<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/NCT04444531</url>
  </required_header>
  <id_info>
    <org_study_id>COVID Networking group</org_study_id>
    <nct_id>NCT04444531</nct_id>
  </id_info>
  <brief_title>Ozone Therapy and Coronavirus Disease of 2019 (COVID-19) Pneumonia</brief_title>
  <official_title>Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta</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>
      The objective is to determine whether the use of ozone autohemotherapy is associated with a&#xD;
      decrease in time to clinical improvement&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2020</start_date>
  <completion_date type="Actual">May 26, 2020</completion_date>
  <primary_completion_date type="Actual">May 19, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to clinical improvement</measure>
    <time_frame>28 days</time_frame>
    <description>Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate &lt;24 per minute, oxygen saturation &gt;94% on room air, and absence of cough) for at least 72 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with Clinical improvement at day 14</measure>
    <time_frame>14 days</time_frame>
    <description>Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate &lt;24 per minute, oxygen saturation &gt;94% on room air, and absence of cough) for at least 72 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with Clinical improvement at day 28</measure>
    <time_frame>28 days</time_frame>
    <description>Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate &lt;24 per minute, oxygen saturation &gt;94% on room air, and absence of cough) for at least 72 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to a 2-fold decrease of C-protein reactive from baseline</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to a 2-fold decrease of ferritin from baseline</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to a 2-fold decrease of Lactate Dehydrogenase from baseline</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to a 2-fold decrease of D-dimer from baseline</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>COVID-19 Pneumonia</condition>
  <arm_group>
    <arm_group_label>Ozone autohemotherapy plus standard treatment</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment alone</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        - Adults &gt;18yo hospitalised patients confirmed COVID-19 infection (diagnosed by&#xD;
        nasopharyngeal swab performed on admission), with severe pneumonia with baseline chest&#xD;
        X-ray abnormalities + oxygen saturation &lt;94% on room air, and tachypnea with respiratory&#xD;
        rate exceeding 30 per minute.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission)&#xD;
&#xD;
          -  severe pneumonia with baseline chest X-ray abnormalities;&#xD;
&#xD;
          -  Oxygen saturation &lt;94% on room air, and tachypnea with respiratory rate exceeding 30&#xD;
             per minute.&#xD;
&#xD;
          -  Informed consent signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not willing to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Policlinic Ibiza Hospital</name>
      <address>
        <city>Ibiza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta</investigator_affiliation>
    <investigator_full_name>Marc Vives</investigator_full_name>
    <investigator_title>Clinical Research Lead, MD, PhD, EDAIC</investigator_title>
  </responsible_party>
  <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>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </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/NCT04444531
org study id: COVID Networking group
nct id: NCT04444531
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective is to determine whether the use of ozone autohemotherapy is associated with a
      decrease in time to clinical improvement
observational model: Cohort
time perspective: Prospective
measure: Time to clinical improvement
time frame: 28 days
description: Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.
measure: Rate of patients with Clinical improvement at day 14
time frame: 14 days
description: Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.
measure: Rate of patients with Clinical improvement at day 28
time frame: 28 days
description: Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.
measure: Time to a 2-fold decrease of C-protein reactive from baseline
time frame: 28 days
measure: Time to a 2-fold decrease of ferritin from baseline
time frame: 28 days
measure: Time to a 2-fold decrease of Lactate Dehydrogenase from baseline
time frame: 28 days
measure: Time to a 2-fold decrease of D-dimer from baseline
time frame: 28 days
arm group label: Ozone autohemotherapy plus standard treatment
arm group label: Standard treatment alone
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
investigator full name: Marc Vives
investigator title: Clinical Research Lead, MD, PhD, EDAIC
mesh term: COVID-19
mesh term: Pneumonia
sharing ipd: Yes
ipd info type: Study Protocol