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Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis

Primary Purpose

COVID-19 Pneumonitis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis
Sponsored by
International Geriatric Radiotherapy Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonitis focused on measuring COVID-19, pneumonitis, whole lung radiotherapy, low dose

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 65 years-old or older patients with proven COVID-19 pneumonitis who may or may not require oxygen

Exclusion Criteria:

  • Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients with COVID-19 pneumonitis who require artificial ventilation or hemodynamically unstable to undergo radiotherapy or consent cannot be obtained either through the patient or power of attorney or patients already enrolled in another clinical trial

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Mortality rate
    Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data

    Secondary Outcome Measures

    Mortality rate
    Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia
    Duration of hospitalization
    Duration of hospitalization for the whole group and different groups with or without oxygen requirement
    Time to recovery
    Ordinal scale at the time of radiotherapy and 28 days later
    Oxygen saturation rate
    Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy
    Patient inflammatory status
    Biomarkers for inflammation such as Interleukin 6 will be monitored and correlated with ordinal scale at different times following radiotherapy

    Full Information

    First Posted
    July 29, 2020
    Last Updated
    July 29, 2020
    Sponsor
    International Geriatric Radiotherapy Group
    Collaborators
    Brigitta G. Baumert
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04493294
    Brief Title
    Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis
    Official Title
    Low Dose Whole Lung Radiotherapy for Older Patients With Coronavirus 19 Disease (COVID-19) Pneumonitis: Practical Protocol by the International Geriatric Radiotherapy Group
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2020 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    International Geriatric Radiotherapy Group
    Collaborators
    Brigitta G. Baumert

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis
    Detailed Description
    Background: Coronavirus disease 19 (COVID-19) carry a high mortality rate among older patients and minorities such as ethnic Africans and Latinos. The chronic baseline systemic inflammation of older patients and minorities may make them more vulnerable to the cytokines storm generated by the viral infection in addition to preexisting co-morbidity. Even though multiple organs failure result from the cytokine storm, pneumonia and respiratory failure often lead to death. Low dose whole lung radiotherapy (LDWLRT) may modulate the inflammatory response and may decrease the need for artificial ventilation, thus improving mortality rate. Methods: A phase I-II prospective trials enrolling 500 patients, 65 years old or older from 26 countries will be conducted to investigate the impact of LDWLRT on mortality rate of COVID-19 patients. The patients who will be selected would have developed pneumonias but did not require artificial ventilation. These patients will be followed for a year after receiving this treatment. Their physical activities will be monitored through the ordinal scale and will be correlated with their cytokines status and oxygen saturation rate to assess the impact of the residual inflammation on their daily life. Mortality rates between different ethnic group will be compared and correlated with their cytokines response to the virus and number of co-morbidities. Discussion and importance of the study: We postulate that LDWLRT may improve survival rates of all patients by preventing the need for artificial ventilation which is associated with a high mortality. The inflammatory response between different ethnic groups before and following radiotherapy will be valuable to serve as baseline for future prospective pandemic studies as it has not been reported before.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19 Pneumonitis
    Keywords
    COVID-19, pneumonitis, whole lung radiotherapy, low dose

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Using low dose whole lung radiotherapy to older patients who develop COVID-19 pneumonitis to improve their survival compared to historical data
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Radiation
    Intervention Name(s)
    Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis
    Intervention Description
    Low dose whole lung radiotherapy may decrease the cytokines storm related to the viral infection and may improve survival by decreasing the need for artificial ventilation
    Primary Outcome Measure Information:
    Title
    Mortality rate
    Description
    Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Mortality rate
    Description
    Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia
    Time Frame
    One year
    Title
    Duration of hospitalization
    Description
    Duration of hospitalization for the whole group and different groups with or without oxygen requirement
    Time Frame
    One year
    Title
    Time to recovery
    Description
    Ordinal scale at the time of radiotherapy and 28 days later
    Time Frame
    One month
    Title
    Oxygen saturation rate
    Description
    Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy
    Time Frame
    One year
    Title
    Patient inflammatory status
    Description
    Biomarkers for inflammation such as Interleukin 6 will be monitored and correlated with ordinal scale at different times following radiotherapy
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 65 years-old or older patients with proven COVID-19 pneumonitis who may or may not require oxygen Exclusion Criteria: Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients with COVID-19 pneumonitis who require artificial ventilation or hemodynamically unstable to undergo radiotherapy or consent cannot be obtained either through the patient or power of attorney or patients already enrolled in another clinical trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nam p Nguyen, MD
    Phone
    202-865-1421
    Email
    namphong.nguyen@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brigitta G Baumert, M.D.Ph.D
    Organizational Affiliation
    Institute of Radiation Oncology, Cantonal hospital Graubuenden, Chur, Switzerland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    There are over 40 people involved in the study, we need their approval before data sharing
    Citations:
    PubMed Identifier
    32373721
    Citation
    Lara PC, Burgos J, Macias D. Low dose lung radiotherapy for COVID-19 pneumonia. The rationale for a cost-effective anti-inflammatory treatment. Clin Transl Radiat Oncol. 2020 Apr 25;23:27-29. doi: 10.1016/j.ctro.2020.04.006. eCollection 2020 Jul.
    Results Reference
    background
    PubMed Identifier
    32489696
    Citation
    Lara PC, Nguyen NP, Macias-Verde D, Burgos-Burgos J, Arenas M, Zamagni A, Vinh-Hung V, Baumert BG, Motta M, Myint AS, Bonet M, Popescu T, Vuong T, Appalanaido GK, Trigo L, Karlsson U, Thariat J. Whole-lung Low Dose Irradiation for SARS-Cov2 Induced Pneumonia in the Geriatric Population: An Old Effective Treatment for a New Disease? Recommendation of the International Geriatric Radiotherapy Group. Aging Dis. 2020 May 9;11(3):489-493. doi: 10.14336/AD.2020.0506. eCollection 2020 May.
    Results Reference
    background

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    Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis

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