Low-Dose Radiation Therapy in COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Number of patients dying due to COVID-19
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reverse transcription polymerase chain reaction (RT-PCR) / Rapid Ag test positive
- •Signed informed consent
- •Age ≥ 50 yrs
- •Respiratory rate : 25 - 30/min, breathless AND/OR
- •Oxygen saturation by pulse oximetry (SpO2) in 90 - 93% on room air (readings taken after 5 mins of stopping oxygen supplementation)
- •Rising levels of quantitative-CRP and/or D-Dimer and/or Ferritin in 2 consecutive samples taken 24 hours apart
排除标准
- •Patient who have received vaccination for COVID-19 (single / both doses of any approved vaccine)
- •Hemodynamic instability in shock and/or systolic BP < 90mm Hg
- •Septicemia
- •Disseminated intravascular coagulation
- •Requiring ventilation
- •Unable to lie down supine
- •Severe acute respiratory distress with Fraction of inspired oxygen (FiO2) < 100mm Hg
- •Cardiac defibrillator/pacemaker in situ
- •Lymphocyte count < 1 x 106/ml
- •Pregnancy and/or lactating mothers
- •HIV and/or HbsAg positive patients
结局指标
主要结局
Number of patients dying due to COVID-19
时间窗: 28 days from the date of diagnosis
Compare the number of patients whose death could be ascribed to COVID-19 in the two groups
Mean duration of hospital stay for surviving patients
时间窗: 28 days from the date of diagnosis / discharge
Compare the mean duration of hospital stay between the patients surviving in study and control groups
次要结局
- Changes in the biochemical profiles of quantitative C reactive protein (CRP)(28 days from the date of diagnosis / discharge)
- Mean dose of steroid requirement for surviving patients(28 days from the date of diagnosis)
- Changes in the biochemical profiles of Interleukin-6 (IL-6)(28 days from the date of diagnosis / discharge)
- Changes in the biochemical profiles of D-Dimer(28 days from the date of diagnosis / discharge)
- Changes in the biochemical profiles of Ferritin(28 days from the date of diagnosis / discharge)
- Acute pulmonary toxicities that may be attributable to LDRT(28 days from the date of diagnosis / discharge)
- Mean time to completely wean off from Oxygen (02) supplementation for surviving patients(28 days from the date of diagnosis / discharge)
- Total cost of hospital stay following LDRT for surviving patients(28 days from the date of diagnosis / discharge)
研究者
Niloy Ranjan Datta
Director-Professor & Head, Department of Radiotherapy
Mahatma Gandhi Institute of Medical Sciences