Low-Dose Radiation Therapy to Lungs in Moderate COVID-19 Pneumonitis: A Case-Control Pilot Study (LOCORAD)

Mahatma Gandhi Institute of Medical Sciences

Status: Unknown

Conditions: COVID-19; Pneumonia

Treatments: Radiation: Low dose radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04904783

MGIMS/IEC/RADTHP/215/2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Study arm

Active Comparator group

Description:

10 patients of confirmed diagnosis of moderate COVID-19 who fulfil the inclusion criteria and give written informed consent would be in study arm. All patients, belong to both study and control groups would receive the same treatment (oxygen support, steroids, anticoagulant therapy, remdesivir and other supportive therapy) as per the Institute guidelines for management of moderate COVID-19 disease. Only low dose radiotherapy would be added to patients in the study arm.

Treatment:

Radiation: Low dose radiotherapy

Control Arm

No Intervention group

Description:

10 patients of confirmed diagnosis of moderate COVID-19 who fulfil the inclusion criteria and have not given written informed consent would be in study arm. These patients would receive the same treatment (oxygen support, steroids, anticoagulant therapy, remdesivir and other supportive therapy) as per the Institute guidelines for management of moderate COVID-19 disease except low dose radiotherapy.