytokine-releasing immune cells. The search for ideal pharmaceutical agent/s to take care of SARS-CoV-2 mediated CS is still eluding the clinicians. The only drugs with modest clinical benefit are remdesivir and dexamethasone. The availability of the former is uncertain while an overdependence on steroids could prove counterproductive as evident from increasing incidence of fatal mucormycosis reported in post-COVID patients treated with steroids. The situation for COVID-19 patients successfully treated with steroids is akin to "from frying pan into the fire". Thus, concerted efforts are needed to prevent the onset of CS in COVID-19. This, would directly help to lower the mortality. One of the approaches being recently investigated worldwide, is the use of single low dose radiotherapy (LDRT) of 0.5 - 1.5 Gy to the lungs before the onset of CS in moderately affected COVID-19 patients requiring oxygen supplementation. This crucial window of opportunity needs to be exploited with LDRT to mitigate the onset of the fatal CS. LDRT could thus be a potential game changer in the management of COVID-19. LDRT with its multipronged actions may attenuate immune activation and consequently mitigate the production of pro-inflammatory cytokines. A number of centers have reported encouraging outcomes in pilot studies with LDRT. There has been a significant reduction in oxygen requirement within just 72 hours of LDRT, resulting in reduced hospital stay and deaths. This pilot case-control study at MGIMS is designed to evaluate the use of LDRT in patients with moderate COVID-19 with specific objectives to prevent the onset of CS and thus facilitate their early recovery and reduce mortality.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients in study group will receive LDRT to both lungs by two parallel opposed fields, antero-posterior (AP) and postero-anterior (PA) to deliver a midplane dose of 0.5 Gy in a single fraction. As this dose is very less, doses to the critical structures including heart and lungs would be very low. All the patients will be treated on Telecobalt unit (Theratronics Phoenix, Canada) and not on the linear accelerator to avoid risks to cancer patients on treatment with linear accelerator. CT based plan will not be undertaken for logistic issues and is also not felt to be mandatory for this LDRT. Dose computation would be carried out by manual dose calculation for the Telecobalt unit.
Mahatma Gandhi Institute of Medical Sciences,
Sevāgrām, Maharashtra, India
RECRUITINGMahatma Gandhi Institute of Medical Sciences
Sevāgrām, Maharashtra, India
RECRUITINGNumber of patients dying due to COVID-19
Compare the number of patients whose death could be ascribed to COVID-19 in the two groups
Time frame: 28 days from the date of diagnosis
Mean duration of hospital stay for surviving patients
Compare the mean duration of hospital stay between the patients surviving in study and control groups
Time frame: 28 days from the date of diagnosis / discharge
Mean dose of steroid requirement for surviving patients
Compare the mean total dose of steroid required in between the patients surviving in study and control groups
Time frame: 28 days from the date of diagnosis
Mean time to completely wean off from Oxygen (02) supplementation for surviving patients
Compare the mean time to completely wean off from Oxygen supplementation in patients between the patients surviving in study and control groups
Time frame: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of Interleukin-6 (IL-6)
IL-6 levels in control vs study group patients
Time frame: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of quantitative C reactive protein (CRP)
Quantitative CRP levels in control vs study group patients
Time frame: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of D-Dimer
D-Dimer levels in control vs study group patients
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Time frame: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of Ferritin
Ferritin levels in control vs study group patients
Time frame: 28 days from the date of diagnosis / discharge
Acute pulmonary toxicities that may be attributable to LDRT
Acute pulmonary toxicities as per the Common Terminology Criteria for Adverse Events (CTCAE) version 5
Time frame: 28 days from the date of diagnosis / discharge
Total cost of hospital stay following LDRT for surviving patients
Cost evaluation and comparison between the patients surviving in study and control groups
Time frame: 28 days from the date of diagnosis / discharge