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Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

Primary Purpose

COVID-19 Pneumonia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Low-Dose Radiation Therapy
Sponsored by
Jiangsu Cancer Institute & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring COVID-19, Radiation Therapy, Pneumonia

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have had a positive test confirming the diagnosis of COVID-19; Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment); Have visible consolidations/ground glass opacities on chest x-ray or computed tomography; Have been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy; They voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form. Exclusion Criteria: Have received chest radiotherapy before Bacteria, fungi and other infections other than novel coronavirus infection; 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); Mental retardation, mental disorders; Planned pregnancy, pregnancy, lactation women and during the trial; Allergy constitution or allergy to the drug ingredients and excipients of this test; Participated in other clinical trials in the recent 1 month; The Investigator does not considered appropriate to participate in this clinical trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment group

    Control group

    Arm Description

    supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) plus 1.5Gy single treatment of whole-lung radiation therapy

    supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.)

    Outcomes

    Primary Outcome Measures

    Clinical improvement
    improvement of oxygen saturation in percentage

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 20, 2023
    Last Updated
    January 22, 2023
    Sponsor
    Jiangsu Cancer Institute & Hospital
    Collaborators
    Nanjing Chest Hospital, The Affiliated BenQ Hospital of Nanjing Medical University, Central South University, Zhongda Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05694962
    Brief Title
    Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia
    Official Title
    Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Multicenter Phase II Prospective Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Jiangsu Cancer Institute & Hospital
    Collaborators
    Nanjing Chest Hospital, The Affiliated BenQ Hospital of Nanjing Medical University, Central South University, Zhongda Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19 Pneumonia
    Keywords
    COVID-19, Radiation Therapy, Pneumonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) plus 1.5Gy single treatment of whole-lung radiation therapy
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.)
    Intervention Type
    Radiation
    Intervention Name(s)
    Low-Dose Radiation Therapy
    Intervention Description
    1.5Gy single treatment of whole-lung radiation therapy
    Primary Outcome Measure Information:
    Title
    Clinical improvement
    Description
    improvement of oxygen saturation in percentage
    Time Frame
    28 days after radiation therapy
    Secondary Outcome Measure Information:
    Title
    Temperature
    Description
    Temperature in degrees (˚C)
    Time Frame
    28 days after radiation therapy
    Title
    Heart Rate
    Description
    Heart rate in beats per minutes
    Time Frame
    28 days after radiation therapy
    Title
    Systolic blood pressure
    Description
    Systolic blood pressure in mm Hg Systolic blood pressure in mm Hg
    Time Frame
    28 days after radiation therapy
    Title
    Respirations Respirations Respirations Respirations Respirations Respirations
    Description
    Respiratory rate in breaths per minute
    Time Frame
    28 days after radiation therapy
    Title
    FiO2
    Description
    Fi02 in percentage
    Time Frame
    28 days after radiation therapy
    Title
    PEEP Tidal volume Tidal volume
    Description
    Positive end expiratory pressure (PEEP) in cm H20
    Time Frame
    28 days after radiation therapy
    Title
    Overall survival Overall survival
    Description
    Survival in percentage
    Time Frame
    28 days after radiation therapy
    Title
    Chest CT can
    Description
    CT scans with volume of consolidation measured in cubic centimeters
    Time Frame
    28 days after radiation therapy
    Title
    Blood Test
    Time Frame
    28 days after radiation therapy
    Title
    Urine Test
    Time Frame
    28 days after radiation therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have had a positive test confirming the diagnosis of COVID-19; Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment); Have visible consolidations/ground glass opacities on chest x-ray or computed tomography; Have been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy; They voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form. Exclusion Criteria: Have received chest radiotherapy before Bacteria, fungi and other infections other than novel coronavirus infection; 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); Mental retardation, mental disorders; Planned pregnancy, pregnancy, lactation women and during the trial; Allergy constitution or allergy to the drug ingredients and excipients of this test; Participated in other clinical trials in the recent 1 month; The Investigator does not considered appropriate to participate in this clinical trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lirong Wu, M.D, Ph.D
    Phone
    13701588737
    Email
    wulirong126@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xia He, M.D, Ph.D
    Phone
    +86-25-83283563
    Email
    hexiabm@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

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