xml: <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/NCT06006884</url>
    </required_header>
    <id_info>
      <org_study_id>23-001888</org_study_id>
      <nct_id>NCT06006884</nct_id>
    </id_info>
    <brief_title>A Study of Post COVID-19 Mechanisms for Chronic Lung Sequelae</brief_title>
    <official_title>Uncover Mechanisms Underlying the Development of Chronic Lung Sequelae Post COVID-19</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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 purpose of this study is to understand why some people experience long term effects, such&#xD;
        as shortness of breath and fatigue, after a severe COVID-19 infection&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Each participant will be in the study for approximately 12 months and will be required to&#xD;
        come to Mayo Clinic for 3 visits. These visits will take place approximately 2-3 months after&#xD;
        confirmed COVID-19 diagnosis (visit 1), 6 months after diagnosis (visit 2), and 12 months&#xD;
        after diagnosis (visit 3).&#xD;
  &#xD;
        Comprehensive clinical evaluation and symptom characterization, quantitative lung CT image&#xD;
        analysis and pulmonary function testing, and quality of life questionnaires will be obtained&#xD;
        at each visit. Bronchoscopy with BAL (collected at visits 1 and 3 only) and blood samples&#xD;
        (collected at all visits) will dissect the dynamic immunological and molecular signatures in&#xD;
        the respiratory tract and in the circulation longitudinally. We will also perform highly&#xD;
        sensitive viral reservoir or remnant assays to address the potential contribution of viral&#xD;
        factors in regulating chronic lung conditions post-acute COVID-19.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2027</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>Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae</measure>
      <time_frame>4 years</time_frame>
      <description>This study will expand on prior observations from a previous study and discover potential drivers and targets for therapy of post-acute COVID-19 lung disease by recruiting a larger group of COVID-19 convalescents, following up longitudinally up to 12 months after acute infection. This longitudinal approach will allow for assess immune dysregulation and establish the etiology of lung sequelae of COVID-19</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">75</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Sequelae group</arm_group_label>
      <description>COVID-19 convalescents that recover from prior severe acute diseases requiring hospitalization and who will be at high risk of chronic lung sequelae (with an estimate of &gt;50% having moderate to severe sequelae based on current literature)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Recovery group</arm_group_label>
      <description>Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bronchoscopies and Bronchoalveolar Lavages (BALs)</intervention_name>
      <description>Bronchoscopies use a thin, lighted tube, which enters through the mouth or nose and moves down the throat to the airways to look at the lungs. BALs are done during bronchoscopies to collect samples from the lungs for testing. During this procedure, a saline solution is put through the tube to wash the airways and collect a fluid sample.</description>
      <arm_group_label>Recovery group</arm_group_label>
      <arm_group_label>Sequelae group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Chest Tomography (CT)</intervention_name>
      <description>X-ray to create images of the bones and internal organs of the body</description>
      <arm_group_label>Recovery group</arm_group_label>
      <arm_group_label>Sequelae group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Electrocardiogram (ECG)</intervention_name>
      <description>Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs.</description>
      <arm_group_label>Recovery group</arm_group_label>
      <arm_group_label>Sequelae group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Pulmonary function tests (PFTs)</intervention_name>
      <description>Testing to measure how well lungs are working</description>
      <arm_group_label>Recovery group</arm_group_label>
      <arm_group_label>Sequelae group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>6 minute walk test (6MWT)</intervention_name>
      <description>Walking test to see how well the lungs function with exercise over 6 minutes</description>
      <arm_group_label>Recovery group</arm_group_label>
      <arm_group_label>Sequelae group</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Fecal samples will be stored for potential determination of gut microbiome using 16S&#xD;
        sequencing in the future if needed.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          COVID-19 patient records from Mayo Clinic, Rochester MN and Mayo Clinic Health System sites&#xD;
          will be reviewed for potential enrollment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For the Sequelae Group&#xD;
  &#xD;
            -  Age ≥18 years at screening, PCR confirmed COVID19 illness (+PCR defines day 0 of&#xD;
               illness), hospitalization for COVID-19, absence of pre-existing history of&#xD;
               interstitial lung disease, or significant other lung disease.&#xD;
  &#xD;
            -  Severity of illness will be categorized as moderate disease (supplemental oxygen need&#xD;
               1-8L at any time during hospitalization), severe disease (need for high flow oxygen&#xD;
               delivery ≥8L at any time during hospitalization) and critical illness (need for ICU&#xD;
               admission or mechanical ventilation).&#xD;
  &#xD;
          Control Recovery Group&#xD;
  &#xD;
            -  Age ≥18 years at screening&#xD;
  &#xD;
            -  PCR confirmed COVID-19 cases who had nonsymptomatic or mild acute infection that do&#xD;
               not require hospitalization 7,48,49&#xD;
  &#xD;
            -  Absence of pre-existing history of interstitial lung disease, or significant other&#xD;
               lung disease, absence of any ongoing respiratory and systemic symptoms.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to provide informed consent, evidence of pre-existing interstitial lung&#xD;
               disease or chronic lung disease;&#xD;
  &#xD;
            -  Active cigarette smoking, vaping or other inhalation use.&#xD;
  &#xD;
            -  Immunocompromised host status due to ongoing therapy with methotrexate, CellCept,&#xD;
               azathioprine, rituximab, cyclophosphamide or other biologic agents;&#xD;
  &#xD;
            -  &gt; 20 pack year smoking history.&#xD;
  &#xD;
            -  History of chemotherapy or radiation therapy in the last two years; and pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Robert Vassallo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mayo Clinic Minnesota</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chris Roberts</last_name>
        <phone>800-753-1606</phone>
        <email>roberts.chris@mayo.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Robert Vassallo</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>COVID-19</keyword>
    <keyword>SARS-CoV-2</keyword>
    <keyword>Long COVID</keyword>
    <keyword>chronic lung sequelae</keyword>
    <keyword>post-acute</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dimercaprol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006884
  org study id: 23-001888
  nct id: NCT06006884
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to understand why some people experience long term effects, such
        as shortness of breath and fatigue, after a severe COVID-19 infection
  Each participant will be in the study for approximately 12 months and will be required to
        come to Mayo Clinic for 3 visits. These visits will take place approximately 2-3 months after
        confirmed COVID-19 diagnosis (visit 1), 6 months after diagnosis (visit 2), and 12 months
        after diagnosis (visit 3).
  
        Comprehensive clinical evaluation and symptom characterization, quantitative lung CT image
        analysis and pulmonary function testing, and quality of life questionnaires will be obtained
        at each visit. Bronchoscopy with BAL (collected at visits 1 and 3 only) and blood samples
        (collected at all visits) will dissect the dynamic immunological and molecular signatures in
        the respiratory tract and in the circulation longitudinally. We will also perform highly
        sensitive viral reservoir or remnant assays to address the potential contribution of viral
        factors in regulating chronic lung conditions post-acute COVID-19.
  observational model: Cohort
  time perspective: Prospective
  measure: Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae
  time frame: 4 years
  description: This study will expand on prior observations from a previous study and discover potential drivers and targets for therapy of post-acute COVID-19 lung disease by recruiting a larger group of COVID-19 convalescents, following up longitudinally up to 12 months after acute infection. This longitudinal approach will allow for assess immune dysregulation and establish the etiology of lung sequelae of COVID-19
  arm group label: Sequelae group
  description: COVID-19 convalescents that recover from prior severe acute diseases requiring hospitalization and who will be at high risk of chronic lung sequelae (with an estimate of >50% having moderate to severe sequelae based on current literature)
  arm group label: Recovery group
  description: Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms
  intervention type: Procedure
  intervention name: Bronchoscopies and Bronchoalveolar Lavages (BALs)
  description: Bronchoscopies use a thin, lighted tube, which enters through the mouth or nose and moves down the throat to the airways to look at the lungs. BALs are done during bronchoscopies to collect samples from the lungs for testing. During this procedure, a saline solution is put through the tube to wash the airways and collect a fluid sample.
  arm group label: Recovery group
  arm group label: Sequelae group
  intervention type: Diagnostic Test
  intervention name: Chest Tomography (CT)
  description: X-ray to create images of the bones and internal organs of the body
  arm group label: Recovery group
  arm group label: Sequelae group
  intervention type: Diagnostic Test
  intervention name: Electrocardiogram (ECG)
  description: Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs.
  arm group label: Recovery group
  arm group label: Sequelae group
  intervention type: Diagnostic Test
  intervention name: Pulmonary function tests (PFTs)
  description: Testing to measure how well lungs are working
  arm group label: Recovery group
  arm group label: Sequelae group
  intervention type: Diagnostic Test
  intervention name: 6 minute walk test (6MWT)
  description: Walking test to see how well the lungs function with exercise over 6 minutes
  arm group label: Recovery group
  arm group label: Sequelae group
  Fecal samples will be stored for potential determination of gut microbiome using 16S
        sequencing in the future if needed.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Robert Vassallo, MD
  role: Principal Investigator
  affiliation: Mayo Clinic
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Robert Vassallo
  investigator title: Principal Investigator
  mesh term: COVID-19
  mesh term: Dimercaprol
  sharing ipd: No