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

NCT04904783 | Unknown

• 1 other identifier: MGIMS/IEC/RADTHP/215/2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19; Pneumonia

Keywords

COVID-19; Pneumonia; Low dose radiotherapy; Cytokine storm

Outcome Measures

Primary Outcomes (2)

• Number of patients dying due to COVID-19

  Compare the number of patients whose death could be ascribed to COVID-19 in the two groups

  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

  28 days from the date of diagnosis / discharge

Secondary Outcomes (8)

• Mean dose of steroid requirement for surviving patients

  28 days from the date of diagnosis

• Mean time to completely wean off from Oxygen (02) supplementation for surviving patients

  28 days from the date of diagnosis / discharge

• Changes in the biochemical profiles of Interleukin-6 (IL-6)

  28 days from the date of diagnosis / discharge

• Changes in the biochemical profiles of quantitative C reactive protein (CRP)

  28 days from the date of diagnosis / discharge

• Changes in the biochemical profiles of D-Dimer

  28 days from the date of diagnosis / discharge

Study Arms (2)

Study arm

ACTIVE COMPARATOR

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.

Radiation: Low dose radiotherapy

Control Arm

NO INTERVENTION

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.

Interventions

Low dose radiotherapy 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.

Study arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahatma Gandhi Institute of Medical Sciences: lead

Study Sites (2)

Mahatma Gandhi Institute of Medical Sciences,

Sevāgrām, Maharashtra, 442102, India

RECRUITING

Mahatma Gandhi Institute of Medical Sciences

Sevāgrām, Maharashtra, 442102, India

RECRUITING

MeSH Terms

Conditions

COVID-19; Pneumonia; Cytokine Release Syndrome

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Niloy R Datta, MD,DNB

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niloy R Datta, MD,DNB

CONTACT

+91- 9717388117; niloydatta@mgims.ac.in

Jyoti Jain, MD, PhD

CONTACT

+91-9850517839; jyotijain@mgims.ac.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director-Professor & Head, Department of Radiotherapy

Model Details: To explore the role of low dose pulmonary radiotherapy (LDRT) in moderate disease category of COVID-19 patients with pneumonitis in terms of the following primary and secondary objectives. The outcome of LDRT in a pilot group of 10 patients (Study group) would be compared with another 10 patients (Control group) who have not given consent for LDRT and/or would not able to be able to lie down still for the entire treatment duration in the radiotherapy unit. This is not a randomized but a case-control study.

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 27, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months from date of publication of the final results.
• Access Criteria: On request to Principal investigator

Locations

IN (2)