<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/NCT04409275</url>
  </required_header>
  <id_info>
    <org_study_id>INC-CVD-2020-01</org_study_id>
    <nct_id>NCT04409275</nct_id>
  </id_info>
  <brief_title>LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION</brief_title>
  <acronym>INC-CVD-202001</acronym>
  <official_title>STUDY OF THE APPEARANCE OF LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para la Investigación del Hospital Clínico de Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación para la Investigación del Hospital Clínico de Valencia</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>
      Prospective, observational, multicenter study that will evaluate the changes in lung function&#xD;
      that patients admitted with SARS-CoV-2 pneumonia will present according to the level of&#xD;
      severity at 4, 12, 26 and 52 weeks after hospital discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project consists of a prospective, observational, multicenter study that will evaluate&#xD;
      changes in lung function (forced spirometry, measurement of static lung volumes using&#xD;
      plethysmography and pulmonary carbon monoxide diffusion test) that patients admitted with&#xD;
      pneumonia will present. caused by SARS-CoV-2 according to the level of severity at 4, 12, 26&#xD;
      and 52 weeks after discharge from hospital. Restrictive pulmonary abnormalities will be&#xD;
      confirmed by imaging tests (high resolution chest CT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary fibrotic changes, short and medium term</measure>
    <time_frame>12 months</time_frame>
    <description>To analyze the number of patients who will develop pulmonary fibrotic changes, in the short and medium term, after surviving a bilateral pulmonary infection by SARS-CoV-2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of lung function impairment</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>To study the degree of lung function impairment, specifically the restrictive changes in functional capacity and diffusion alterations and its relationship with clinical variables.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biological markers</measure>
    <time_frame>1 month</time_frame>
    <description>Examine the biological markers in the patients who will present this dysregulation of the curative response that will give rise to pulmonary fibrosing phenomena.</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Pulmonary Fibrosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted with pneumonia caused by SARS-CoV-2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted for bilateral pneumonia caused by SARS-CoV-2 (confirmed by PCR).&#xD;
&#xD;
          -  Age over 18 years.&#xD;
&#xD;
          -  Acceptance of informed consent.&#xD;
&#xD;
          -  Life expectancy over 1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a previous diagnosis of interstitial lung disease.&#xD;
&#xD;
          -  Inability to attend review visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pulmonary Department. Hospital Clinico.</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaime Signes-Costa, MD, PhD</last_name>
      <phone>34 961973500</phone>
      <phone_ext>973904</phone_ext>
      <email>jaimesignescosta@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pulmonary Fibrosis</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/NCT04409275
org study id: INC-CVD-2020-01
nct id: NCT04409275
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, observational, multicenter study that will evaluate the changes in lung function
      that patients admitted with SARS-CoV-2 pneumonia will present according to the level of
      severity at 4, 12, 26 and 52 weeks after hospital discharge.
The project consists of a prospective, observational, multicenter study that will evaluate
      changes in lung function (forced spirometry, measurement of static lung volumes using
      plethysmography and pulmonary carbon monoxide diffusion test) that patients admitted with
      pneumonia will present. caused by SARS-CoV-2 according to the level of severity at 4, 12, 26
      and 52 weeks after discharge from hospital. Restrictive pulmonary abnormalities will be
      confirmed by imaging tests (high resolution chest CT).
observational model: Case-Only
time perspective: Prospective
measure: Pulmonary fibrotic changes, short and medium term
time frame: 12 months
description: To analyze the number of patients who will develop pulmonary fibrotic changes, in the short and medium term, after surviving a bilateral pulmonary infection by SARS-CoV-2
measure: Degree of lung function impairment
time frame: 6 and 12 months
description: To study the degree of lung function impairment, specifically the restrictive changes in functional capacity and diffusion alterations and its relationship with clinical variables.
measure: Biological markers
time frame: 1 month
description: Examine the biological markers in the patients who will present this dysregulation of the curative response that will give rise to pulmonary fibrosing phenomena.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pulmonary Fibrosis