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

NCT ID: NCT04904783

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-12-31

Brief Summary

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.

Detailed 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.

Conditions

COVID-19; Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

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.

Group Type: ACTIVE_COMPARATOR

Low dose radiotherapy

Intervention Type: RADIATION

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.

Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low dose radiotherapy

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahatma Gandhi Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Niloy Ranjan Datta

Director-Professor & Head, Department of Radiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niloy R Datta, MD,DNB

Role: PRINCIPAL_INVESTIGATOR

Dept of Radiotherapy, Mahatma Gandhi Institute of Medical Sciences, India

Locations

Mahatma Gandhi Institute of Medical Sciences,

Sevāgrām, Maharashtra, India

Site Status: RECRUITING

Mahatma Gandhi Institute of Medical Sciences

Sevāgrām, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Niloy R Datta, MD,DNB

Role: CONTACT

niloydatta@mgims.ac.in

+91- 9717388117

Jyoti Jain, MD, PhD

Role: CONTACT

jyotijain@mgims.ac.in

+91-9850517839

Facility Contacts

Niloy R Datta, MD, DNB

Role: primary

niloydatta@magims.ac.in

+919717388117

Jyoti Jain, MD, PhD

Role: backup

jyotijain@mgims.ac.in

+919850517839

Niloy R Datta, MD, DNB

Role: primary

niloydatta@magims.ac.in

+919717388117

Jyoti Jain, MD, PhD

Role: backup

jyotijain@mgims.ac.in

+919850517839

Other Identifiers

MGIMS/IEC/RADTHP/215/2021

Identifier Type: -

Identifier Source: org_study_id