<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/NCT04433949</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000781</org_study_id>
    <secondary_id>NCI-2020-04061</secondary_id>
    <secondary_id>RAD5049-20</secondary_id>
    <secondary_id>P30CA138292</secondary_id>
    <nct_id>NCT04433949</nct_id>
  </id_info>
  <brief_title>Best Supportive Care With or Without Low Dose Whole Lung Radiation Therapy for the Treatment of COVID-19</brief_title>
  <acronym>RESCUE1-19</acronym>
  <official_title>Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19 (RESCUE 1-19): A Randomized Phase III Trial of Best Supportive Care Plus Provider's Choice of Pharmaceutical Treatment With or Without Whole Lung Low-Dose Radiation Therapy (LD-RT) in Hospitalized Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase III trial compares low dose whole lung radiation therapy to best supportive care&#xD;
      plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung&#xD;
      radiation therapy may work better than the current best supportive care and physician's&#xD;
      choice in improving patients' clinical status, the radiographic appearance of their lungs, or&#xD;
      their laboratory blood tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Intubation-free survival (IFS) and (2) time to clinical recovery (TTCR) based on weaning&#xD;
      off supplementary oxygenation or hospital discharge in COVID 19 patients.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To investigate (1) other clinical, (2) radiographic, (3) serologic markers, and (4) immune&#xD;
      marker response to best supportive care plus provider's choice of pharmaceutical treatment&#xD;
      either with or without whole-lung LD-RT&#xD;
&#xD;
      II. Secondary clinical improvements will look at time to hospital discharge, prevention of&#xD;
      ICU admissions, and overall survival.&#xD;
&#xD;
      OUTLINE: Patients are blindly randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive best supportive care plus physician choice of treatment&#xD;
&#xD;
      ARM II: Patients receive best supportive care plus LDRT (experimental arm).&#xD;
&#xD;
      After completion of study, patients are followed up for 14 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Anticipated">May 30, 2024</completion_date>
  <primary_completion_date type="Actual">October 19, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to clinical recovery</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Will be measured by improvements on oxygenation need prior to intervention compared with after intervention and/or hospital discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from ICU admission</measure>
    <time_frame>Up to follow-up day 14 after study start; This may be extended up to 28 days after preplanned interim analysis.</time_frame>
    <description>The rates from both cohort will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Temperature in degrees (F)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Heart rate in beats per minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood pressure</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Systolic blood pressure in mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Oxygen saturation in percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supplemental oxygenation need</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Oxygen saturation in percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Respiratory rate in breaths per minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glasgow Comma Scale from minimum of 3 to maximum of 15.</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Pre and post intervention; Minimum of 3 (poor) to best (15)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance status</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Easter Cooperative Oncology Group (ECOG) Performance Status Scale from 0-5; 0 being best; 5 being dead;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>Up to follow-up day 14 after study start; This may be extended to 28 days after preplanned interim analysis.</time_frame>
    <description>Survival in percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serial chest x-rays severe acute respiratory syndrome (SARS) scoring</measure>
    <time_frame>Up to follow-up day 14 after study start;</time_frame>
    <description>Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on computed tomography (CT) scans pre and post RT</measure>
    <time_frame>Baseline up to follow-up day 14 after study start</time_frame>
    <description>CT scans with volume of consolidation measured in cubic centimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>C-Reactive Protein in mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum chemistry + complete blood cell (CBC) with differential</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Will be summarized descriptively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood gases pH(when available)</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>pH (no unit)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Albumin in gm/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procalcitonin</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Procalcitonin in ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate aminotransferase (AST)</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Asparatate Aminotransferase in units/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatine kinase</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Creatinine in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time (PT)/partial thromboplastin time (PTT)</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Coagulation pathway time in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponin</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Troponin-I in ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lactate</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Lactic Acid in mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NT-pBNP (cardiac injury)</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>B-Natriuretic Peptid in pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gamma-glutamyl transferase (GGT)</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Gamma-glutamyl transferase in units/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Trygliciericdes in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Fibrinogen in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CD8 T cells</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Will be summarized descriptively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CD4 T cells</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Will be summarized descriptively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum antibodies against COVID-19 epitope</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Will be summarized descriptively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDH</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Lactate Dehydrogenase in units/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-Dimer</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>D-Dimer in ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Interleukin-6 in pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myoglobin</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Myoglobin in ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Potassium in mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Ferritin in ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALT</measure>
    <time_frame>Up to follow-up day 14 after study start</time_frame>
    <description>Alanine Aminotransferase in units/L</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Pneumonia</condition>
  <condition>Severe Acute Respiratory Syndrome</condition>
  <condition>Symptomatic COVID-19 Infection Laboratory-Confirmed</condition>
  <arm_group>
    <arm_group_label>Arm I (physician choice)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients get best supportive care + physician choice of treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (LDRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive best supportive care + low dose RT (whole lung)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Practice</intervention_name>
    <description>Receive standard of care</description>
    <arm_group_label>Arm I (physician choice)</arm_group_label>
    <other_name>standard of care</other_name>
    <other_name>standard therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low Dose Radiation Therapy</intervention_name>
    <description>Undergo LDRT</description>
    <arm_group_label>Arm II (LDRT)</arm_group_label>
    <other_name>Low Dose Radiation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be age 50 or over; Not pregnant (will undergo pregnancy testing if below age 55);&#xD;
&#xD;
          -  Have had a positive PCR-based test confirming the diagnosis of COVID-19 within 5 days&#xD;
             (+/-2 day)of study enrollment*&#xD;
&#xD;
          -  Have had clinical signs of severe acute respiratory syndrome or pneumonia (ie.&#xD;
             dyspnea, cough,fever) that primary team feels like patient needs rescuing with&#xD;
             LD-RT.**&#xD;
&#xD;
          -  Have visible bilateral consolidations/ground glass opacities on chest imaging&#xD;
&#xD;
          -  Require supplemental oxygen at the time of enrollment, defined by inability to wean&#xD;
             from supplemental oxygen within 24 hours prior to enrollment.&#xD;
&#xD;
          -  Not require intubation within 12 hours of randomization (ie, not screen fail).&#xD;
             Intubation after enrollment but within 12 hours of randomization will be defined as a&#xD;
             screen failure for both the LD-RT and control cohorts.&#xD;
&#xD;
          -  Be enrolled within 5 days (+/- 2) of first hospitalization for COVID-19. Prior&#xD;
             hospitalization for COVID-19 will be an exclusion criteria (prior ED visits are&#xD;
             permissible).&#xD;
&#xD;
          -  Willingness and ability of the subject to comply with scheduled visits,&#xD;
             protocol-specified laboratory tests, other study procedures, and study restrictions&#xD;
&#xD;
          -  Evidence of a signed informed consent/assent indicating that the subject is aware of&#xD;
             the infectious nature of the disease and has been informed of the procedures to be&#xD;
             followed, potential risks and discomforts, potential benefits, and other pertinent&#xD;
             aspects of study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and/or planned to be pregnant within in next 6 months&#xD;
&#xD;
          -  Age 49 or younger at time of enrollment&#xD;
&#xD;
          -  Prior inpatient hospitalization for COVID-19 (prior emergency department [ED] visits&#xD;
             are not an exclusion criteria)&#xD;
&#xD;
          -  Prior enrollment on a separate COVID-19-related therapeutric trial (subsequent&#xD;
             co-enrollment is permitted for patinets randomized to the control arm).&#xD;
&#xD;
          -  Notably, concurrent use of COVID-directed therapies is no longer an exclusion criteria&#xD;
             for this trial. This includes azithromycin, dexamethasone, remdesevir, convalescent&#xD;
             plasma, or any other COVIDdirected drug therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad K Khan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University Hospital/Winship Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.medrxiv.org/content/10.1101/2020.06.03.20116988v1</url>
    <description>Interim Results from the phase 1, 2 pilot safety trial of LD-RT for COVID</description>
  </link>
  <link>
    <url>https://www.forbes.com/sites/jamesconca/2020/06/12/1st-human-trial-successfully-treated-covid-19-using-low-doses-of-radiation/#34a56312dc69</url>
    <description>Article on Forbes</description>
  </link>
  <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>Dhawan G, Kapoor R, Dhawan R, Singh R, Monga B, Giordano J, Calabrese EJ. Low dose radiation therapy as a potential life saving treatment for COVID-19-induced acute respiratory distress syndrome (ARDS). Radiother Oncol. 2020 Jun;147:212-216. doi: 10.1016/j.radonc.2020.05.002. Epub 2020 May 8.</citation>
    <PMID>32437820</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Mohammad K. Khan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Radiotherapy</keyword>
  <keyword>COVID-19</keyword>
  <keyword>low dose radiotherapy</keyword>
  <keyword>anti-inflammatory</keyword>
  <keyword>cytokine storm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
    <mesh_term>Laboratory Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.</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/NCT04433949
org study id: STUDY00000781
secondary id: NCI-2020-04061
secondary id: RAD5049-20
secondary id: P30CA138292
nct id: NCT04433949
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This phase III trial compares low dose whole lung radiation therapy to best supportive care
      plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung
      radiation therapy may work better than the current best supportive care and physician's
      choice in improving patients' clinical status, the radiographic appearance of their lungs, or
      their laboratory blood tests.
PRIMARY OBJECTIVE:

      I. Intubation-free survival (IFS) and (2) time to clinical recovery (TTCR) based on weaning
      off supplementary oxygenation or hospital discharge in COVID 19 patients.

      SECONDARY OBJECTIVES:

      I. To investigate (1) other clinical, (2) radiographic, (3) serologic markers, and (4) immune
      marker response to best supportive care plus provider's choice of pharmaceutical treatment
      either with or without whole-lung LD-RT

      II. Secondary clinical improvements will look at time to hospital discharge, prevention of
      ICU admissions, and overall survival.

      OUTLINE: Patients are blindly randomized to 1 of 2 arms.

      ARM I: Patients receive best supportive care plus physician choice of treatment

      ARM II: Patients receive best supportive care plus LDRT (experimental arm).

      After completion of study, patients are followed up for 14 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to clinical recovery
time frame: Up to follow-up day 14 after study start
description: Will be measured by improvements on oxygenation need prior to intervention compared with after intervention and/or hospital discharge.
measure: Freedom from ICU admission
time frame: Up to follow-up day 14 after study start; This may be extended up to 28 days after preplanned interim analysis.
description: The rates from both cohort will be reported.
measure: Temperature
time frame: Up to follow-up day 14 after study start
description: Temperature in degrees (F)
measure: Heart rate
time frame: Up to follow-up day 14 after study start
description: Heart rate in beats per minutes
measure: Systolic Blood pressure
time frame: Up to follow-up day 14 after study start
description: Systolic blood pressure in mm Hg
measure: Oxygen saturation
time frame: Up to follow-up day 14 after study start
description: Oxygen saturation in percentage
measure: Supplemental oxygenation need
time frame: Up to follow-up day 14 after study start
description: Oxygen saturation in percentage
measure: Respiratory rate
time frame: Up to follow-up day 14 after study start
description: Respiratory rate in breaths per minute.
measure: Glasgow Comma Scale from minimum of 3 to maximum of 15.
time frame: Up to follow-up day 14 after study start
description: Pre and post intervention; Minimum of 3 (poor) to best (15)
measure: Performance status
time frame: Up to follow-up day 14 after study start
description: Easter Cooperative Oncology Group (ECOG) Performance Status Scale from 0-5; 0 being best; 5 being dead;
measure: Survival
time frame: Up to follow-up day 14 after study start; This may be extended to 28 days after preplanned interim analysis.
description: Survival in percentage
measure: Serial chest x-rays severe acute respiratory syndrome (SARS) scoring
time frame: Up to follow-up day 14 after study start;
description: Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.
measure: Changes on computed tomography (CT) scans pre and post RT
time frame: Baseline up to follow-up day 14 after study start
description: CT scans with volume of consolidation measured in cubic centimeters.
measure: CRP
time frame: Up to follow-up day 14 after study start
description: C-Reactive Protein in mg/L
measure: Serum chemistry + complete blood cell (CBC) with differential
time frame: Up to follow-up day 14 after study start
description: Will be summarized descriptively.
measure: Blood gases pH(when available)
time frame: Up to follow-up day 14 after study start
description: pH (no unit)
measure: Albumin
time frame: Up to follow-up day 14 after study start
description: Albumin in gm/dL
measure: Procalcitonin
time frame: Up to follow-up day 14 after study start
description: Procalcitonin in ng/mL
measure: Aspartate aminotransferase (AST)
time frame: Up to follow-up day 14 after study start
description: Asparatate Aminotransferase in units/L
measure: Creatine kinase
time frame: Up to follow-up day 14 after study start
description: Creatinine in mg/dL
measure: Prothrombin time (PT)/partial thromboplastin time (PTT)
time frame: Up to follow-up day 14 after study start
description: Coagulation pathway time in seconds
measure: Troponin
time frame: Up to follow-up day 14 after study start
description: Troponin-I in ng/mL
measure: Lactate
time frame: Up to follow-up day 14 after study start
description: Lactic Acid in mmol/L
measure: NT-pBNP (cardiac injury)
time frame: Up to follow-up day 14 after study start
description: B-Natriuretic Peptid in pg/mL
measure: Gamma-glutamyl transferase (GGT)
time frame: Up to follow-up day 14 after study start
description: Gamma-glutamyl transferase in units/L
measure: Triglycerides
time frame: Up to follow-up day 14 after study start
description: Trygliciericdes in mg/dL
measure: Fibrinogen
time frame: Up to follow-up day 14 after study start
description: Fibrinogen in mg/dL
measure: Changes in CD8 T cells
time frame: Up to follow-up day 14 after study start
description: Will be summarized descriptively.
measure: Changes in CD4 T cells
time frame: Up to follow-up day 14 after study start
description: Will be summarized descriptively.
measure: Changes in serum antibodies against COVID-19 epitope
time frame: Up to follow-up day 14 after study start
description: Will be summarized descriptively.
measure: LDH
time frame: Up to follow-up day 14 after study start
description: Lactate Dehydrogenase in units/L
measure: D-Dimer
time frame: Up to follow-up day 14 after study start
description: D-Dimer in ng/mL
measure: IL-6
time frame: Up to follow-up day 14 after study start
description: Interleukin-6 in pg/mL
measure: Myoglobin
time frame: Up to follow-up day 14 after study start
description: Myoglobin in ng/mL
measure: Potassium
time frame: Up to follow-up day 14 after study start
description: Potassium in mmol/L
measure: Ferritin
time frame: Up to follow-up day 14 after study start
description: Ferritin in ng/mL
measure: ALT
time frame: Up to follow-up day 14 after study start
description: Alanine Aminotransferase in units/L
arm group label: Arm I (physician choice)
arm group type: Active Comparator
description: Patients get best supportive care + physician choice of treatment
arm group label: Arm II (LDRT)
arm group type: Experimental
description: Patients receive best supportive care + low dose RT (whole lung)
intervention type: Other
intervention name: Best Practice
description: Receive standard of care
arm group label: Arm I (physician choice)
other name: standard of care
other name: standard therapy
intervention type: Radiation
intervention name: Low Dose Radiation Therapy
description: Undergo LDRT
arm group label: Arm II (LDRT)
other name: Low Dose Radiation
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Mohammad K Khan, MD, PhD
role: Principal Investigator
affiliation: Emory University Hospital/Winship Cancer Institute
facility: 
country: United States
url: https://www.medrxiv.org/content/10.1101/2020.06.03.20116988v1
description: Interim Results from the phase 1, 2 pilot safety trial of LD-RT for COVID
url: https://www.forbes.com/sites/jamesconca/2020/06/12/1st-human-trial-successfully-treated-covid-19-using-low-doses-of-radiation/#34a56312dc69
description: Article on Forbes
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: Dhawan G, Kapoor R, Dhawan R, Singh R, Monga B, Giordano J, Calabrese EJ. Low dose radiation therapy as a potential life saving treatment for COVID-19-induced acute respiratory distress syndrome (ARDS). Radiother Oncol. 2020 Jun;147:212-216. doi: 10.1016/j.radonc.2020.05.002. Epub 2020 May 8.
PMID: 32437820
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Mohammad K. Khan
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
mesh term: Laboratory Infection
sharing ipd: No
ipd description: Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.