Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

Overview

This phase II trial studies low-dose radiation therapy as a treatment for patients with severe COVID-19 pneumonia to improve clinical status.

Full Title of Study: “Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Multicenter Phase II Prospective Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2024

Detailed Description

PRIMARY OBJECTIVE: I. To compare treatment of severe COVID-19 pneumonia between supportive care and standard of care drug therapies versus supportive care and standard of care drug therapies plus low-dose, whole-lung radiation therapy OUTLINE: Patients undergo 1.5Gy of single low-dose radiation therapy. After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.

Interventions

  • Radiation: Low-Dose Radiation Therapy
    • 1.5Gy single treatment of whole-lung radiation therapy

Arms, Groups and Cohorts

  • Experimental: Treatment group
    • supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) plus 1.5Gy single treatment of whole-lung radiation therapy
  • No Intervention: Control group
    • supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.)

Clinical Trial Outcome Measures

Primary Measures

  • Clinical improvement
    • Time Frame: 28 days after radiation therapy
    • improvement of oxygen saturation

Secondary Measures

  • Temperature
    • Time Frame: 28 days after radiation therapy
    • Temperature in degrees (˚C)
  • Heart Rate
    • Time Frame: 28 days after radiation therapy
    • Heart rate in beats per minutes
  • Systolic blood pressure
    • Time Frame: 28 days after radiation therapy
    • Systolic blood pressure in mm Hg Systolic blood pressure in mm Hg
  • Respirations Respirations Respirations Respirations Respirations Respirations
    • Time Frame: 28 days after radiation therapy
    • Respiratory rate in breaths per minute
  • FiO2
    • Time Frame: 28 days after radiation therapy
    • Fi02 in percentage
  • PEEP Tidal volume Tidal volume
    • Time Frame: 28 days after radiation therapy
    • Positive end expiratory pressure (PEEP) in cm H20
  • Overall survival Overall survival
    • Time Frame: 28 days after radiation therapy
    • Survival in percentage
  • Chest CT can
    • Time Frame: 28 days after radiation therapy
    • CT scans with volume of consolidation measured in cubic centimeters
  • Blood Test
    • Time Frame: 28 days after radiation therapy
  • Urine Test
    • Time Frame: 28 days after radiation therapy

Participating in This Clinical Trial

Inclusion Criteria

1. Have had a positive test confirming the diagnosis of COVID-19; 2. Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment); 3. Have visible consolidations/ground glass opacities on chest x-ray or computed tomography; 4. Have been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy; 5. They voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form. Exclusion Criteria:

1. Have received chest radiotherapy before 2. Bacteria, fungi and other infections other than novel coronavirus infection; 3. Combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic and endocrine system or immune system diseases (the upper limit of liver function ALT and AST> normal reference value, the upper limit of Scr> normal reference value, poor blood glucose control); 4. Mental retardation, mental disorders; 5. Planned pregnancy, pregnancy, lactation women and during the trial; 6. Allergy constitution or allergy to the drug ingredients and excipients of this test; 7. Participated in other clinical trials in the recent 1 month; 8. The Investigator does not considered appropriate to participate in this clinical trial.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu Cancer Institute & Hospital
  • Collaborator
    • Nanjing Chest Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. He Xia, Vice President – Jiangsu Cancer Institute & Hospital
  • Overall Contact(s)
    • Lirong Wu, M.D, Ph.D, 13701588737, wulirong126@126.com

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