<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/NCT04414293</url>
  </required_header>
  <id_info>
    <org_study_id>FHPCS-20-001</org_study_id>
    <nct_id>NCT04414293</nct_id>
  </id_info>
  <brief_title>Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis</brief_title>
  <acronym>COVRTE-19</acronym>
  <official_title>Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Provincial de Castellon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Provincial de Castellon</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The administration of low-dose lung irradiation produces anti-inflammatory effects that will&#xD;
      decrease the pulmonary inflammatory response.&#xD;
&#xD;
      The present study will evaluate the efficacy of treatment with low-dose pulmonary&#xD;
      radiotherapy added to standard support therapy, in hospitalized patients with respiratory&#xD;
      symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional&#xD;
      medical therapy and are not subsidiaries of ICU&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The WHO has officially confirmed that: &quot;Currently, there is no specific pharmacological&#xD;
      available treatment for COVID-19&quot;.&#xD;
&#xD;
      Beyond vital support, there are not currently treatment options for Coronavirus disease&#xD;
      (COVID-19) and related pneumonia, the infection caused by Severe Acute Respiratory Syndrome&#xD;
      Coronavirus 2 (SARS-CoV-2). Pulmonary irradiation is an option for the treatment of COVID-19&#xD;
      pneumonia and could be available quickly and with a duration of about 15 minutes of&#xD;
      treatment.&#xD;
&#xD;
      Thoracic irradiation therapy at very low doses (0.5-1.0 Gy) dates back to the 1920s and was&#xD;
      the only effective mean to treat certain infectious and inflammatory diseases prior to the&#xD;
      development of antimicrobial therapies in the 1940s.&#xD;
&#xD;
      The goal is to replicate low-dose radiation therapy, just as it was used 80 years ago for&#xD;
      viral pneumonia with great success. It will be administered for a new disease, pneumonia&#xD;
      caused by COVID-19, for which there is no cure and many people are dying, mainly from severe&#xD;
      acute respiratory syndrome leading to very severe hypoxemic acute respiratory failure&#xD;
      refractory to treatment.&#xD;
&#xD;
      This therapy is expected to remedy acute respiratory syndrome by reducing inflammation, and&#xD;
      it also has a low risk of side effects and toxicities, given the low doses received, more&#xD;
      than one hundred times lower, compared to the usual radiotherapy used to tumor treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</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>blood oxygen saturation level</measure>
    <time_frame>48 hours</time_frame>
    <description>Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Torax X-ray</measure>
    <time_frame>48 hours</time_frame>
    <description>radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>2 months</time_frame>
    <description>number of days of hospital stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days free of assisted mechanical respiration</measure>
    <time_frame>3 month</time_frame>
    <description>Number of days free of assisted mechanical respiration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>3 months</time_frame>
    <description>number of deaths</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">41</enrollment>
  <condition>COVID</condition>
  <condition>Pneumonia, Viral</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the patients will be treated with low dose lung radiation</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Lung Low Dose Radiation</intervention_name>
    <description>The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 65 years old&#xD;
&#xD;
          -  Hospitalized with COVID-19 positive not subsidiary of ICU with severe disease defined&#xD;
             by the presence of ALL the following characteristics:&#xD;
&#xD;
               -  Presence of unilateral or bilateral pulmonary infiltrates in chest X-ray or&#xD;
                  computed tomography (CT).&#xD;
&#xD;
               -  Acute respiratory failure expressed by PaO2 / FIO2 &lt;300.&#xD;
&#xD;
               -  Lymphopenia ≤0.8 × 109 / L (800 lymphocytes / ml).&#xD;
&#xD;
               -  Patients with ≤8 days from the onset of symptoms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not consent to participate&#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>Carlos Ferrer Albiach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Provincial de Castellon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francisco Garcia Piñón, MSc</last_name>
    <phone>964354458</phone>
    <email>francisco.garpi@hospitalprovincial.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Provincial de Castellon</name>
      <address>
        <city>Castellón De La Plana</city>
        <state>Castellon</state>
        <zip>12002</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>FRANCISCO GARCIA PINON, MSc</last_name>
      <phone>964354458</phone>
    </contact>
    <investigator>
      <last_name>Carlos Ferrer Albiach, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 12, 2021</last_update_submitted>
  <last_update_submitted_qc>February 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Provincial de Castellon</investigator_affiliation>
    <investigator_full_name>Carlos Ferrer Albiach</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>covid-19 pneumonia</keyword>
  <keyword>Low dose Radiotherapy</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>
    <mesh_term>Pneumonia, Viral</mesh_term>
  </condition_browse>
  <!-- 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/NCT04414293
org study id: FHPCS-20-001
nct id: NCT04414293
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The administration of low-dose lung irradiation produces anti-inflammatory effects that will
      decrease the pulmonary inflammatory response.

      The present study will evaluate the efficacy of treatment with low-dose pulmonary
      radiotherapy added to standard support therapy, in hospitalized patients with respiratory
      symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional
      medical therapy and are not subsidiaries of ICU
The WHO has officially confirmed that: "Currently, there is no specific pharmacological
      available treatment for COVID-19".

      Beyond vital support, there are not currently treatment options for Coronavirus disease
      (COVID-19) and related pneumonia, the infection caused by Severe Acute Respiratory Syndrome
      Coronavirus 2 (SARS-CoV-2). Pulmonary irradiation is an option for the treatment of COVID-19
      pneumonia and could be available quickly and with a duration of about 15 minutes of
      treatment.

      Thoracic irradiation therapy at very low doses (0.5-1.0 Gy) dates back to the 1920s and was
      the only effective mean to treat certain infectious and inflammatory diseases prior to the
      development of antimicrobial therapies in the 1940s.

      The goal is to replicate low-dose radiation therapy, just as it was used 80 years ago for
      viral pneumonia with great success. It will be administered for a new disease, pneumonia
      caused by COVID-19, for which there is no cure and many people are dying, mainly from severe
      acute respiratory syndrome leading to very severe hypoxemic acute respiratory failure
      refractory to treatment.

      This therapy is expected to remedy acute respiratory syndrome by reducing inflammation, and
      it also has a low risk of side effects and toxicities, given the low doses received, more
      than one hundred times lower, compared to the usual radiotherapy used to tumor treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: blood oxygen saturation level
time frame: 48 hours
description: Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels
measure: Torax X-ray
time frame: 48 hours
description: radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.
measure: Hospitalization
time frame: 2 months
description: number of days of hospital stay.
measure: days free of assisted mechanical respiration
time frame: 3 month
description: Number of days free of assisted mechanical respiration.
measure: Mortality
time frame: 3 months
description: number of deaths
arm group label: Treatment
arm group type: Experimental
description: All the patients will be treated with low dose lung radiation
intervention type: Radiation
intervention name: Lung Low Dose Radiation
description: The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.
arm group label: Treatment
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos Ferrer Albiach, MD
role: Principal Investigator
affiliation: Hospital Provincial de Castellon
last name: Francisco Garcia Piñón, MSc
phone: 964354458
email: francisco.garpi@hospitalprovincial.es
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Provincial de Castellon
investigator full name: Carlos Ferrer Albiach
investigator title: MD
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Pneumonia, Viral