<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493294</url>
  </required_header>
  <id_info>
    <org_study_id>IGRG01</org_study_id>
    <nct_id>NCT04493294</nct_id>
  </id_info>
  <brief_title>Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Geriatric Radiotherapy Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brigitta G. Baumert</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Geriatric Radiotherapy Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low dose whole lung radiotherapy may improve survival of older patients with COVID-19&#xD;
      pneumonitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Coronavirus disease 19 (COVID-19) carry a high mortality rate among older&#xD;
      patients and minorities such as ethnic Africans and Latinos. The chronic baseline systemic&#xD;
      inflammation of older patients and minorities may make them more vulnerable to the cytokines&#xD;
      storm generated by the viral infection in addition to preexisting co-morbidity.&#xD;
&#xD;
      Even though multiple organs failure result from the cytokine storm, pneumonia and respiratory&#xD;
      failure often lead to death. Low dose whole lung radiotherapy (LDWLRT) may modulate the&#xD;
      inflammatory response and may decrease the need for artificial ventilation, thus improving&#xD;
      mortality rate.&#xD;
&#xD;
      Methods: A phase I-II prospective trials enrolling 500 patients, 65 years old or older from&#xD;
      26 countries will be conducted to investigate the impact of LDWLRT on mortality rate of&#xD;
      COVID-19 patients. The patients who will be selected would have developed pneumonias but did&#xD;
      not require artificial ventilation. These patients will be followed for a year after&#xD;
      receiving this treatment. Their physical activities will be monitored through the ordinal&#xD;
      scale and will be correlated with their cytokines status and oxygen saturation rate to assess&#xD;
      the impact of the residual inflammation on their daily life. Mortality rates between&#xD;
      different ethnic group will be compared and correlated with their cytokines response to the&#xD;
      virus and number of co-morbidities.&#xD;
&#xD;
      Discussion and importance of the study: We postulate that LDWLRT may improve survival rates&#xD;
      of all patients by preventing the need for artificial ventilation which is associated with a&#xD;
      high mortality. The inflammatory response between different ethnic groups before and&#xD;
      following radiotherapy will be valuable to serve as baseline for future prospective pandemic&#xD;
      studies as it has not been reported before.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Using low dose whole lung radiotherapy to older patients who develop COVID-19 pneumonitis to improve their survival compared to historical data</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>One year</time_frame>
    <description>Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>One year</time_frame>
    <description>Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>One year</time_frame>
    <description>Duration of hospitalization for the whole group and different groups with or without oxygen requirement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recovery</measure>
    <time_frame>One month</time_frame>
    <description>Ordinal scale at the time of radiotherapy and 28 days later</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation rate</measure>
    <time_frame>One year</time_frame>
    <description>Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient inflammatory status</measure>
    <time_frame>One year</time_frame>
    <description>Biomarkers for inflammation such as Interleukin 6 will be monitored and correlated with ordinal scale at different times following radiotherapy</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>COVID-19 Pneumonitis</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis</intervention_name>
    <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</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  65 years-old or older patients with proven COVID-19 pneumonitis who may or may not&#xD;
             require oxygen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients&#xD;
             with COVID-19 pneumonitis who require artificial ventilation or hemodynamically&#xD;
             unstable to undergo radiotherapy or consent cannot be obtained either through the&#xD;
             patient or power of attorney or patients already enrolled in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brigitta G Baumert, M.D.Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Radiation Oncology, Cantonal hospital Graubuenden, Chur, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nam p Nguyen, MD</last_name>
    <phone>202-865-1421</phone>
    <email>namphong.nguyen@yahoo.com</email>
  </overall_contact>
  <reference>
    <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.</citation>
    <PMID>32373721</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>32489696</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>International Geriatric Radiotherapy Group</investigator_affiliation>
    <investigator_full_name>Nam Nguyen</investigator_full_name>
    <investigator_title>President</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>pneumonitis</keyword>
  <keyword>whole lung radiotherapy</keyword>
  <keyword>low dose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>There are over 40 people involved in the study, we need their approval before data sharing</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493294
org study id: IGRG01
nct id: NCT04493294
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Low dose whole lung radiotherapy may improve survival of older patients with COVID-19
      pneumonitis
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Using low dose whole lung radiotherapy to older patients who develop COVID-19 pneumonitis to improve their survival compared to historical data
primary purpose: Treatment
masking: None (Open Label)
measure: Mortality rate
time frame: One year
description: Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data
measure: Mortality rate
time frame: One year
description: Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia
measure: Duration of hospitalization
time frame: One year
description: Duration of hospitalization for the whole group and different groups with or without oxygen requirement
measure: Time to recovery
time frame: One month
description: Ordinal scale at the time of radiotherapy and 28 days later
measure: Oxygen saturation rate
time frame: One year
description: Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy
measure: Patient inflammatory status
time frame: One year
description: Biomarkers for inflammation such as Interleukin 6 will be monitored and correlated with ordinal scale at different times following radiotherapy
intervention type: Radiation
intervention name: Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis
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
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Brigitta G Baumert, M.D.Ph.D
role: Principal Investigator
affiliation: Institute of Radiation Oncology, Cantonal hospital Graubuenden, Chur, Switzerland
last name: Nam p Nguyen, MD
phone: 202-865-1421
email: namphong.nguyen@yahoo.com
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.
PMID: 32373721
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.
PMID: 32489696
responsible party type: Principal Investigator
investigator affiliation: International Geriatric Radiotherapy Group
investigator full name: Nam Nguyen
investigator title: President
mesh term: COVID-19
mesh term: Pneumonia
sharing ipd: Undecided
ipd description: There are over 40 people involved in the study, we need their approval before data sharing