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/NCT05986435</url>
    </required_header>
    <id_info>
      <org_study_id>PROCOVER</org_study_id>
      <nct_id>NCT05986435</nct_id>
    </id_info>
    <brief_title>Long-term Follow-up Study of COVID-19</brief_title>
    <official_title>Long-term Large Sample Multicenter Follow-up Study of COVID-19</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn the long-term prognosis of patients and the&#xD;
        clinical characteristics of complications, which is of great significance for treatment of&#xD;
        novel coronavirus infection pneumonia.&#xD;
  &#xD;
        This trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test&#xD;
        results. This trial does not involve the use of specific drug. Participants's health and&#xD;
        psychological status will be observed at the preset time points. The blood, feces, urine&#xD;
        samples of patients will be collected for relevant tests.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After the patients are enrolled, record the patient's treatment regimens, blood routine&#xD;
        results, blood biochemistry results, cytokines results, lung imaging results, and cranial&#xD;
        imaging results, understand the patient's current clinical manifestations, evaluate the&#xD;
        patient's psychological status and quality of life, and collect samples of the patients'&#xD;
        blood, feces, urine, and other related tests.&#xD;
  &#xD;
        Collection of clinical samples: collect blood, urine, throat swabs and other samples from&#xD;
        patients with confirmed novel coronavirus pneumonia (Nucleic acid test positive), and collect&#xD;
        samples for relevant tests at 3 months, 6 months, 12 months, 18 months, 24 months and 36&#xD;
        months after discharge of patients, and record the clinical manifestations of patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 20, 2020</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>clinical manifestation</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>psychological status</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>quality of life scores</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cranial imaging results</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung imaging results</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cytokines level</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blood biochemistry results</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>routine blood test results</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>treatment regimens</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>survival rate</measure>
      <time_frame>3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">5700</enrollment>
    <condition>COVID-19</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        There are many patients who are prospectively observed. Their samples will be collected. The&#xD;
        samples will include blood, urine, throat swabs etc.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The inpatients with positive SARS CoV-2 nucleic acid test results will be included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with confirmed COVID-19&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Combined infection with influenza virus, mycoplasma, and chlamydia.&#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>Qin Ning, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science &amp; Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qin Ning, Professor</last_name>
      <phone>+8613971521450</phone>
      <email>qning@vip.sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science &amp; Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qin Ning</last_name>
        <phone>+8613971521450</phone>
        <email>qning@vip.sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Wuhan Seventh Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qin You Yan</last_name>
        <phone>18071702539</phone>
        <email>971716425@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>Qin Ning</investigator_full_name>
      <investigator_title>Director, department of infection</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <!-- 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/NCT05986435
  org study id: PROCOVER
  nct id: NCT05986435
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn the long-term prognosis of patients and the
        clinical characteristics of complications, which is of great significance for treatment of
        novel coronavirus infection pneumonia.
  
        This trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test
        results. This trial does not involve the use of specific drug. Participants's health and
        psychological status will be observed at the preset time points. The blood, feces, urine
        samples of patients will be collected for relevant tests.
  After the patients are enrolled, record the patient's treatment regimens, blood routine
        results, blood biochemistry results, cytokines results, lung imaging results, and cranial
        imaging results, understand the patient's current clinical manifestations, evaluate the
        patient's psychological status and quality of life, and collect samples of the patients'
        blood, feces, urine, and other related tests.
  
        Collection of clinical samples: collect blood, urine, throat swabs and other samples from
        patients with confirmed novel coronavirus pneumonia (Nucleic acid test positive), and collect
        samples for relevant tests at 3 months, 6 months, 12 months, 18 months, 24 months and 36
        months after discharge of patients, and record the clinical manifestations of patients.
  observational model: Other
  time perspective: Other
  measure: clinical manifestation
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  measure: psychological status
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  measure: quality of life scores
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  measure: cranial imaging results
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  measure: lung imaging results
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  measure: cytokines level
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  measure: blood biochemistry results
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  measure: routine blood test results
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  measure: treatment regimens
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  measure: survival rate
  time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
  There are many patients who are prospectively observed. Their samples will be collected. The
        samples will include blood, urine, throat swabs etc.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Qin Ning, Professor
  role: Principal Investigator
  affiliation: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
  last name: Qin Ning, Professor
  phone: +8613971521450
  email: qning@vip.sina.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Qin Ning
  investigator title: Director, department of infection
  mesh term: COVID-19