<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/NCT04420390</url>
  </required_header>
  <id_info>
    <org_study_id>LOWRAD-Cov19</org_study_id>
    <nct_id>NCT04420390</nct_id>
  </id_info>
  <brief_title>Low Dose Radiotherapy for COVID-19 Pneumonitis</brief_title>
  <acronym>LOWRAD-Cov19</acronym>
  <official_title>Low Dose Radiotherapy as Antinflammatory Treatment for COVID-19 Pneumonitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital San Carlos, Madrid</source>
  <oversight_info>
    <has_dmc>No</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>
      SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to&#xD;
      its high rate of infection and the high morbidity and mortality.&#xD;
&#xD;
      The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting&#xD;
      the immune response. Low dose radiotherapy (LD-RT) (≤ 100 cGy) induces an anti-inflammatory&#xD;
      response, lowering levels of pro-inflammatory cytokines such as IL-1β or inhibit leukocyte&#xD;
      recruitment. LD-RT has been used historically for the pneumonia treatment reporting a rapid&#xD;
      clinical improvement (within the first week), as well as a reduced mortality (from around 30%&#xD;
      to 10%). Considering these results, LD-RT can potentially afford a therapeutic benefit&#xD;
      against SARS-CoV-2. The study purpose is to evaluate prospectively the safety and efficacy of&#xD;
      LD-RT for SARS-CoV-2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">September 8, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiological response</measure>
    <time_frame>3 days after low dose radiation</time_frame>
    <description>Radiological results: Radiological worsening, improvement or without significant changes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiological response</measure>
    <time_frame>7 days after low dose radiation</time_frame>
    <description>Radiological results: Radiological worsening, improvement or without significant changes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Remission of respiratory symptoms</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Remission of respiratory symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPO2 and PaO2/FiO2</measure>
    <time_frame>7 days</time_frame>
    <description>Time to SPO2&gt;94% or PaO2/FiO2 &gt;350mmHg without oxygen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>Occurrence and grade of CTCAE 5.0 adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>3 months</time_frame>
    <description>Duration of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 month</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin value</measure>
    <time_frame>1 day after low dose radiation</time_frame>
    <description>ferritin value (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin value</measure>
    <time_frame>2 days after low dose radiation</time_frame>
    <description>ferritin value (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin value</measure>
    <time_frame>3 days after low dose radiation</time_frame>
    <description>ferritin value (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood cell count</measure>
    <time_frame>1 day after low dose radiation</time_frame>
    <description>blood cell count (unit/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood cell count</measure>
    <time_frame>2 days after low dose radiation</time_frame>
    <description>blood cell count (unit/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood cell count</measure>
    <time_frame>3 days after low dose radiation</time_frame>
    <description>blood cell count (unit/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>1 day after low dose radiation</time_frame>
    <description>C-reactive protein (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>2 days after low dose radiation</time_frame>
    <description>C-reactive protein (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>3 days after low dose radiation</time_frame>
    <description>C-reactive protein (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer</measure>
    <time_frame>1 day after low dose radiation</time_frame>
    <description>D-dimer (ng/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer</measure>
    <time_frame>2 days after low dose radiation</time_frame>
    <description>D-dimer (ng/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer</measure>
    <time_frame>3 days after low dose radiation</time_frame>
    <description>D-dimer (ng/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDH levels</measure>
    <time_frame>1 day after low dose radiation</time_frame>
    <description>LDH levels (UI/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDH levels</measure>
    <time_frame>2 days after low dose radiation</time_frame>
    <description>LDH levels (UI/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDH levels</measure>
    <time_frame>3 days after low dose radiation</time_frame>
    <description>LDH levels (UI/L)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">41</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Low-dose radiotherapy</description>
    <arm_group_label>Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 60 years.&#xD;
&#xD;
          2. COVID19 + confirmed by PCR.&#xD;
&#xD;
          3. Thoracic imaging study (chest X-ray, chest CT or PET-CT), compatible with lung&#xD;
             involvement.&#xD;
&#xD;
          4. Phase II or lung phase without any improvement with pharmacological treatment.&#xD;
&#xD;
          5. Phase III or hyper-inflammatory phase without any improvement with pharmacological&#xD;
             treatment&#xD;
&#xD;
          6. Poor clinical and functional respiratory evolution: &gt; 30 breaths / minute, SpO2 &lt;93%,&#xD;
             PaO2 / FiO2 &lt;300.&#xD;
&#xD;
          7. D-dimer&gt; 1000 ng / mL or rising, ferritin&gt; 1000 ng / mL, PCR&gt; 10 mg / dL or double&#xD;
             than before.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Severe comorbidities that could hamper the radiation treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Manuel Gonzalo Vazquez Masedo, MD,PhD</last_name>
    <phone>913003000</phone>
    <email>manuelgonzalo.vazquez@salud.madrid.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Servicio de Oncología Radioterápica. Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manuel Gonzalo Vazquez Masedo, MD, PhD</last_name>
      <phone>913003000</phone>
      <email>manuelgonzalo.vazquez@salud.madrid.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Carlos, Madrid</investigator_affiliation>
    <investigator_full_name>Manuel Gonzalo Vázquez Masedo</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Radiotherapy</keyword>
  <keyword>Antiinflammatory</keyword>
  <keyword>Pneumonitis</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>No</sharing_ipd>
  </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/NCT04420390
org study id: LOWRAD-Cov19
nct id: NCT04420390
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to
      its high rate of infection and the high morbidity and mortality.

      The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting
      the immune response. Low dose radiotherapy (LD-RT) (≤ 100 cGy) induces an anti-inflammatory
      response, lowering levels of pro-inflammatory cytokines such as IL-1β or inhibit leukocyte
      recruitment. LD-RT has been used historically for the pneumonia treatment reporting a rapid
      clinical improvement (within the first week), as well as a reduced mortality (from around 30%
      to 10%). Considering these results, LD-RT can potentially afford a therapeutic benefit
      against SARS-CoV-2. The study purpose is to evaluate prospectively the safety and efficacy of
      LD-RT for SARS-CoV-2.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Radiological response
time frame: 3 days after low dose radiation
description: Radiological results: Radiological worsening, improvement or without significant changes
measure: Radiological response
time frame: 7 days after low dose radiation
description: Radiological results: Radiological worsening, improvement or without significant changes
measure: Remission of respiratory symptoms
time frame: up to 6 months
description: Remission of respiratory symptoms
measure: SPO2 and PaO2/FiO2
time frame: 7 days
description: Time to SPO2>94% or PaO2/FiO2 >350mmHg without oxygen
measure: Adverse events
time frame: 1 year
description: Occurrence and grade of CTCAE 5.0 adverse events
measure: Hospitalization
time frame: 3 months
description: Duration of hospitalization
measure: Overall survival
time frame: 1 month
description: Overall survival
measure: Ferritin value
time frame: 1 day after low dose radiation
description: ferritin value (ng/mL)
measure: Ferritin value
time frame: 2 days after low dose radiation
description: ferritin value (ng/mL)
measure: Ferritin value
time frame: 3 days after low dose radiation
description: ferritin value (ng/mL)
measure: blood cell count
time frame: 1 day after low dose radiation
description: blood cell count (unit/L)
measure: blood cell count
time frame: 2 days after low dose radiation
description: blood cell count (unit/L)
measure: blood cell count
time frame: 3 days after low dose radiation
description: blood cell count (unit/L)
measure: C-reactive protein
time frame: 1 day after low dose radiation
description: C-reactive protein (mg/dl)
measure: C-reactive protein
time frame: 2 days after low dose radiation
description: C-reactive protein (mg/dl)
measure: C-reactive protein
time frame: 3 days after low dose radiation
description: C-reactive protein (mg/dl)
measure: D-dimer
time frame: 1 day after low dose radiation
description: D-dimer (ng/ml)
measure: D-dimer
time frame: 2 days after low dose radiation
description: D-dimer (ng/ml)
measure: D-dimer
time frame: 3 days after low dose radiation
description: D-dimer (ng/ml)
measure: LDH levels
time frame: 1 day after low dose radiation
description: LDH levels (UI/L)
measure: LDH levels
time frame: 2 days after low dose radiation
description: LDH levels (UI/L)
measure: LDH levels
time frame: 3 days after low dose radiation
description: LDH levels (UI/L)
arm group label: Radiotherapy
arm group type: Experimental
intervention type: Radiation
intervention name: Radiotherapy
description: Low-dose radiotherapy
arm group label: Radiotherapy
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Manuel Gonzalo Vazquez Masedo, MD,PhD
phone: 913003000
email: manuelgonzalo.vazquez@salud.madrid.org
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital San Carlos, Madrid
investigator full name: Manuel Gonzalo Vázquez Masedo
investigator title: MD, PhD
mesh term: COVID-19
mesh term: Pneumonia
sharing ipd: No